FDA+ channel feed – Endpoints News

FDA+ channel feed

Checkpoint wins FDA approval of checkpoint inhibitor in advanced skin cancer, seeks partner for launch

5 months ago

Organon's steroid-free cream Vtama wins approval in atopic dermatitis

5 months ago

FDA stands by mifepristone safety label in federal court challenge

5 months ago

EMA's committee says expanded label for Lilly's Mounjaro into sleep apnea not necessary

5 months ago

Safety concerns and trial holds for pediatric RSV vaccines prompt caution from FDA adcomm

5 months ago

'Serious liver injury' cases lead FDA to call for monitoring of Ocaliva patients

5 months ago

During Covid, RFK Jr. lobbied against vaccine EUAs for children. As HHS secretary, he could rescind them

5 months ago

Drugs are approved — and made available — faster in US than most of EU, data show

5 months ago

The Endpoints 100: The biotech industry braces for Trump 2.0

5 months ago

UniQure stock doubles on FDA 'alignment' over accelerated approval for Huntington's drug

5 months ago

Cases of severe RSV in two Moderna vaccine candidates' trials raise questions about future

5 months ago

Supreme Court declines to take PhRMA-Arkansas 340B case

5 months ago

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

5 months ago

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

5 months ago

European Commission greenlights $16.5B Novo-Catalent acquisition

5 months ago

Merus receives FDA accelerated approval to treat NRG1+ cancers

5 months ago

USPTO withdraws proposed patent rule criticized by pharma industry

5 months ago

FDA spells out new expedited withdrawal procedures for accelerated approvals

5 months ago

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

5 months ago

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

5 months ago

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

5 months ago

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

5 months ago

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

5 months ago

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

5 months ago

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