FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA greenlights Orchard's gene therapy Lenmeldy for rare and fatal disease

Last year

Updated: FDA adcomm backs benefits of Abecma and Carvykti in earlier patients

Last year

Bristol Myers scores accelerated approval in more blood cancers for CAR-T therapy Breyanzi

Last year

FDA lays out cross-agency efforts on regulating AI in medical products

Last year

After years of delay, BeiGene finally lands FDA approval for its PD-1 drug

Last year

FDA adcomm votes in favor of Geron's anemia drug for cancer patients despite questions on risk

Last year

FDA approves Madrigal’s NASH drug, marking the first-ever treatment for the liver disease

Last year

Lawmakers amp up calls for PBM reforms to be included in next week's funding package

Last year

Mirum expands label for rare liver disease drug, serving up more competition for Ipsen's Bylvay

Last year

FDA raises concerns of 'early deaths' in Abecma and Carvykti multiple myeloma trials

Last year

FDA challenges safety, efficacy of Geron's imetelstat ahead of advisory committee meeting

Last year

US spent $3B on DMD treatments as confirmatory studies still underway, JAMA paper says

Last year

Biden administration proposes funding bump for FDA, nixing interchangeability requirement

Last year

FDA puts added emphasis on amyloid in update on Alzheimer's R&D guidance

Last year

Viatris and Mapi evaluate next steps after FDA rejects long-acting MS injection

Last year

Pharma bristles at Biden’s call to expand IRA negotiations at State of the Union

Last year

Updated: FDA approves weight loss drug Wegovy to reduce cardiovascular events

Last year

The FDA almost never pulls fully-approved drugs. Amylyx's ALS treatment might be the exception

Last year

In surprise move, FDA delays decision on Lilly’s Alzheimer’s drug, will convene advisory committee

Last year

BeiGene’s Brukinsa bags fifth FDA approval, likely positioning it for continued sales growth

Last year

Bristol Myers nabs approval for Opdivo combo as first-line bladder cancer treatment

Last year

FDA sees success in model-informed drug development pilot

Last year

Valisure pressures FDA to recall acne treatments after finding carcinogen

Last year

FDA faces flatlined budget as clock ticks for Congress to pass government funding

Last year

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