FDA Drug Approval Marks a First for a Disease — But It’s Not Autism / MedCity
Frank Vinluan / medcitynews - Leucovorin is now approved for cerebral folate deficiency months after FDA Commissioner Marty Makary claimed the decades-old generic drug had promise for treating autism. The FDA’s review was based on published literature and real-world evidence.The post …
#healthcare #pharmaceuticals #publichealth #governmentpolicy #drugdevelopment #fda #autism
Sunday, March 15, 2026, 12:22 pm / permalink 20779 / 4 stories in 32 hrs
Ipsen pulls cancer drug Tazverik from market over safety risks / Endpoints
Nicole DeFeudis / endpoints - Ipsen is pulling its cancer drug Tazverik from the market after an independent data monitoring committee found safety concerns in a confirmatory trial. The committee reported cases of secondary cancers that begin in blood-forming tissue ...
#healthcare #pharmaceuticals #biotech #drugdevelopment #fda #productrecall #oncology #cancerresearch
Saturday, March 14, 2026, 12:23 am / permalink 20738 / 3 stories in 2 days
FDA Transparency Push Expands to Monitoring Safety of Vaccines and Other Regulated Products / MedCity
Frank Vinluan / medcitynews - The FDA said consolidating safety reporting into a single platform, the Adverse Event Monitoring System (AEMS), will increase transparency and reduce costs. But like the legacy systems it replaces, AEMS reports are unverified so causation and frequency of…
#healthcare #pharmaceuticals #publichealth #governmentpolicy #biotech #fda #vaccinesafety #digitalhealth #animalhealth
Thursday, March 12, 2026, 5:23 pm / permalink 20659 / 7 stories in 4 days
New FDA bonus pilot to address 'workforce challenges' / Endpoints
Max Bayer / endpoints - A new bonus pilot program meant to reward fast-working FDA reviewers will be funded in part by money from industry user fees, the first details on how Commissioner Marty Makary plans to finance the incentive ...
#healthcare #pharmaceuticals #governmentpolicy #biotech #drugdevelopment #fda #healthcarefinance
Saturday, March 7, 2026, 12:23 am / permalink 20312 / 2 stories in 9 days
FDA lifts hold on Intellia trial / Beckers
Ella Jeffries / beckershospitalreview - The FDA has lifted a clinical hold on Intellia Therapeutics’ phase 3 Magnitude trial of nexiguran ziclumeran, or nex-z. The trial was paused Oct. 29 after a patient developed grade 4 liver transaminase elevations and elevated bilirubin following a Sept. 3…
#healthcare #pharmaceuticals #biotech #drugdevelopment #fda
Saturday, March 7, 2026, 12:23 am / permalink 20309 / 4 stories in 9 days
FDA vaccine chief to step down in April / Beckers
Ella Jeffries / beckershospitalreview - Vinay Prasad, MD, the FDA’s top regulator of vaccines and cell and gene therapies, will step down at the end of April, an agency spokesperson confirmed to Becker’s. Dr. Prasad joined the agency in 2025 on a one-year sabbatical from the University of Calif…
#healthcare #publichealth #governmentpolicy #biotech #drugdevelopment #fda #vaccinesafety #infectiousdisease
Friday, March 6, 2026, 6:23 pm / permalink 20292 / 3 stories in 10 days
Groundbreaking new drug shows promise for treating children with a devastating form of epilepsy / LiveScience
livescience - An experimental treatment reduces seizures and other symptoms in children with a type of epilepsy called Dravet syndrome.
#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #fda #infanthealth
Thursday, March 5, 2026, 4:23 pm / permalink 20233 / 4 stories in 11 days
Boehringer wins accelerated approval for first-line use of lung cancer drug / Endpoints
Lei Lei Wu / endpoints - The FDA greenlit an expanded label for Boehringer Ingelheim’s lung cancer drug Hernexeos, marking the first use of the Commissioner's National Priority Voucher for a new indication. Boehringer won an accelerated
#healthcare #pharmaceuticals #publichealth #governmentpolicy #biotech #drugdevelopment #fda #oncology
Saturday, February 28, 2026, 12:23 am / permalink 19927 / 9 stories in 16 days
Patient dies in MacroGenics' cancer study, FDA puts trial on hold / Endpoints
Max Gelman / endpoints - The FDA has placed a partial clinical hold on MacroGenics’ Phase 2 study in gynecologic cancers after one patient died and three others experienced life-threatening side effects, the company disclosed Tuesday. The patient who died ...
#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #fda #oncology
Saturday, February 28, 2026, 12:23 am / permalink 19925 / 3 stories in 16 days
FDA Launches Framework to Accelerate Individualized Therapies for Ultra-Rare Diseases 2026 / OncoDaily
oncodaily - The U.S. Food and Drug Administration (FDA) has released groundbreaking draft guidance introducing a new regulatory framework designed to accelerate the development and approval of individualized therapies for patients with […]
#healthcare #pharmaceuticals #publichealth #governmentpolicy #biotech #drugdevelopment #fda
Tuesday, February 24, 2026, 12:25 pm / permalink 19669 / 6 stories in 20 days
ChatGPT Health performance in a structured test of triage recommendations / Nature
Ashwin Ramaswamy / nature - Nature Medicine, Published online: 23 February 2026; doi:10.1038/s41591-026-04297-7A stress test of ChatGPT Health triage revealed missed high-risk emergencies and inconsistent activation of suicide-crisis safeguards, raising safety concerns for consumer-…
#healthcare #publichealth #governmentpolicy #fda #digitalhealth #medicaldevices
Tuesday, February 24, 2026, 11:25 am / permalink 19660 / 18 stories in 20 days
Gilead to acquire cell therapy manufacturer for $7.8B / Beckers
Paige Twenter / beckershospitalreview - In a deal worth $7.8 billion, Gilead Sciences has entered a definitive agreement to acquire Arcellx, a biotech company developing a cell therapy for multiple myeloma. Gilead announced the acquisition agreement a few months after Arcellx published positive…
#healthcare #pharmaceuticals #biotech #mergersandacquisitions #corporatetakeover #drugdevelopment #fda #oncology
Monday, February 23, 2026, 4:23 pm / permalink 19605 / 7 stories in 21 days
‘You’re not the Lone Ranger’ anymore: Medical education evolves for team-based care / Beckers
Paige Twenter / beckershospitalreview - As U.S. healthcare increasingly adopts team-based care, medical schools are working to prepare students for future care delivery models, according to a Feb. 18 article from the Association of American Medical Colleges. Team-based care, or a coordinated ba…
#healthcare #publichealth #fda #digitalhealth #medicaldevices
Saturday, February 21, 2026, 12:22 pm / permalink 19529 / 3 stories in 23 days
Disc Medicine Rare Disease Drug Picked for Faster Regulatory Review Is Rejected by the FDA / MedCity
Frank Vinluan / medcitynews - The FDA asked for more data to determine whether Disc Medicine’s bitopertin is benefiting patients with erythropoietic protoporphyria, a rare blood disorder. Analysts say it’s a surprising delay considering bitopertin is one of the first drugs in a new FD…
#healthcare #pharmaceuticals #biotech #drugdevelopment #fda
Saturday, February 21, 2026, 6:22 am / permalink 19516 / 5 stories in 23 days
Predicting onset of symptomatic Alzheimerʼs disease with plasma p-tau217 clocks / Nature
Kellen K. Petersen / nature - Nature Medicine, Published online: 19 February 2026; doi:10.1038/s41591-026-04206-yPlasma p-tau217 tests used to develop clocks that predict when cognitively unimpaired individuals would develop symptoms of Alzheimerʼs disease.
#healthcare #publichealth #biotech #drugdevelopment #fda #medicaldevices
Saturday, February 21, 2026, 2:22 am / permalink 19513 / 13 stories in 23 days
FDA formalizes one pivotal trial policy via NEJM perspective / Endpoints
Zachary Brennan / endpoints - Top FDA officials said that a single pivotal trial requirement will be the “new default standard” for drug approvals, a move that goes beyond the agency’s prior discretion around not requiring two trials. In a ...
#healthcare #pharmaceuticals #publichealth #governmentpolicy #biotech #drugdevelopment #fda
Thursday, February 19, 2026, 11:24 am / permalink 19422 / 3 stories in 25 days
F.D.A. Reverses Decision and Agrees to Review Moderna’s Flu Vaccine / NYT
Christina Jewett and Rebecca Robbins / nytimes - Moderna said it had held further discussions with regulators and announced that the agency would accept the company’s application for approval of its flu vaccine that uses mRNA technology.
#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #fda #vaccinesafety
Wednesday, February 18, 2026, 9:23 am / permalink 19353 / 11 stories in 26 days
Ocular Therapeutix Eyes FDA Filing After Wet AMD Drug Tops Regeneron’s Eylea in Phase 3 Test / MedCity
Frank Vinluan / medcitynews - In the first of two Phase 3 tests, Ocular Therapeutix’s Axpaxli met the main goal of helping maintain vision in patients with the wet form of age-related macular degeneration. The Ocular drug was compared to Eylea, a blockbuster wet AMD drug marketed by R…
#healthcare #pharmaceuticals #biotech #drugdevelopment #fda
Tuesday, February 17, 2026, 9:22 pm / permalink 19334 / 3 stories in 26 days
Can medical AI lie? Large study maps how LLMs handle health misinformation / Medical Express
medicalxpress - Medical artificial intelligence (AI) is often described as a way to make patient care safer by helping clinicians manage information. A new study by the Icahn School of Medicine at Mount Sinai and collaborators confronts a critical vulnerability: when a m…
#healthcare #publichealth #governmentpolicy #fda #digitalhealth #medicaldevices
Saturday, February 14, 2026, 3:21 pm / permalink 19202 / 35 stories in 4 wks
Lilly appeals retatrutide classification ruling in case that could impact compounders / Endpoints
Alexis Kramer / endpoints - Eli Lilly is challenging a decision over how the FDA classified its experimental, next-gen obesity shot, in a case that could affect the ability of compounders to rival it. On Thursday, Lilly filed a notice ...
#obesity #healthcare #pharmaceuticals #elililly #weightloss #publichealth #drugdevelopment #fda #digitalhealth
Saturday, February 14, 2026, 12:21 pm / permalink 19191 / 15 stories in 4 wks