FDA+ channel feed – Endpoints News

FDA+ channel feed

Priority review voucher updates: Who's won PRVs, who's bought them, and how much they're selling for

4 years ago

Bluebird forced to halt trials after a cancer-like case, pulls gene therapies from Europe following pricing backlash — shares slammed

4 years ago

Letter from FDA outlining deficiencies for lead drug causes Axsome stock to crater. Is a CRL on the way?

4 years ago

Sanofi wins approval for Lumizyme successor, although uptake remains a mystery

4 years ago

FDA shoots down Spectrum's neutropenia drug, citing manufacturing issues

4 years ago

Court decision pushes FDA to make historical shift and regulate borderline drug/device products as devices

4 years ago

FDA orders clinical hold on Aprea's p53 reactivator as struggling biotech pledges to address safety concerns

4 years ago

Novavax shares dive on yet another stumble in the hunt for an EUA, with FDA delay as US pauses funding

4 years ago

ICER offers final verdict against Biogen's aducanumab: No proof it works, clear prospect of harm, wildly overpriced

4 years ago

HHS extends Aduhelm investigation into the accelerated approval pathway, wading into a brewing controversy

4 years ago

Biogen, Eisai are pushing for another accelerated Alzheimer's OK — this time for BAN2401

4 years ago

FDA slaps back small-cap's bid to repurpose 50-year-old chemotherapy

4 years ago

Ardelyx chops a third of its staff after stock-crushing failure in chronic kidney disease

4 years ago

Opinion: Pricing info with new drug approvals: Time for transparency

4 years ago

FDA lifts year-plus hold on Novartis' Zolgensma, setting the stage for new PhIII

4 years ago

Rare disease drugmakers to Congress: Don't gut the accelerated approval pathway

4 years ago

After struggling with its sole drug for years, Marinus rides positive data to a commercialization deal in Europe

4 years ago

Watch out GlaxoSmithKline: AstraZeneca's once-failed lupus drug is now approved

4 years ago

When is a drug intended for a specific use? Not just when it's promoted as such, FDA says in long-awaited final rule

4 years ago

FDA sends 2nd noncompliance notice for company failing to post trial results as crackdown ramps up

4 years ago

Cavazzoni in the hot seat: House committee grills CDER director on neuro drugs

4 years ago

FDA's oncology head Rick Pazdur defends the accelerated approval pathway, claiming it is 'under attack'

4 years ago

Insulin biosimilar wins first-ever interchangeable designation from FDA

4 years ago

In halting confirmatory trial for Oncopeptides' accelerated approval, FDA notes increased risk of death

4 years ago

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