FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Gynesonics Sonata Fibroid Device Cleared

[ Price : $8.95]

FDA clears a Gynesonics 510(k) for the (XXXX DELETE XXX) Sonata System 2.2 for treating fibroids.

Expanded EUA for Lilly Covid-19 Prophylaxis

[ Price : $8.95]

FDA expands an Eli Lilly emergency use authorization for bamlanivimab 700 mg and etesevimab 1,400 mg administered together to prov...

Use Surrogate Endpoints More Selectively: Researchers

[ Price : $8.95]

Researchers in the UK and Italy say the use of surrogate endpoints in drug regulation should be tightened.

FDA Extends Review of Calliditas Therapeutics NDA

[ Price : $8.95]

FDA extends by three months the review of a Calliditas Therapeutics NDA seeking accelerated approval for Nefecon (budesonide) for ...

New FDA/EMA Complex Generic/Hybrid Advice Pilot

[ Price : $8.95]

FDA and the European Medicines Agency launch a pilot program to provide parallel scientific advice to ANDA and MMA applicants for ...

FDA Hedges Its Position on Covid Vaccine Booster

[ Price : $8.95]

Amid controversy over whether Covid-19 vaccine booster shots are needed, the FDA Vaccines and Related Biological Products Advisory...

Amylyx Plans NDA for ALS Drug

[ Price : $8.95]

Amylyx Pharmaceuticals plans to submit an NDA in the coming months for AMX0035 (sodium phenylbutyrate and taurursodiol) for treati...

BeiGenes Brukinsa OKd for Marginal Zone Lymphoma

[ Price : $8.95]

FDA grants accelerated approval for BeiGenes Brukinsa (zanubrutinib) for treating adult patients with relapsed or refractory margi...

Fluid Warmers Can Leach Aluminum: FDA

[ Price : $8.95]

FDA reminds healthcare providers that some fluid warmers can leach aluminum into the fluids or blood products being administered t...

FDA Creating Agency-Level Office of Digital Transformation

[ Price : $8.95]

FDA creates an Office of Digital Transformation, reporting to the commissioner, as part of its ongoing information technology and ...