FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA revokes EUA for Eli Lilly Covid-19 treatment

5 years ago

PDUFA VII to expand FDA’s real-time oncology reviews to supplements for all therapeutic areas

5 years ago

Sponsors should flag decentralized aspects of cancer trials to prep for the post-Covid era, FDA says

5 years ago

Exclusive interview: Peter Marks on why full Covid-19 vaccine approvals could be just months away

5 years ago

Janet Woodcock on if the FDA is getting tougher on drug reviews: ‘I don’t think so’

5 years ago

Former head of FDA’s medical and scientific affairs on Covid: ‘FDA has never been tested like this’

5 years ago

Fifth Circuit sides with FTC in major pay-for-delay settlement case

5 years ago

Opinion: Biden needs to step up and nominate an FDA commissioner

5 years ago

FDA dispenses with in-person requirement for abortion pill access during the pandemic

5 years ago

J&J pauses vaccine rollout as feds probe rare cases of blood clots

5 years ago

Patrizia Cavazzoni named permanent director of CDER, adding to questions around where Woodcock will end up

5 years ago

Gene therapies for neurodegenerative diseases: Pfizer, Novartis, Biogen and others seek more from FDA

5 years ago

EMA investigating 4 'serious cases' of blood clots following J&J vaccinations

5 years ago

CBO: Congressional action on drug prices will make R&D spending less attractive

5 years ago

Scoop: Ferring, Blackstone’s $570M gene therapy venture has imploded after CMC issues stymied a once high-profile quest

5 years ago

Trouble brewing for Provention? Shares crater after FDA says their teplizumab drug profile doesn't match that from former owner Eli Lilly

5 years ago

FDA inspection of Emergent’s Baltimore site in 2020 raises new questions

5 years ago

Series of JAK inhibitor delays may signal an upcoming FDA adcomm

5 years ago

Former Indivior medical lead who pled guilty to false opioid marketing now seeks FDA hearing to escape debarment

5 years ago

Recall report: A-S pulls nearly 200,000 acetaminophen bottles off shelves; Apotex yanks ADHD med

5 years ago

PDUFA VII negotiations near finish line with plans to revamp CBER and staff up

5 years ago

Eyeing standard of care status in 3rd-line TNBC, Gilead nails down full OK for Trodelvy with a slightly broader label

5 years ago

EMA finds link between ‘very rare’ but sometimes fatal blood clots and AstraZeneca vaccine

5 years ago

FDA and EMA signal an opportunity to harmonize advanced therapy regulations

5 years ago

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