FDA+ channel feed – Endpoints News

FDA+ channel feed

Ahead of FDA decision on BTK drug, Amgen-partnered BeiGene is one step closer to China OK for PD-1

6 years ago

FDA to revoke orphan designation for opioid addiction drug Sublocade

6 years ago

Decrying 'arbitrary and capricious' action, RegenxBio sues FDA over clinical holds on gene therapy

6 years ago

HHS is taking Gilead to court, seeking damages for infringing government HIV patents

6 years ago

RegenxBio runs into partial hold for anti-VEGF gene therapy as FDA investigates delivery device

6 years ago

FDA renames and restructures oncology office

6 years ago

Is FDA doing enough to bring biosimilars to market? Experts discuss

6 years ago

Make room for poop transplants, even if a stool-based therapy is eventually approved — insist doctors and patients in FDA hearing

6 years ago

As resistance to standard antibiotics grows, RedHill's H. pylori regimen secures FDA approval

6 years ago

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

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