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 — Page 3
FDA actions, warning letters, CRLs, approvals, and regulatory enforcement.
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…
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.
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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…
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…
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…
