FDA+ channel feed – Endpoints News

FDA+ channel feed

Four years in, Sana gets first FDA go-ahead to bring cancer treatment into the clinic

3 years ago

FDA advisory committee votes unanimously in favor of bivalent Covid shots replacing primary series

3 years ago

FDA reports initial 'no signal' for stroke risk with Pfizer boosters, launches concomitant flu shot study

3 years ago

FDA cuts off use for AstraZeneca’s Covid-19 therapy Evusheld

3 years ago

FDA takes next step in Torrent Pharmaceuticals' troubled India plant saga, issues OAI

3 years ago

FDA sends warning letter to community hospital review board over research concerns

3 years ago

EMA changes orphan designation policy for certain eye drugs to expand access

3 years ago

ODAC to debate Roche's Polivy in first-line DLBCL following 2019 accelerated approval

3 years ago

Novartis petitions Supreme Court in effort to 'vigorously defend' Gilenya patent

3 years ago

Advocacy group accuses Novo Nordisk of violating FDA's 'fair balance' advertising rules

3 years ago

FDA lays the finishing touches on its plan to pull Makena

3 years ago

On orphan drug exclusivity, FDA decides to go its own way after court loss

3 years ago

FDA will consult outside advisors on whether Biogen’s ALS drug can be approved on a biomarker

3 years ago

FDA hopes to simplify and standardize Covid shots without making them interchangeable

3 years ago

Next-gen mpox treatments: FDA calls for diverse, randomized controlled trials

3 years ago

'Blue Brain Boost': FDA blocks Colorado couple from importing and reselling drugs from China

3 years ago

FDA lifts clinical hold on Astellas’ Pompe gene therapy

3 years ago

BeiGene's Brukinsa wins CLL approval after topping Imbruvica in head-to-head trial

3 years ago

FDA squashes accelerated hopes for Eli Lilly’s Alzheimer’s drug as agency asks for more data

3 years ago

New clinical trial system to soon become mandatory in Europe

3 years ago

Rep. Frank Pallone wants FDA and NIH to act on pharma's noncompliance with trial records law

3 years ago

By summer solstice, we'll know the fate of Intercept's NASH drug

3 years ago

Drugmakers seek tweaks to FDA guidance on measuring development in pediatric trials

3 years ago

FDA+ roundup: Lessons learned from two quality ratings pilots; Expanded FDA collab with organ-on-a-chip company

3 years ago

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