FDA+ channel feed – Endpoints News

FDA+ channel feed

Developing gene therapies for neurodegenerative diseases: FDA finalizes guidance

3 years ago

CD28 kills again? Mitch Gold’s plan to make cell therapy 2.0 history crashes after another patient dies of cardiogenic shock

3 years ago

Updated: After long slog, AstraZeneca finally gets CTLA-4 drug over finish line

3 years ago

Bristol Myers lines up a date with the FDA to expand the footprint of its $13B heart drug

3 years ago

How to avoid false conclusions: FDA finalizes long-awaited guidance on multiple endpoints in clinical trials

3 years ago

New Torrent Pharmaceuticals Form 483 highlights cleaning and other quality issues

3 years ago

Unsanitary conditions and other QC issues raised by FDA in a warning to contract packager

3 years ago

FDA adcomm again votes to pull controversial pre-term birth drug from the market

3 years ago

FDA commissioner on accelerated approval reforms: 'Need to address as soon as possible'

3 years ago

Updated: In new speed bump for Huntington's, FDA pauses PTC's PhII trial

3 years ago

Tissue-agnostic drug development: FDA oncology center offers draft guidance

3 years ago

Senators call on NIH to take action on slow-to-report clinical trial sponsors

3 years ago

Top CDER leaders rake Covis over the coals on its failed confirmatory trial, negative data

3 years ago

FDA delays Biogen's ALS drug review by three months, decision to now come next April

3 years ago

FDA spurns Minerva’s schizophrenia drug in RTF, sending share price into tailspin

3 years ago

Ensuring consistency in product quality: How FDA's requests for more info will be formalized

3 years ago

FDA punts Travere's rare kidney disease NDA for three months, requesting REMS update

3 years ago

FDA settles drug compounding suit, agrees to speed its review of bulk ingredients

3 years ago

FDA signs off on GSK label expansion for Tdap vaccine

3 years ago

FDA reveals QC issues at Eli Lilly’s manufacturing site in New Jersey — report

3 years ago

CDER strikes back at Vanda, discloses rationale behind 2019 sNDA rejection

3 years ago

Senate Republicans seek to repeal new government drug price negotiations

3 years ago

FDA spurns Supernus for Parkinson's drug, noting application issues 'across several areas'

3 years ago

After two CRLs, FDA approves scPharmaceuticals' drug-device as biotech nabs $100M to fund launch

3 years ago

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