FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA faults Japanese manufacturer with data breach, contaminated injectables

4 years ago

Ascendis wins approval for once-weekly growth hormone drug as Pfizer, Opko Health keep up the pressure

4 years ago

Opinion: Pfizer vaccine's 3-month full approval, and less than 1-month sBLA OK — is the FDA's 'gold standard' evolving?

4 years ago

Days after a CRL and damning reports of trial misconduct, a troubled biotech beats a hasty retreat from Europe

4 years ago

10 ways to reform the FDA's accelerated approval pathway: ICER and MSKCC offer options

4 years ago

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

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