FDA+ channel feed – Endpoints News

FDA+ channel feed

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

FDA open to use of new MRD endpoint ahead of advisory committee meeting

Last year

Endo sues FDA over its handling of generic Adrenalin approvals

Last year

Exclusive: Top lobbyist at BIO leaves as trade group grapples with US-China tensions

Last year

Novartis, Sanofi and PhRMA push FDA on how to better handle complex trial designs

Last year

Virginia governor vetoes bill to create advisory board to reduce drug prices

Last year

Indian pharma receives FDA warning letter for barefoot employees and general 'disrepair'

Last year

BrainStorm outlines plans for what may be final attempt to bring ALS drug to market

Last year

FDA officials raise concerns with immunotherapy overuse for early-stage cancer patients: #AACR24

Last year

Nearly half of cancer drugs granted accelerated approval didn’t end up showing clinical benefit — study

Last year

Stealth Bio gets FDA adcomm for previously rejected ultra-rare disease drug

Last year

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