FDA+ channel feed – Endpoints News

FDA+ channel feed

Damn the critics, Biogen CEO Vounatsos orders full speed ahead on prepping a controversial aducanumab launch as FDA decision looms

5 years ago

Law professors call for FDA to disclose all safety and efficacy data for drugs

5 years ago

Why remote drug manufacturing evaluations won't really reduce FDA's backlog of inspections

5 years ago

FDA offers scathing review of Emergent plant's sanitary conditions, employee training after halting production

5 years ago

House Democrats call on Emergent execs to testify on quality issues next month

5 years ago

Opinion: US and EU reviews of blood clots and J&J’s Covid vaccine show why a transparent process matters

5 years ago

J&J to restart Covid vaccine shipments to Europe as EMA adds safety warning over rare blood clots

5 years ago

Amgen's promising gastric cancer drug makes good on Five Prime potential with FDA's breakthrough nod

5 years ago

FDA slaps a hold on KalVista's PhII study of an HAE drug, raising a red flag on preclinical results

5 years ago

FDA slaps a hold on Moffitt’s next-gen CAR-T as regulators demand another delay on clinical work — shares crater

5 years ago

When is a drug really a device? Court knocks down FDA appeal in trying to sort that grey area

5 years ago

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

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