FDA+ channel feed – Endpoints News

FDA+ channel feed

Government spending bill tweak means 3 more NDAs will become BLAs, FDA says

6 years ago

FDA staff highlights neurological safety concerns with Durect's pain drug

6 years ago

UK's NICE isn't convinced by Merck's Keytruda in head and neck cancer

6 years ago

‘Clinical superiority’: diazepam nasal spray illustrates FDA parameters for orphan drug exclusivity

6 years ago

Blueprint scores first FDA OK for a precision GIST cancer drug, just ahead of a rival treatment. And the price is a big surprise

6 years ago

Merck's Keytruda wins another first — this time for an FDA nod to treat a subset of bladder cancer patients

6 years ago

'Burner' phones and Ariad secrets: Goldman Sachs banker pleads guilty for his role in global insider trading ring

6 years ago

FDA offers AstraZeneca a shortcut on a landmark SGLT2 approval while China greenlights Lokelma

6 years ago

FDA rushed to approve new drugs in 2019, sometimes way ahead of schedule. Could that be dangerous?

6 years ago

Clinical uncertainty, price pushes UK's NICE to spurn Akcea's Waylivra

6 years ago

China greenlights homegrown pneumococcal, HPV vaccines for the market — breaking grips by Pfizer, Merck

6 years ago

Savara gets FDA breakthrough status despite large, late-stage failure

6 years ago

As Bristol-Myers, Pfizer battle copycat challengers in court, FDA approves generics for blockbuster Eliquis

6 years ago

Intra-Cellular's checkered developmental path ends in schizophrenia approval, shares skyrocket

6 years ago

FDA slams GSK's monthly HIV injectable with CRL, citing manufacturing issues

6 years ago

EMA loses more than 100 staffers in move to Amsterdam

6 years ago

Eisai scores an FDA approval for a homegrown sleep drug

6 years ago

Why wait? The FDA stamps an ultra-fast OK on a HER2+ drug expected to create AstraZeneca's next blockbuster franchise

6 years ago

As Congo Ebola outbreak festers, FDA approves first vaccine to combat deadly virus

6 years ago

FDA drafts guidance on demonstrating substantial evidence of effectiveness

6 years ago

Seattle Genetics gets ready to launch its second ADC after scoring bladder cancer OK with partner Astellas

6 years ago

No OS benefit? No problem. FDA panel backs use of Lynparza in pancreatic cancer

6 years ago

FDA survey finds Americans don’t really understand drug approvals

6 years ago

FDA’s in-house review offers bleak assessment of Epizyme’s tazemetostat — but win or lose this cancer drug may still have a future

6 years ago

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