FDA+ channel feed – Endpoints News

FDA+ channel feed

Moderna wraps its BLA for their megablockbuster Covid vaccine. Chances are you won't have to wait long on the FDA

4 years ago

Rare disease drugmaker files for approval despite objections from FDA on adequate trial data

4 years ago

EC approves AbbVie's upadacitinib as first JAK inhibitor for atopic dermatitis

4 years ago

Next user fee deal reveals where industry won at the negotiating table with FDA

4 years ago

Cara, Vifor Pharma score speedy FDA nod on itching drug for CKD — shares surge

4 years ago

PDUFA VII: What's new, and what's significant in the next user fee deal

4 years ago

Capping AAV dose? Tweaking gene therapy trials? New animal models? FDA poses far-reaching questions for experts

4 years ago

Gilead, Regeneron, AstraZeneca and more encourage FDA to expand patient reported outcome guidance

4 years ago

Pfizer earns long-awaited full FDA nod for Covid-19 vaccine, a hopeful aid in US campaign

4 years ago

Delaying the inevitable? Axsome says FDA review going beyond PDUFA date

4 years ago

While figuring out post-CRL future for roxadustat, FibroGen celebrates Europe OK with Astellas

4 years ago

FDA grants hearing to discuss withdrawal of contentious preterm birth drug Makena

4 years ago

The heart failure market gets a little more crowded, as Eli Lilly and Boehringer Ingelheim score a win for Jardiance

4 years ago

FDA+ roundup: New untitled letter for web ads without risk info; PANDAs and regulatory uncertainty

4 years ago

Still reeling from Zejula setback, GlaxoSmithKline gets a breather with expanded PD-1 approval

4 years ago

FDA lifts clinical hold on Rocket's gene therapy for heart failure after 3-month delay

4 years ago

Pfizer, US Army nab a new approval for a decades-old vaccine

4 years ago

FDA rejects Sesen Bio's bladder cancer pitch, sending shares spiraling back to penny stock territory

4 years ago

Merck takes home an FDA win for a Roger Perlmutter favorite, potentially cracking open big market

4 years ago

Vifor blasts FDA's 'reckless' renaming of 4 drugs under the same molecule moniker

4 years ago

New drug application filings with FDA to cost more than $3M for first time ever in 2022

4 years ago

Jazz earns expanded approval for drug with controversial history, prompting expert pushback

4 years ago

Ipsen withdraws NDA for rare bone disease treatment less than 3 months after winning priority review

4 years ago

Long-time FDA leader Ellis Unger exits as exodus of high-ranking officials continues

4 years ago

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