FDA+ channel feed – Endpoints News

FDA+ channel feed

Alzheimer's stunner: Chinese biotech wins OK for a new drug on positive data — and they have some high-profile supporters

6 years ago

Data suggest gene, cell therapy trial initiations in Europe lag behind North America — here's why

6 years ago

Novartis admits to ‘mistake’ after partial clinical hold placed on Zolgensma trial

6 years ago

FDA to require certain IND safety reports be submitted to FAERS

6 years ago

Novartis takes a hit as FDA orders a hold on Zolgensma trials in wake of fresh safety concerns

6 years ago

FDA experts vote to yank the agency's 2011 OK of controversial preterm birth drug after a trial failure

6 years ago

FDA drafts guidance on Type V DMFs for combination products

6 years ago

Roche — surprise — delays $4.3B Spark buyout again as regulators hover

6 years ago

FDA backs Mike Grey's bet on a comeback drug play with breakthrough status for maralixibat

6 years ago

Allergan ties up Namenda loose ends with $750M settlement

6 years ago

FDA revises guidance on postmarketing studies to reflect ARIA system, SUPPORT act

6 years ago

FTC staff signs off on Roche $4.3B deal for Spark — report

6 years ago

Vertex finally makes NICE with England's NHS on CF therapies, but runs into hiccup with preclinical kidney drug data

6 years ago

As clock ticks, Trump will nominate Stephen Hahn as FDA commissioner next week — report

6 years ago

Bristol-Myers makes Opdivo pitch for frontline lung cancer with open label PhIII study

6 years ago

Where are the interchangeable biosimilars?

6 years ago

FDA rebuffs little Assertio Therapeutics' long-acting ACTH formulation, shares sink

6 years ago

The FDA sets a regulatory speed record, providing a snap OK for Vertex's breakthrough triplet for cystic fibrosis

6 years ago

J&J's blockbuster Stelara wins US approval for ulcerative colitis

6 years ago

AstraZeneca's Farxiga scores FDA nod to cut risk of hospitalization for heart failure in diabetics

6 years ago

EMA backs seven therapies, including Merck's Ebola vaccine

6 years ago

As Osiris moves on from fraudulent past, one exec settles up with SEC

6 years ago

J&J's Xarelto, Amarin's Vascepa are cost-effective, not budget friendly — ICER

6 years ago

Another record year for generic drug approvals but questions on competition remain

6 years ago

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