FDA+ channel feed – Endpoints News

FDA+ channel feed

Agios' stock drops after disclosing new liver-related safety warning in filing to FDA

7 months ago

Biosecure bill is left out of end-of-year defense package, dealing blow to chances

7 months ago

European Commission greenlights $16.5B Novo-Catalent acquisition

7 months ago

Merus receives FDA accelerated approval to treat NRG1+ cancers

7 months ago

USPTO withdraws proposed patent rule criticized by pharma industry

7 months ago

FDA spells out new expedited withdrawal procedures for accelerated approvals

7 months ago

Imfinzi snags another FDA nod to treat lung cancer, this time for limited-stage SCLC

7 months ago

Biosecure compromise could add executive review process for named companies, sources say

7 months ago

Moderna CEO defends pandemic prep efforts with critics set to enter Trump’s administration

7 months ago

Trade group tells FDA that semaglutide is not too 'complex' for compounding

7 months ago

Bluebird and Vertex's sickle cell gene therapies to kick off new Medicaid access model

7 months ago

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

7 months ago

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

7 months ago

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

7 months ago

FDA defends increased use of guidance in new report to Congress

7 months ago

J&J looks to expand Tremfya in two pediatric indications

7 months ago

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

7 months ago

Biocon lands FDA approval for another Stelara biosimilar

7 months ago

Applied Therapeutics' rare disease drug gets a CRL

7 months ago

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

7 months ago

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

7 months ago

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

7 months ago

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

7 months ago

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

7 months ago

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