FDA+ channel feed – Endpoints News

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Not so fast: FDA tacks 3 more months onto decision date for Calliditas' rare kidney disorder drug

4 years ago

Once held back, Amylyx execs say the FDA is now pushing for an NDA on ALS drug

4 years ago

Five months after getting slapped with a clinical hold, KalVista gets the OK to restart oral HAE program

4 years ago

Data do not support widespread Covid vaccine boosters right now, outgoing FDA leaders write in the Lancet

4 years ago

FDA head Janet Woodcock raises patent-related concerns to PTO director

4 years ago

Not just the approved indications: FDA to study DTC drug ads that include secondary endpoint data

4 years ago

In a first, FDA warns a researcher for failing to submit data 3 years after trial completion

4 years ago

With industry's blessing, FDA launches novel excipient review pilot program

4 years ago

Food or drug? FDA blasts Flagship-backed microbiome player’s ‘non-IND’ Covid-19 trial

4 years ago

Liver tumors in animals trigger clinical hold for BioMarin gene therapy — highlighting a recurring concern

4 years ago

The long-overlooked safety issue weighing on the FDA’s mind on day 1 of marathon gene therapy meeting

4 years ago

Sister to Juno's liso-cel, JW's relma-cel lands second-ever CAR-T approval in China

4 years ago

'Significant questions remain' on approval of Biogen's new Alzheimer's drug, congressional committees tell FDA

4 years ago

FDA approves BeiGene's Brukinsa in rare blood cancer amid company's US expansion plans

4 years ago

Rulemaking authority restored at FDA as a show of support in a tumultuous time

4 years ago

AbbVie's stock and next megablockbuster take hits following new JAK warnings from FDA

4 years ago

FDA warns of heart-related events, cancer, blood clots, and death for JAK inhibitors

4 years ago

FDA posed a sprawling set of questions for two-day gene therapy hearing. Here's what companies and experts will be watching for

4 years ago

After 2 damning CRLs and 3 denied dispute-resolution requests, an ailing, one-time unicorn has only a glimmer of hope left with the FDA

4 years ago

Expanding on injectable schizophrenia franchise, J&J secures nod for first twice-yearly treatment

4 years ago

Opinion: Time for Biden to explain the political meddling in Covid vaccine reviews

4 years ago

FDA extends full approval for Merck's Keytruda in 1st-line bladder cancer after mixed adcomm vote

4 years ago

In a major blow to vaccine efforts, senior FDA leaders stepping down

4 years ago

Roche pulls dangling accelerated approval for Tecentriq in triple-negative breast cancer

4 years ago

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