FDA+ channel feed – Endpoints News

FDA+ channel feed

Merck asks EMA to reevaluate rejected Covid-19 antiviral

3 years ago

FDA pauses Mersana’s clinical trial after patient dies

3 years ago

Calliditas plans to file for full approval for rare kidney disease drug following PhIII data

3 years ago

Updated: Acadia wins first FDA approval for Rett syndrome drug

3 years ago

Republican senators slam proposed accelerated approval payment reforms

3 years ago

FDA will phase out 22 Covid-19 guidance documents as emergency declaration expires

3 years ago

FDA schedules adcomms for Entasis' antimicrobial treatment, Intercept's NASH hopeful

3 years ago

GAO to FDA: Do more to encourage drug manufacturing innovation

3 years ago

Pfizer's migraine nasal spray from Biohaven notches approval

3 years ago

Vertex heads to the clinic with a next-gen stem cell candidate for type 1 diabetes

3 years ago

FDA adcomm votes 11-2 to expand Roche's Polivy label in DLBCL

3 years ago

Biden budget wants to more than double number of negotiated drugs under Medicare, and eliminate hepatitis C

3 years ago

FDA makes rare 'misinformation' comment on Lucira's EUA for its at-home Covid-19 and flu test

3 years ago

Simultaneous advice from FDA and EMA? Very few companies go that route with new drugs, review finds

3 years ago

Apotex issues recall of eye treatment over cracked bottle caps

3 years ago

FDA raises questions in adcomm briefing docs for Roche's Polivy label expansion

3 years ago

FDA inspection uncovers cherry-colored antibiotic residue on equipment at Teva's New Jersey site

3 years ago

FDA says no adcomm planned for Biogen, Sage's depression drug

3 years ago

Mesoblast’s aGVHD cell therapy will get another shot at the FDA

3 years ago

Makena saga nears an end as Covis requests to pull controversial preterm birth drug

3 years ago

Where are all the generic inhalers for asthma and COPD? Researchers call for patent and FDA reforms

3 years ago

Rare disease trials can't find enough patients. It's forcing the FDA to rethink its approach

3 years ago

Biden proposes extending Medicare price negotiations to more drugs

3 years ago

FDA delays review of BioMarin's hemophilia gene therapy after data update

3 years ago

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