FDA+ channel feed – Endpoints News

FDA+ channel feed

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

With pipeline setbacks mounting, United snares priority voucher for inhaled formulation of PAH med Tyvaso

5 years ago

Groups seek clarity on interchangeability in BsUFA III

5 years ago

Vivek Ramaswamy's 'vant' brainchildren keep bearing fruit with Urovant's FDA nod for incontinence med vibegron

5 years ago

Altimmune shares slide as the FDA flashes a red light for the IND work on their intranasal Covid-19 vaccine

5 years ago

FDA slaps a hold on Voyager's lead gene therapy over 'MRI abnormalities'

5 years ago

FDA greenlights second Ebola treatment in three months, handing new OK to Ridgeback's Ebanga

5 years ago

The FDA slaps a hold on uniQure's hemophilia B gene therapy as researchers explore a case of liver cancer in latest setback for a booming field

5 years ago

Best-selling Tagrisso further outpaces an upcoming J&J rival, winning approval in new NSCLC indication

5 years ago

It's a big day for Moderna — and the world — as the FDA stamps an EUA on their vaccine. And there are some important lessons to remember

5 years ago

FDA unexpectedly delays roxa decision, foiling FibroGen's February rollout plans

5 years ago

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