FDA+ channel feed – Endpoints News

FDA+ channel feed

Lilly drops body mass ranges from FDA label for weight loss drug

5 months ago

Eli Lilly, Pfizer stress independence of telehealth partners in response to senators

5 months ago

Applied Therapeutics gets FDA warning letter over study of rejected rare disease drug

5 months ago

FDA defends increased use of guidance in new report to Congress

5 months ago

J&J looks to expand Tremfya in two pediatric indications

5 months ago

Scott Gottlieb says he’s against RFK Jr. for HHS: ‘It will cost lives in this country’

5 months ago

Biocon lands FDA approval for another Stelara biosimilar

5 months ago

Applied Therapeutics' rare disease drug gets a CRL

6 months ago

FDA is looking into hematology risks after patients take bluebird's Skysona gene therapy

6 months ago

PTC reports Phase 2 ALS fail, sells priority review voucher for $150M

6 months ago

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

6 months ago

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

6 months ago

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

6 months ago

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

6 months ago

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

6 months ago

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

6 months ago

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

6 months ago

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

6 months ago

FDA adcomm raises risk questions on AstraZeneca’s Andexxa

6 months ago

Jazz wins approval for bispecific in biliary tract cancer

6 months ago

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

6 months ago

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

6 months ago

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

6 months ago

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

6 months ago

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