FDA+ channel feed – Endpoints News

FDA+ channel feed

Merck's pneumococcal vaccine suffers PDUFA delay in pediatric population, with Pfizer hot on its tail

4 years ago

FDA chief Rob Califf: The business of health is booming but people's outcomes aren't improving

4 years ago

Cancer drug developers will learn from the blazing speed of the Covid-19 vaccine race, FDA leaders say

4 years ago

After an RTF and some stern warnings, FDA slaps CytoDyn with two clinical holds

4 years ago

FDA advisors vote 6-4 against Amylyx's ALS drug, further dimming its hope for regulatory success

4 years ago

Safety concerns lead FDA to reject Akebia's kidney drug

4 years ago

Fed watchdog confirms Trump-era Covid ad campaign shenanigans — and millions misspent

4 years ago

Biden likely to sign a bill that would crack down on China's chokehold on the antibiotic supply

4 years ago

FDA calls for Hatch-Waxman tweak, accelerated approval reforms in President Biden's 2023 budget proposal

4 years ago

Amylyx shares routed on skeptical adcomm docs — but did the FDA leave an open door on unmet ALS need?

4 years ago

UCB lands FDA approval in newest indication for newly-acquired Zogenix epilepsy drug

4 years ago

Paul Hudson's rare disease pivot takes a small step forward, as Niemann-Pick drug wins Japan approval

4 years ago

EMA OKs two new drugs — J&J's BCMA CAR-T for multiple myeloma, AstraZeneca's Evusheld — plus 5 label expansions

4 years ago

Intarcia may finally get its post-CRL review, although FDA points to Covid and another hearing as taking priority

4 years ago

No more accelerated approvals for PI3K? Biotech cites FDA's 'current position' as it warns of major delay

4 years ago

With competitors circling, ViiV wins another label update for long-acting HIV injectable Cabenuva

4 years ago

FDA serves up a quick rejection of China-only data with a CRL for Lilly's PD-1

4 years ago

Novartis' radiopharma drug wins approval in tough-to-treat prostate cancer patients

4 years ago

Ahead of FDA committee to discuss new ALS drug, the jury remains out on how much benefit is enough for approval

4 years ago

FDA forced to reset how it regulates some ophthalmic drugs following court loss

4 years ago

With latest Keytruda OK, Merck edges into GlaxoSmithKline’s (small) PD-1 turf

4 years ago

Cadila's sterile injectable site in India hit with a Form 483 following a rare international inspection for FDA

4 years ago

Marinus completes its turnaround with first approval of sole drug, winning a PRV for its efforts

4 years ago

Accelerated approval reforms take center stage at House hearing, but a way forward remains unclear

4 years ago

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