FDA+ channel feed – Endpoints News

FDA+ channel feed

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

Panel of neuroscience experts lays out the complications with using Biogen's new Alzheimer's drug

4 years ago

Businesses and schools can mandate the use of Covid-19 vaccines under EUAs, DOJ says

4 years ago

House committee seeks more from FDA on inspection backlog, when to restart work on foreign sites

4 years ago

The clock is ticking for Iterum after FDA hands down CRL for Pfizer castoff antibiotic

4 years ago

Another one bites the dust: Bristol Myers Squibb pulls 'dangling' accelerated approval for Opdivo in liver cancer

4 years ago

FDA unsurprisingly brings down the hammer on Incyte's PD-1 — drawing a line for future accelerated approvals

4 years ago

EMA rejects FDA-approved Parkinson's drug, signs off on Moderna vaccine use in adolescents ahead of FDA

4 years ago

Merck, Eisai notch full approval for Keytruda-TKI inhibitor combo in advanced endometrial cancer

4 years ago

Roche CEO Schwan puts 3-time Alzheimer's loser gantenerumab back in the spotlight as FDA's controversial Aduhelm OK inspires blockbuster forecasts

4 years ago

In 60 days, most insurers will be required to cover HIV prevention drugs and related services with no cost-sharing

4 years ago

How cozy is too cozy? FDA and Biogen offer up a test case

4 years ago

Sanofi's sleeping sickness drug wins FDA OK and a lucrative priority review voucher too

4 years ago

New study shows smaller biopharma companies struggle more than larger ones with clinical trial transparency

4 years ago

Albireo caps a big week with back-to-back approvals in the US/EU for the first drug to treat a severe liver disease

4 years ago

FDA rejects professor’s petition seeking to pull ‘dangerous’ Otsuka kidney disease drug

4 years ago

Industry groups warn of drug shortages linked to widespread carcinogen testing as FDA doubles down on its approach

4 years ago

Ardelyx craters after FDA stuns analysts and rejects their kidney disease pitch

4 years ago

First page Previous page 103 104 105106107 108 109 Next page Last page