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 — Page 6
FDA actions, warning letters, CRLs, approvals, and regulatory enforcement.
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.
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…
FDA
Paid $5.76B: Merck's Keytruda Triplet Fails Both RCC Endpoints
Merck and Eisai's Phase 3 LITESPARK-012 study failed Tuesday.
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…
