FDA+ channel feed – Endpoints News

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Sanofi's sleeping sickness drug wins FDA OK and a lucrative priority review voucher too

4 years ago

New study shows smaller biopharma companies struggle more than larger ones with clinical trial transparency

4 years ago

Albireo caps a big week with back-to-back approvals in the US/EU for the first drug to treat a severe liver disease

4 years ago

FDA rejects professor’s petition seeking to pull ‘dangerous’ Otsuka kidney disease drug

4 years ago

Industry groups warn of drug shortages linked to widespread carcinogen testing as FDA doubles down on its approach

4 years ago

Ardelyx craters after FDA stuns analysts and rejects their kidney disease pitch

4 years ago

FDA’s domestic biopharma inspections return to normal as agency faces backlog of 8,000+

4 years ago

Merck crosses the finish line with its next-gen pneumococcal vaccine. Does it stand a chance against Pfizer's 20-valent shot?

4 years ago

Kadmon bags a quick win for its graft-versus-host disease drug ahead of August PDUFA date

4 years ago

FDA supports limited distribution of antismoking drug Chantix despite carcinogen risk

4 years ago

Safety concerns push FDA adcomm to vote overwhelmingly against approval for FibroGen anemia drug

4 years ago

As investigations mount and controversy swirls, Biogen fights back against ICER — and then faces another unanimous slapdown

4 years ago

Major health systems refuse to administer Aduhelm as top FDA leaders meet behind closed doors to talk with payers

4 years ago

FDA chides Amgen over misleading banner ad for Neulasta

4 years ago

Private insurers decline to cover Biogen's new Alzheimer's drug in escalating standoff — report

4 years ago

FDA mulls regulatory action on Sprout's 'female Viagra' after adverse events spike

4 years ago

EU set to launch full-scale investigation into Grail-Illumina deal amid antitrust concerns — report

4 years ago

Cornered by critics, top FDA officials stand by Aduhelm OK amid calls to reform accelerated approval process

4 years ago

FDA raises safety, efficacy questions for FibroGen's anemia drug roxadustat with adcomm on the horizon

4 years ago

Biden executive order lifts ban on using march-in rights to lower drug costs

4 years ago

House committees kick off investigation into how Biogen's Aduhelm won approval

4 years ago

Zantac manufacturers off the hook after judge dismisses negligence and failure-to-warn claims in class-action lawsuit

4 years ago

FDA adds second warning to J&J's Covid-19 vaccine on data linking it to rare nerve condition

4 years ago

In multiple myeloma showdown, J&J adds another feather to Darzalex's cap

4 years ago

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