FDA+ channel feed – Endpoints News

FDA+ channel feed

Safety risk pushes FDA to cut off J&J's Covid-19 vaccine with some limited exceptions

4 years ago

BioCryst officially gets partial clinical hold on lead candidate after halting enrollment

4 years ago

Enhertu wins another breast cancer approval, as AstraZeneca and Daiichi Sankyo prepare to corner the market

4 years ago

Former FDA chief of staff steps into VP role at Philip Morris as CDMO pivot continues

4 years ago

AstraZeneca poised to snag fast approval for a frontline use of Imfinzi, adding to its growing oncology portfolio

4 years ago

FDA releases second Pfizer gene therapy from clinical hold, as hemophilia program gets OK to restart

4 years ago

Takeda GI spinout nabs approval for only drug — and pivots to a quick raise

4 years ago

FDA hits Miami University in Ohio with a warning letter over falsified data

4 years ago

FDA leaders in JAMA: This fall will kick off the 'new normal' of annual Covid-19 boosters

4 years ago

A year after CRL, Acadia is going back to bat for Nuplazid at the FDA

4 years ago

FDA guidance machine churns out 8 new documents in less than a week

4 years ago

FDA hits Hutchmed, Junshi drugs with CRLs — further clarifying its stance on China-only data

4 years ago

Axsome's migraine drug issued CRL a week after the biotech outlined CMC concerns

4 years ago

FDA puts a hold on Vertex’s attempted diabetes cure

4 years ago

Under pressure? FDA pencils in June review dates for Pfizer, Moderna Covid vaccines for kids, plus Novavax EUA

4 years ago

FDA tells Praxis it can't move into the clinic just yet for a rare epilepsy drug

4 years ago

FDA lifts hold on Finch’s microbiome crapsule, as company looks to right ship

4 years ago

Senators grill Califf over proposed FDA budget as commissioner lays out 2023 priorities

4 years ago

FDA proposes adding 'race and ethnicity' category to expanded access requests

4 years ago

Fennec looks for FDA approval for hearing loss drug haunted by manufacturing problems

4 years ago

CDER director on accelerated approval reforms and a court decision that will 'send a chill' across rare disease drug development

4 years ago

CRL appeal lands Ardelyx an FDA adcomm meeting for embattled CKD drug

4 years ago

Axsome expects migraine drug to be rejected as manufacturing issues arise

4 years ago

FDA warns small biotech Ocugen of potential $10K fines for failing to post trial results

4 years ago

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