FDA
Paid $5.76B: Merck's Keytruda Triplet Fails Both RCC Endpoints
Merck and Eisai's Phase 3 LITESPARK-012 study failed Tuesday.
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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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
Cleared Phase 3 Twice, Roche's Fenebrutinib Carries an 8-to-1 Death Imbalance
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
Doubles Relapse-Free Interval: Roche's MS Pill Beats Aubagio, 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 Review to 2 Months, Sends Compass Up 25%
FDA is directed to grant Commissioner's National Priority Vouchers to breakthrough-designated psychedelic drugs under an executive order Trump signed…
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 Targets FDA for Darovasertib After Phase 3 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 Hits Late-Stage Benchmark for Rare Eye Cancer Drug, Plans Accelerated Filing
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 as Kennedy-Backed Charter Rewrites Panel Mission
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's Foundayo Clears FDA; Novo's Oral Wegovy Holds 5-Point Efficacy 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 Novo Nordisk's Higher-Dose Wegovy in 54 Days
FDA approved Novo Nordisk's 7.2mg Wegovy HD in 54 days via the CNPV fast-track, handing Novo a pricing lever and leaving insurers to argue the math.
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.
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.
