FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA outlines product development process to combat Wuhan coronavirus

6 years ago

What in the world is a MINOR CRL, Amphastar?

6 years ago

The FTC and New York state accuse Martin Shkreli of running a drug monopoly. They plan to squash it — and permanently exile him

6 years ago

Drug-drug interactions: FDA issues guidance on clinical, in vitro studies

6 years ago

FDA waves Epizyme's $186K rare cancer drug through to market — now get ready for the second act

6 years ago

The FDA has devalued the gold standard on R&D. And that threatens everyone in drug development

6 years ago

NICE stays sour on AstraZeneca's Tagrisso

6 years ago

FDA’s golodirsen CRL: Sarepta’s Duchenne drugs are dangerous to patients, offering only a small benefit. And where's that confirmatory trial?

6 years ago

FDA hands off its latest whirlwind drug OK as Horizon hustles would-be blockbuster to the market

6 years ago

FDA to allow online submissions of orphan designation requests

6 years ago

Germany’s IQWiG finds first tumor-agnostic drug provides no added benefit

6 years ago

Hung jury vote leaves FDA with a difficult decision on Durect's non-opioid painkiller

6 years ago

The FDA: Faster, but not necessarily better. And that could threaten the agency's brand

6 years ago

Biopharma's China plan gets a boost from patent protections sealed in now official trade deal

6 years ago

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

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