FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA greenlights label update to Gilead's Biktarvy to include more data in pregnant people

Last year

Sanders presses pharma leaders to change stance on Pandemic Accord proposals

Last year

Updated: FDA approves Pfizer’s hemophilia B gene therapy, with $3.5M price tag

Last year

In rare move, Colombia issues compulsory license for HIV medicine in effort to expand access

Last year

FDA revises guidance on biosimilar promotional labels and advertising

Last year

FDA's biologics chief Peter Marks previews accelerated approval guidance

Last year

Novartis brings Lutathera to adolescents with rare cancer in first for radioligand class

Last year

FDA gives accelerated approval to Day One’s targeted treatment for most common brain tumor in kids

Last year

FDA approves ImmunityBio's bladder cancer therapy combo

Last year

FDA hands CRL to Abeona's rare skin disease cell therapy

Last year

Researchers seek FDA transparency on use of surrogate endpoints outside of oncology

Last year

Takeda wins label expansion for subcutaneous Entyvio, creating 'flexibility' for Crohn's patients

Last year

Califf talks bolstering domestic drug manufacturing, foreign inspections at House hearing

Last year

Lumicell nabs FDA approval for drug-device breast cancer detection system

Last year

Senate bill targeting WuXi won't affect federal spending, CBO says

Last year

FDA hits Natco with warning letter over India facility, suspends product shipments to US

Last year

GAO examines state PBM regulation as Congress weighs wider reforms

Last year

New FDA trial innovation center launches with demonstration to increase industry interactions

Last year

FDA is ready to eliminate the interchangeability designation for biosimilars

Last year

Adcomm backs use of minimal residual disease in multiple myeloma accelerated approvals

Last year

EMA probe finds no causal link between semaglutide and suicidal thoughts, self-harm

Last year

FDA commissioner calls on House committee to help combat drug shortages

Last year

AstraZeneca's Fasenra expands approval in children with severe asthma

Last year

CMS to increase reimbursement for new sickle cell gene therapies

Last year

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