FDA+ channel feed – Endpoints News

FDA+ channel feed

Covid-19 claims another PDUFA victim as GlaxoSmithKline pushes back planned PD-1 rollout

5 years ago

Merck makes good on big CV gamble with vericiguat nod — but competition will be fierce

5 years ago

HHS, FDA dispute spills out onto Twitter

5 years ago

AstraZeneca keeps the ball rolling on Daiichi-partnered Enhertu, picking up 2nd indication in gastric cancer

5 years ago

Poll: Should Joshua Sharfstein or Janet Woodcock lead the FDA from here?

5 years ago

Janet Woodcock is in the running for FDA commissioner — what does that mean for the agency's future?

5 years ago

Industry, FDA begin to hammer out PDUFA VII details

5 years ago

Novartis gets breakthrough designation for Xolair successor, setting up spotlight for PhIII readout later this year

5 years ago

Janet Woodcock to be acting FDA commissioner while Biden team finalizes nominee — reports

5 years ago

Bayer wins priority review for CKD program finerenone after PhIII data showed a delay in disease progression

5 years ago

Merck snags priority review for Prevnar 13 rival — just one month after Pfizer sent its follow-on to the FDA

5 years ago

Trump's HHS continues to assert authority over FDA in twilight of his presidency, implementing new drug timeline rules

5 years ago

Editas Medicine's science head Albright leaves for new job just as biotech gets trial clearance for sickle cell therapy

5 years ago

Boehringer Ingelheim permanently shelves production of clonidine, citing earlier recall and market competitors

5 years ago

Recall report: Fresenius Kabi yanks inflammatory med Ketorolac after finding particulates in vials

5 years ago

FDA sideswipes Neoleukin with clinical hold on lead immunotherapy candidate, sends shares plummeting

5 years ago

FDA offers first thoughts on neurodegenerative disease gene therapies

5 years ago

AstraZeneca's Farxiga gets rough FDA review date for groundbreaking move into chronic kidney disease

5 years ago

'N of 1' therapies addressed in draft FDA guidance

5 years ago

Roche gets a leg up in the anti-TIGIT race with first breakthrough designation for PhII winner tiragolumab

5 years ago

Recall report: Nostrum expands recall of diabetes drug metformin after carcinogen concerns

5 years ago

Bristol Myers Squibb walks on Opdivo's FDA nod for small-cell lung cancer after middling OS data couldn't back approval

5 years ago

AstraZeneca/Oxford score first vote of confidence as UK authorizes their Covid-19 vaccine

5 years ago

FDA lifts clinical hold on Audentes' gene therapy program after three patient deaths triggered alarms

5 years ago

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