FDA+ channel feed – Endpoints News

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To lead NIH, Trump taps Stanford academic and pandemic response critic Jay Bhattacharya

5 months ago

The Biden administration wants Medicare and Medicaid to cover GLP-1s. Will the Trump White House allow it?

5 months ago

Axsome moves toward NDA filing for narcolepsy drug following positive Phase 3 data

5 months ago

Soleno’s rare pediatric disease drug faces PDUFA delay by three months

5 months ago

Trump team asked Warp Speed leader to head NIH, may seek more traditional pick for role

5 months ago

For CDC, Trump picks Dave Weldon, a former congressman who pushed for vaccine injury claims

5 months ago

Trump taps Johns Hopkins researcher Marty Makary to lead the FDA; also names CDC, surgeon general picks

5 months ago

FDA approves BridgeBio's heart disease drug, setting up competition with Pfizer, Alnylam

5 months ago

FDA adcomm raises risk questions on AstraZeneca’s Andexxa

5 months ago

Jazz wins approval for bispecific in biliary tract cancer

5 months ago

FDA updates label of 33-year-old cancer drug with new dose and warning

5 months ago

When generative AI meets the FDA: First digital health adcomm kicks off discussion

5 months ago

GSK plots regulatory filings for PBC itch after positive Phase 3 readout

5 months ago

FDA rejects Astellas’ effort to support longer use of eye drug Izervay

5 months ago

Ahead of adcomm, FDA raises safety questions for AstraZeneca’s reversal agent for life-threatening bleeds

5 months ago

Chinese drugmaker receives FDA warning letter after management hindered inspection

5 months ago

Syndax's Revuforj wins FDA approval in aggressive form of leukemia

5 months ago

FDA offers more guidance on developing cell and gene therapies

5 months ago

Post-Hoc: RFK vs. Vivek, and the future of US drug policy

5 months ago

Eli Lilly sues the US government over its proposed 340B rebate model

5 months ago

Trump picks vaccine skeptic Kennedy to lead HHS, in what would be an upheaval of US health policy

5 months ago

European drug regulator reverses opinion on Eisai and Biogen's Alzheimer's drug

5 months ago

FDA approves PTC’s ultra-rare disease gene therapy for broader patient population than Europe

5 months ago

Drug inspector attrition leads to 'many fewer' checks than 2016 peak, GAO says

5 months ago

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