FDA+ channel feed – Endpoints News

FDA+ channel feed

Advocacy group accuses FDA neuro chief Billy Dunn of misconduct in controversial Biogen review, demands a purge and federal probe

5 years ago

AstraZeneca's vaccine hit its first roadblock with Indian regulators. Will lingering doubts derail its plans elsewhere?

5 years ago

Beating Merck, Pfizer gets priority review as the first Prevnar follow-up heads to the FDA

5 years ago

AstraZeneca publishes interim vaccine data in Lancet, reveals 10 hospitalizations, 1 death in pivotal control arms

5 years ago

FDA internal review points to imminent Pfizer/BioNTech EUA, spotlights potential for single-dose vaccination

5 years ago

A KRAS drug is likely coming — fast — as the FDA points Amgen’s frontrunner to a looming finish line

5 years ago

An FDA inspection raises questions about Bristol Myers Squibb's liso-cel facility and the CVR, but analysts urge caution

5 years ago

FDA turns scPharmaceuticals and its drug-device for edema away a second time

5 years ago

Amid a record bad year, Bellicum keeps taking its lumps as FDA slams trial hold on CAR-T hopeful

5 years ago

FDA hits ALX Oncology with partial clinical hold, capping PhII studies at 50 patients while safety check ensues

5 years ago

J&J guns for quick drug OK in lung cancer niche, taking the first step challenging AstraZeneca in EGFR

5 years ago

BioCryst wins approval for HAE pill and charges half-a-million dollars, but will anyone take it?

5 years ago

Roche turns up the heat on Lilly with another Gavreto approval, elbowing its way into the thyroid cancer space

5 years ago

UK grants Pfizer, BioNTech historic first OK for mRNA vaccine, expects millions of doses by year end

5 years ago

BridgeBio grabs a second priority review for the portfolio — giving Perceptive startup cause to celebrate

5 years ago

The FDA spells out 4 reasons why it hates Minerva’s NDA ideas — but the biotech is going for it anyway

5 years ago

Several weeks after getting hit with an RTF, Y-mAbs lands approval for its other neuroblastoma candidate

5 years ago

FDA gives Rhythm the green light for setmelanotide, a drug aimed at reducing obesity in certain genetic disorders

5 years ago

FDA hands Liquidia and Revance a CRL and deferral, respectively, as Covid-19 creates inspection challenge

5 years ago

The aducanumab conundrum: The PhIII failed a clear regulatory standard, but no one is certain what that means anymore at the FDA

5 years ago

Roche tacks on another Xofluza indication as flu season meets pandemic

5 years ago

Alnylam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

5 years ago

Eiger nabs the first FDA approval for Progeria, an ultra-rare premature aging disease, with an old Merck drug

5 years ago

Trailing Eli Lilly by 12 days, Regeneron gets the FDA OK for their Covid-19 antibody cocktail

5 years ago

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