FDA+ channel feed – Endpoints News

FDA+ channel feed

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

CEO Ugur Sahin: BioNTech and Pfizer will file for a Covid-19 vaccine EUA on Friday

5 years ago

Amid scrutiny of exec stock sales, SEC chairman echoes calls for 'cooling-off period' in trading plans

5 years ago

Analysts poured cold water, but FDA gives a fast-pass for Sanofi's new Pompe disease drug

5 years ago

Updated: FDA gives Cellectis all clear after patient death halted off-the-shelf CAR-T trial

5 years ago

GSK and ViiV score breakthrough therapy designation in HIV prevention, as Truvada showdown draws nearer

5 years ago

Alkermes is handed a CRL for ‘3831, marking another setback on the R&D front

5 years ago

Penny stock player Adamis gets another CRL for high-dose naloxone as shares crater

5 years ago

Apellis' Soliris rival gets a date at the FDA for a rare blood disorder, with potentially $400M worth of implications

5 years ago

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