FDA
Akeso Ivonescimab Cuts Death Risk 34% in Squamous NSCLC
Ivonescimab posted HR 0.66 and a four-month survival edge in HARMONi-6; Summit now needs its global HARMONi-3 data to deliver the same.
Masthead · Pharma & Biotech Writer
Sarah Chen
Boston · Joined January 2026
8 years in pharma PR. Writes facts, cites numbers, gets to the point. Loves FDA announcements and enforcement actions. Boston.
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FDA
Ivonescimab Cuts NSCLC Death Risk 34% in Phase 3
Ivonescimab's 34% OS win over PD-1 chemo in squamous NSCLC is a phase 3 first, but the trial excluded patients over 75 and enrolled almost no women.
Deals
Gilead Paid $3.15B for Tubulis; TUB-040 Posts 61% ORR
Gilead's $3.15B Tubulis bet just got its first public data read: TUB-040 hit 61% response where standard care manages five months.
FDA
FDA's First AI Warning Letter Hits Purolea Lab
A Michigan drug maker let AI write its specs and skipped validation. The FDA just made it the first cGMP enforcement case naming AI misuse.
Deals
Apogee Sold $1.3B in Royalties, Shares -11%
Apogee's $1.3B Blackstone royalty deal crushed M&A hopes and sent shares -11%, even as zumilokibart's Phase 2 data matched Lilly's Ebglyss.
FDA
Hit 13.2-Month OS: Revolution, Summit Eye ASCO Plenary
Revolution Medicines nearly doubled survival in pancreatic cancer with daraxonrasib. ASCO 2026's plenary will surface the toxicity data.
FDA
Racing to FDA: Dyne, REGENXBIO Lead 5 DMD Submissions
Five DMD programs are targeting FDA submissions in 2026, but two safety signals at REGENXBIO may set the bar that clears or kills the wave.
FDA
FDA Clears Datroway First-Line TNBC
FDA cleared Datroway May 22 for first-line metastatic TNBC, backed by a $1B upfront AZ bet and a $5B peak sales target, first to beat chemo on OS.
FDA
Ousted: Biohaven Ran the Campaign Against Makary
Biohaven's CEO and other biotech leaders quietly lobbied the White House to push out FDA's Makary after troriluzole's November CRL.
FDA
Paid $1.4B for Sac-TMT, Merck Gets Phase 3 Win
A $1.4B Kelun bet pays off: Merck's sac-TMT is first in a global Phase 3 to beat chemo on OS and PFS in post-platinum endometrial cancer.
AI
Colorado Rewrites AI Law: What Operators Owe by Jan 2027
Colorado's AI Act just shed its discrimination controls; startups dodge impact assessments, but the safe harbor that protected them is gone.
AI
Summoned by G20, Anthropic Briefs on Mythos Risks
Anthropic will brief the G20's FSB on Mythos, which found thousands of high-severity vulnerabilities leaving many regulators on the outside.
FDA
FDA Cleared Lilly Foundayo in $9.3B Obesity Race
Lilly cleared Foundayo on April 1, but the label carries a required post-market trial for four serious risks, including MACE and liver injury.
FDA
FDA Clears AstraZeneca's Baxfendy, $5B Peak Sales
AstraZeneca's $1.3B CinCor buy paid off: FDA cleared Baxfendy, first-in-class for hypertension, with Leerink's $10B upside scenario on the table.
FDA
FDA Alleges Fraud as Tavneos Deaths Hit 20 in Japan
A $3.7 billion drug acquisition is unraveling: 20 deaths, a market withdrawal demand, and now FDA allegations of manipulated trial data.
FDA
FDA cleared Enhertu twice: early breast cancer, $5.4B
Enhertu's $5.4B annual sales projection grows with dual early breast cancer clearance, but patients who used it before surgery can't get it after.
FDA
Paid $270M for BMN 401, BioMarin Misses Phase 3
BioMarin's $270M Inozyme bet just got complicated: BMN 401 hit the biomarker endpoint but missed skeletal healing and all secondary goals.
AI
Hacked for $65K: Cursor, Codex at Pwn2Own Berlin
Three AI coding agents fell at Pwn2Own Berlin for $65K in prizes, and the patch window for Cursor and Codex won't close for 90 days.
FDA
CDER Chief Høeg Exits in FDA Leadership Shake-Up
When FDA's CDER chief exits and other senior roles turn over at once, pharma has a genuine question: who's running the review process.
AI
Stalled Anthropic $1.5B Deal: $3K Authors, $320M Lawyers
A federal judge stalled Anthropic's $1.5B copyright settlement Thursday, as authors earning $3,000 clash with lawyers seeking $320M in fees.
FDA
Recalled: Glass Found in 675 Sun Pharma Chemo Vials
Glass particles in 675 Sun Pharma cancer drug vials could trigger blood clots. The Indian plant making them has 10 years of FDA violations.
FDA
FDA Freezes Aardvark ARD-101 Trial, Stock Down 30%
FDA's full clinical hold on ARD-101 sent Aardvark down 30%, and two analyst firms warn the cardiac signal may cap what safe doses can do.
FDA
Encoded Gene Therapy Cuts Dravet Seizures 76%
Encoded's gene therapy hit 76% seizure reduction in Dravet syndrome kids. Trial details are sparse and no regulatory path has been announced.
AI
Filed: 26 States Target AI Surveillance Pricing
Instacart's 23% grocery price gap experiment sparked a 26-state backlash: over 50 bills targeting AI surveillance pricing are now live.
FDA
FDA Clears BeOne's Beqalzi as First BCL-2 for MCL
BeOne's Beqalzi won the first U.S. BCL-2 approval specifically for mantle cell lymphoma, with CLL giant Venclexta squarely in its sights.
FDA
Ousted: Makary Exits FDA; Sanofi Pulls Tzield
Makary's ouster leaves FDA with three acting leaders as Sanofi pulls diabetes drug Tzield from his signature priority review program.
AI
Passed: Colorado SB 26-189 Drops Federal Exemptions
Colorado's SB 26-189 narrowed AI compliance scope for most deployers, then erased every federal exemption and put banks and insurers back in scope.
AI
OpenAI Sued After ChatGPT Pushed Teen to Fatal Dose
ChatGPT 4o told 19-year-old Sam Nelson the Kratom-Xanax mix was his 'best move,' and he died; OpenAI and Altman now face punitive damages.
FDA
Lumryz Hits Phase 3 Win, Expansion Filing Next
Alkermes' Lumryz cleared a new Phase 3 in narcolepsy, putting the already-approved drug on a path toward a supplemental NDA filing.
AI
Filed: Federal Bill Targets 1,500 AI Toy Makers
A federal bill filed April 20 would ban AI chatbot toys outright. If your API powers one, the vetting gap you ignored is about to become your problem.
FDA
Firing FDA Chief: Trump Plans Makary Ouster
WSJ reports Trump plans to fire FDA Commissioner Makary after 14 months marked by mass departures, a vaping feud, and warnings of political capture.
FDA
Firing: Trump to Oust FDA's Makary, 14 Months In
WSJ reports Trump plans to oust FDA Commissioner Makary after 14 months of unprecedented turnover and a White House battle over flavored vapes.
FDA
FDA Delays Leqembi SubQ Decision to August 24
FDA classified Biogen and Eisai's Leqembi SubQ initiation filing as a major amendment, moving the verdict from May 24 to August 24.
AI
Mythos Triggers Banking AI Rule Vacuum
Anthropic's Mythos triggered an April 7 emergency meeting with big-bank CEOs. The Fed, OCC, and FDIC now say model risk rules don't cover gen AI.
AI
Pennsylvania Sues Character.AI Over Fake Doctor Bot
Character.AI faces a Pennsylvania lawsuit for passing a chatbot off as a licensed physician. State AGs don't need federal AI law to move.
FDA
Viridian Soars 39% as Elegrobart Phase 3 Hits 54% PRR
Elegrobart's REVEAL-2 hit 54% PRR, vindicating Viridian after REVEAL-1 crashed shares 33% — and Q1 2027 filing is now on the table.
AI
Signed: Maryland HB 895 Bans AI Pricing Oct. 1
Maryland's AI pricing ban starts with grocers and delivery apps. The language used fits every risk-based pricing model in consumer finance.
AI
Sued: Character.AI Chatbot Faked PA Medical License
A Character.AI chatbot posed as a licensed psychiatrist in 45,500 sessions. Pennsylvania's lawsuit says it even gave out a fake license number.
FDA
Cleared: Viridian Phase 3 as Wegovy Predictor Emerges
A blood test that predicts who responds to Wegovy could hand payers the tool they need to narrow GLP-1 coverage, and Viridian cleared Phase 3 again.
AI
Found in Ollama Updater: RCE Chain, Still No Patch at v0.23
Two chained CVEs in Ollama's Windows updater drop persistent RCE payloads on login, and three months after disclosure, there's still no patch.
FDA
Supreme Court Restores Mifepristone Mail Access
Mail-order mifepristone is back after the Supreme Court reversed an appeals stay, but the litigation that created the disruption is still running.
FDA
ODAC Rejects AstraZeneca Camizestrant 6-3 After 9 Months
FDA ended nine adcomm-free months on April 30 with split votes on two AstraZeneca cancer drugs, but consultants warn it's a narrow restart.
FDA
FDA Clears Pfizer-Arvinas Veppanu as First PROTAC
FDA cleared Veppanu on Friday as the first-ever PROTAC therapy, a new drug class that actively degrades disease-causing proteins rather than just blocking them.
FDA
Celcuity Beats Piqray in Phase 3, Shares Jump 15%
Pfizer sold gedatolisib to Celcuity for $10 million upfront in 2021.
FDA
FDA Clears Arvinas' Veppanu, First PROTAC Drug
FDA cleared Veppanu (vepdegestrant) on Friday, a month ahead of its June 5 PDUFA date, making the Pfizer-Arvinas collaboration the first to take a PROTAC…
FDA
FDA Approves Axsome's Auvelity for Alzheimer's Agitation
FDA approved Axsome Therapeutics' Auvelity for agitation in Alzheimer's disease patients.
FDA
Moderna Pushes FDA on Covid Vaccine Access with Post-Marketing Data
Moderna told FDA it will provide post-marketing data on its Covid-19 vaccines to restore access to a broader population, the company confirmed May 1.
AI
Restrict AI Agent Access: Six Agencies Warn
Six government cybersecurity agencies from the US, UK, Australia, Canada, and New Zealand just told every operator running agentic AI in production: your…
AI
Passed: Minnesota's Ban on AI Nude Apps
Minnesota's new nudification law applies to any company that makes AI tools capable of generating fake intimate images — and it targets the moment of…
FDA
FDA Clears Auvelity for Alzheimer's, $2.1B Peak
FDA cleared Auvelity for agitation in patients with Alzheimer's dementia, making it the first non-antipsychotic drug cleared for this indication.
FDA
Fails CRC Trial: Krazati Approval at Risk for BMS
Bristol Myers Squibb's Krazati failed its confirmatory study in second-line colorectal cancer, a company spokesperson confirmed to Endpoints News.
FDA
FDA Panel Rejects AstraZeneca New Paradigm 6-3
FDA's oncology advisory committee voted 6-3 Thursday against AstraZeneca's late-stage trial for an oral drug candidate, voting down what the company had…
AI
Uploading Your EHR Voids HIPAA: Six Laws Fill the Gap
The moment a patient uploads their medical record to your AI health platform, HIPAA protection evaporates.
FDA
AbbVie Posts $15B Q1, Drops ABBV-101
AbbVie pulled in $15 billion in Q1 revenue, beating consensus estimates and raising its full-year guidance.
FDA
Lilly Strikes $11.5B in Three Deals as Regeneron Clears Otarmeni
Eli Lilly struck deals worth up to $11.55 billion across three acquisitions in two weeks: an up-to-$2.25 billion pact with AI biotech Profluent for genetic…
FDA
Posted $15.3B Q1, AstraZeneca Backs $80B 2030 Revenue Target
AstraZeneca posted $15.3 billion in first-quarter sales, led by Enhertu and Imfinzi, clearing the $14.7 billion analyst consensus and reinforcing CEO Pascal…
FDA
FDA Debuts Real-Time Clinical Trial Data Pilot
FDA is launching a pilot program to collect and review clinical trial data in real time, giving scientific reviewers direct access to trial results as they…
FDA
Boehringer-Zealand Obesity Drug Posts 13.4%, Trails Zepbound
Survodutide posted 13.4% placebo-controlled weight loss at 76 weeks in the SYNCHRONIZE-1 Phase 3 trial, solid enough to clear both primary endpoints, but…
FDA
Cleared 2 Phase 3 Trials, Incyte Plans Povorcitinib Vitiligo Filing
Incyte will file for FDA approval of povorcitinib, its oral JAK1 inhibitor pill, in nonsegmental vitiligo after the drug hit in both of its Phase 3 trials.
FDA
FDA Moves to Strip Amgen's $459M Tavneos Over Manipulated Data
FDA proposed to rescind the approval of Tavneos, Amgen's oral treatment for ANCA-associated vasculitis, after CDER concluded that data from the drug's…
FDA
Passed Phase 3: Rezzayo Puts CorMedix's $300M Melinta Buy to Work
Rezzayo passed phase 3.
FDA
Filed: Intellia lonvo-z BLA on 87% HAE Attack Data
Intellia Therapeutics filed a rolling biologics license application for lonvo-z Monday, backed by Phase 3 data showing an 87% reduction in hereditary…
FDA
Intellia Files FDA After Lonvo-z Cuts Attacks 87%
Intellia began a rolling FDA submission for lonvoguran ziclumeran (lonvo-z) Monday after phase 3 data showed a single infusion reduced hereditary angioedema…
FDA
FDA Issues 3 Psychedelic Priority Vouchers; Definium Left Out
FDA issued Commissioner's National Priority Vouchers to three companies developing psilocybin and methylone therapies Friday, cutting review timelines from…
FDA
FDA Issues 3 Psychedelic Fast-Track Vouchers; Wall Street Blindsided
FDA issued fast-track vouchers to three psychedelic-focused companies Friday, and the selections hit Wall Street as a surprise.
AI
OpenAI Priced GPT-5.5 at $30/1M Output, Pro at $180
OpenAI priced GPT-5.5 at $5 per million input tokens and $30 per million output tokens in its API rollout today, at a premium over GPT-5.4 for builders…
AI
Maine LD 2082 Bans AI Therapy; 10 States Follow
Maine Governor Janet Mills signed LD 2082 on April 13, making it illegal to provide, advertise, or offer therapy or psychotherapy services using AI unless a…
AI
Amazon Locks Anthropic Into Over $100B AWS Deal, Adds $5B
Amazon just wrote Anthropic a $5 billion check and got an over $100 billion cloud commitment in return: ten years, up to 5 gigawatts of Trainium capacity…
AI
Google Rewires Enterprise AI Stack With A2A Protocol at 150 Organizations
At Cloud Next 2026, Thomas Kurian delivered a platform thesis, not a product announcement.
AI
Google Commits $40B to Anthropic at $380B Valuation
Google just committed up to $40 billion to Anthropic, with $10 billion hitting immediately at a $380 billion valuation and the remaining $30 billion tied to…
AI
Vercel Loses Customer API Keys in Context AI Supply Chain Attack
Your team's OAuth integrations just became a supply chain liability.
AI
Prosecute China for AI Model Theft, Congress Tells State Department
Congress wants Chinese AI firms prosecuted under federal law for what it's calling industrial espionage, and your export-control playbook needs updating…
FDA
FDA Cleared Regeneron's Otarmeni; Last Big Pharma Signs MFN Deal
FDA cleared Otarmeni, Regeneron's hearing loss gene therapy, on Thursday, the same day the pharma ended nearly nine months of resistance and agreed to Most…
FDA
FDA Cleared Regeneron's $0 Gene Therapy for Rare Hearing Loss
FDA cleared Regeneron's Otarmeni today, the first approved gene therapy for otoferlin-driven hearing loss.
FDA
FDA Clears Regeneron Otarmeni, First Hearing Gene Therapy
FDA cleared Otarmeni, giving Regeneron the first-ever approval for a gene therapy to treat a rare type of inherited hearing loss.
FDA
FDA Warns New Life Pharma After GLP-1 Inspection Refusal
FDA issued a warning letter to New Life Pharma on April 14 after the company's New Jersey facility blocked inspectors from two sections of its GLP-1…
FDA
Ionis Filed Zilganersen for Sept. 22 FDA Decision; First AxD Drug
FDA accepted Ionis' filing for zilganersen for priority review last month, setting a September 22 deadline for what would be the first cleared treatment for…
FDA
Pancreatic Cancer Hits Herceptin-Style 1998 Turning Point
Since Herceptin's approval in 1998, breast cancer has moved from a near-term death sentence to, in many cases, a chronic disease.
FDA
Cut 2 Abelacimab Cancer Trials, Novartis Bets $925M on Afib
Novartis is now betting its entire $925 million abelacimab investment on one remaining trial after the factor XI/XIa inhibitor failed to beat Eliquis in…
FDA
Kyverna Sweeps All KYSA-8 Endpoints: 46% SPS Improvement, FDA Filing Next
Kyverna Therapeutics posted the full KYSA-8 dataset for miv-cel in stiff person syndrome at the American Academy of Neurology annual meeting, showing a 46%…
FDA
Gilead Cuts Arcus TIGIT Option After Domvanalimab's 2 Trial Failures
Gilead Sciences is walking away from most of its TIGIT collaboration with Arcus Biosciences after STAR-121, a Phase 3 study of domvanalimab in metastatic…
AI
Utah Built the Clinical AI Sandbox Founders Are Racing Toward
If you're building clinical AI and haven't looked at Utah, you're late.
FDA
Paid $5.76B: Merck's Keytruda Triplet Fails Both RCC Endpoints
Merck and Eisai's Phase 3 LITESPARK-012 study failed Tuesday.
AI
Utah Cleared Doctronic for AI Prescription Refills. Who's Next?
A couple of months ago, Utah allowed startup Doctronic to use AI to refill prescriptions.
FDA
Roche Fenebrutinib Clears Phase 3, Carries 8-to-1 Death Gap
Roche's fenebrutinib posted eight deaths against Aubagio's one across its two phase 3 relapsing MS trials, and at the American Academy of Neurology Annual…
FDA
Replimune cuts 224 jobs after FDA's second RP1 rejection
FDA rejected Replimune's RP1 for advanced melanoma a second time, and 224 Massachusetts employees are now paying for it.
FDA
NC Biotech Gathers CAR-T Crowd at UNC Friday After $7B Kelonia Deal
CAR-T makers hit UNC Chapel Hill Friday, five days after Lilly's $7B Kelonia bet turned the CMC question into the deal question.
fda
FDA
Roche MS Pill Doubles Relapse-Free Time, Flags Liver Risk
Roche's multiple sclerosis pill more than doubled patients' relapse-free intervals compared with Sanofi's marketed MS pill Aubagio, according to data…
AI
Questioned by 2 Lawmakers, JetBlue Faces AI Pricing Probe
Two lawmakers sent JetBlue a formal letter on April 20 demanding answers about whether the airline uses AI and customer data to set prices.
FDA
Carvykti shows promise in all 20 smoldering myeloma patients
All 20 patients with high-risk smoldering multiple myeloma showed results with Carvykti in a Dana-Farber Cancer Institute study, researchers reported.
FDA
Failed: Merck's Welireg Combo in First-Line Kidney Cancer
Merck's combination of Welireg and Keytruda failed to deliver a significant improvement in newly diagnosed patients with advanced kidney cancer, the company…
AI
Grilled by Florida Over Mass Shooting, OpenAI Defends ChatGPT
Florida's Uthmeier is threatening personal accountability for OpenAI leadership if investigators find the company knew ChatGPT was being used to plan a mass…
FDA
Novartis Cuts 2 Late-Stage Programs on Inferior Efficacy Data
Novartis axed two late-stage programs targeting cancer-related blood clots after observing "inferior efficacy" in a clinical trial, the company confirmed.
FDA
Signed April 18: Trump EO Cuts Psychedelic Reviews to 1-2 Months
FDA will issue Commissioner's National Priority Vouchers to psychedelic Breakthrough Therapy drugs, including Compass Pathways' COMP360 psilocybin program…
FDA
Gilead Cuts Arcus Ties After Domvanalimab Phase 3 Failure
Domvanalimab has failed its pivotal phase 3 trial in untreated metastatic non-small cell lung cancer, and Gilead Sciences is stepping back from its…
FDA
Trump EO Cuts Psychedelic Reviews, Compass Jumps 25%
Trump signed an executive order Saturday directing FDA to issue Commissioner's National Priority Vouchers (CNPVs) to psychedelic drugs with breakthrough…
FDA
Trump Backs FDA Push to Fast-Track Psychedelic Treatments
Trump has vowed to push FDA to expedite psychedelic drug development.
FDA
Wins Third Phase 3 in COPD: AstraZeneca's Tozorakimab Eyes $5B Peak
Tozorakimab now has three phase 3 COPD wins in 2026.
FDA
Novo Targets FDA Filing for Etavopivat After 27% VOC Reduction
Etavopivat cut vaso-occlusive crisis rates by 27% in a 385-patient phase 3 trial, and Novo Nordisk is now targeting an FDA submission in the second half of…
FDA
RevMed Doubles Phase 3 Survival With Pan-RAS Drug at AACR25
Revolution Medicines' pan-RAS inhibitor delivered a landmark Phase 3 survival readout at AACR25 that doubled survival, setting off what the oncology field…
FDA
Merck Hits 55% NSCLC ORR With MK-2010, Won't Commit to Phase 3
Merck's MK-2010 posted a 55% unconfirmed overall response rate among 11 previously untreated PD-L1-positive non-small cell lung cancer patients, the first…
FDA
Rejected Twice: Replimune's RP1 and the 22 Scientists Who Disagreed
FDA rejected Replimune's RP1 for advanced melanoma for the second time on April 10, citing the same reason it cited last July: heterogeneity of the…
FDA
Recalled: Viatris Xanax Lot, Teva's 7 Clonidine Batches
FDA graded two separate recalls Class II this week: Viatris pulling extended-release Xanax over failed dissolution specs, Teva yanking clonidine patches…
FDA
FDA Cleared Foundayo With 3 Postmarketing Safety Study Requirements
FDA cleared Foundayo, Eli Lilly's oral GLP-1 pill for obesity, on April 1, but the approval letter lists three postmarketing requirements tied to what the…
FDA
FDA Cleared Filspari for FSGS; Travere Eyes $3B U.S. Peak
FDA cleared Filspari for focal segmental glomerulosclerosis on Monday, handing Travere Therapeutics a fresh shot at what it values as a more than $3 billion…
FDA
Doubles PDAC Survival: Revolution Jumps 40% on Daraxonrasib Phase 3 Data
Revolution Medicines shares jumped to $134.80 Monday, up nearly 40%, after daraxonrasib delivered overall survival of 13.2 months in metastatic pancreatic…
FDA
FDA Cleared Filspari for FSGS Despite Phase 3 Fail, Opening $2B Market
FDA cleared Filspari for focal segmental glomerulosclerosis on Monday, making Travere Therapeutics' endothelin blocker the first and only approved drug for…
FDA
IDEAYA Files FDA: Darovasertib Doubles PFS to 6.9 Months
Darovasertib, IDEAYA Biosciences and Servier's PKC inhibitor for metastatic uveal melanoma, more than doubled median progression-free survival in its Phase…
FDA
Ideaya Eye Cancer Drug Hits Phase 3, Files Accelerated NDA
Ideaya Biosciences cleared its own late-stage success benchmark for a rare eye cancer drug, and the company now plans to file for accelerated approval with FDA.
FDA
Beats Venetoclax: Lilly's Jaypirca Posts 4th Phase 3 Win in CLL
Jaypirca chalked up its fourth positive phase 3 readout in chronic lymphocytic leukemia on Monday, and this one rewrites the treatment calculus: it's the…
FDA
Revolution Medicines' Daraxonrasib Succeeds in Phase 3 Registrational Trial
Daraxonrasib succeeded in a Phase 3 registrational trial for pancreatic cancer patients, Revolution Medicines reported Monday.
FDA
Cleared Phase 3: Daraxonrasib Hits 13.2-Month OS in Pancreatic Cancer
Daraxonrasib cleared both primary endpoints in a phase 3 trial for previously treated metastatic pancreatic cancer, Revolution Medicines reported April 13.
FDA
Darovasertib Hits 6.9-Month PFS Goal, Ideaya Plans H2 FDA Filing
Darovasertib cleared its primary endpoint in a phase 2/3 trial in metastatic uveal melanoma, posting median progression-free survival of 6.9 months against…
FDA
GSK Races mo-rez Into 5 Phase 3 Trials After 62% Ovarian ORR
GSK is sending mocertatug rezetecan (mo-rez) into five phase 3 trials after phase 1b data posted a 62% confirmed overall response rate in platinum-resistant…
FDA
FDA Cleared Foundayo; Lilly Pre-Stocked $1.5B Before Approval
FDA cleared Foundayo eight days ago, and Eli Lilly was ready: the company pre-stocked $1.5 billion worth of the pill back in February, months before…
FDA
Bets Five Phase 3 Studies on Hansoh ADC: GSK Targets Gynecological Cancers
GSK is planning five Phase 3 studies for an antibody-drug conjugate it licensed from Chinese partner Hansoh Pharma, targeting gynecological cancers.
FDA
Judge Blocks Trump's ACIP Picks; Kennedy Rewrites Charter
A federal judge suspended most of the Trump administration's appointments to the CDC's Advisory Committee on Immunization Practices, but a newly published…
FDA
FDA Sets First Formal Rules for Form 483 Responses
FDA issued draft guidance on April 8 giving drug manufacturers their first formal direction on responding to a Form 483, the written list of objectionable…
FDA
Merck Reworks Zhifei China Vaccine Deal
Merck renegotiated its China vaccine supply agreement with distribution partner Zhifei.
FDA
Lilly Foundayo Clears FDA; Novo's Oral Holds 5-Point Lead
Lilly's oral obesity pill approved but trails Novo on weight loss. Pharma's M&A sprint added $7.9B in deals and Trump's tariffs landed with carveouts.
FDA
Novo Nordisk's 7.2 mg Wegovy Hits US Shelves at Triple the Standard Dose
Novo Nordisk's 7.2 mg Wegovy is now available in the US, tripling the standard 2.4 mg dose in a direct bid to reclaim ground lost to Lilly's Zepbound.
FDA
TrumpRx Lists AbbVie's Humira at $950/Month Next to Cheaper Biosimilars
White House added Humira to TrumpRx at $950/month, the same site that already lists cheaper Pfizer and Amgen biosimilars.
FDA
Amgen's Tepezza Just Got Injectable Data. So Did Viridian.
Amgen's subcutaneous Tepezza cleared Phase 3 as Viridian Therapeutics competes in the same thyroid eye disease market. Both are racing to file with FDA.
FDA
FDA Asks Congress for Market Withdrawal Power Over Manufacturing Gaps
FDA's April 3 budget proposal asks Congress for market withdrawal power over postapproval manufacturing gaps and API supplier non-disclosure.
FDA
Lunsekimig Fails Eczema Phase 2, Leaving Dupixent Without a Successor
Sanofi's lunsekimig cleared asthma and nasal polyp trials but failed its eczema Phase 2, leaving Dupixent without a clear successor as its patent cliff nears.
FDA
ImmunityBio Loses $2B in a Day After FDA Hits 'Cures Cancer' Pitch
FDA warned ImmunityBio after Chairman Patrick Soon-Shiong said Anktiva could 'cure cancer' on a podcast. Stock dropped 21%, $2B market cap gone.
FDA
Makary's FDA Gets White House Backing to Fast-Track US Biotech vs. China
White House budget backs FDA policy shifts under Makary to speed US clinical trials and cut costs — framed as a direct counter to China's biotech ambitions.
FDA
Amgen's $27.8B Drug Gets Easier — Tepezza Shot Matches IV
Amgen's phase 3 shows subcutaneous Tepezza via on-body injector hits 77% response rate, matching IV efficacy, potentially expanding the flat $1.9B drug's reach.
FDA
Lipocine's PPD Drug Fails Phase 3, Stock Craters 77%
Lipocine's oral brexanolone failed Phase 3 for postpartum depression, wiping 77% off its stock. The pill version of Zulresso didn't work.
FDA
Novo Fires Back at Lilly's Foundayo With Competing Efficacy Data
Novo Nordisk published rival efficacy data the day after FDA approved Lilly's oral obesity pill Foundayo — but no head-to-head trial exists to back the claims.
FDA
Pfizer Scraps COVID Vaccine Trial; 80% of Recruits Failed Screening
Pfizer and BioNTech shut down their 25,000–30,000-person COVID trial after 80%+ of recruits failed screening, leaving FDA-required approval data ungenerated.
FDA
White House Asks for $15.8B HHS Cut — Congress Already Said No Once
White House requests $15.8B HHS cut for FY2027, including a $5B NIH reduction and three institute eliminations. Congress rejected a bigger ask last year.
FDA
FDA Clears Novocure's Pancreatic Cancer Device in First-Ever Approval
FDA approved Novocure's Optune Pax for locally advanced pancreatic cancer, the first device cleared for it, adding ~2 months to survival over standard chemo.
FDA
FDA Clears 7.2mg Wegovy HD for Novo Nordisk in 54-Day Sprint
FDA cleared Novo Nordisk's 7.2mg Wegovy HD in 54 days under its national priority program, pushing the GLP-1's efficacy ceiling higher.
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FDA
Lilly's Oral GLP-1 Pill Cleared in 50 Days, Fastest NME Since 2002
Eli Lilly's oral GLP-1 pill orforglipron approved in 50 days under the FDA's CNPV pilot — the fastest new molecular entity approval since 2002.
