FDA clears Travere’s FILSPARI for expanded use in rare kidney disease

FDA grants priority review to Daiichi Sankyo & Merck’s lung cancer drug application

The investigational therapy, ifinatamab deruxtecan, is a potential first-in-class B7-H3 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with Merck

FDA presses 2,200+ companies to fix missing clinical trial results

Move amid evidence of widespread reporting gaps

FDA fast-tracks Daiichi Sankyo & Merck lung cancer drug review

The FDA is also reviewing the application under its Real-Time Oncology Review (RTOR) program and Project Orbis

Haemonetics gains FDA nod to expand VASCADE MVP XL for larger sheaths in heart procedures

The approval now covers procedures using 10-14F inner diameter and up to 17F outer diameter procedural sheaths

Orbicular, Apotex win tentative USFDA nod for generic Ozempic

Hyderabad-based peptide specialist strengthens complex generics credentials as Apotex prepares for U.S. commercialization of semaglutide injection

Zeto gains FDA nod for new outpatient EEG system promising faster brain health testing

The FDA clearance of Zeto New Wave marks the company’s third cleared device, alongside Zeto WR19 and Zeto ONE

Lupin scores major US breakthrough with FDA nod for key diabetes drug

The Abbreviated New Drug Application with FDA covers multiple strengths of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets

VDYNE gets FDA nod to launch pivotal US trial for tricuspid valve device

The approval clears the way for a US study at leading clinical centers to evaluate the safety and effectiveness of VDYNE’s system in patients

Glenmark gets USFDA approval for generic Endometrin vaginal inserts

Final approval for progesterone vaginal inserts expands Glenmark’s women’s healthcare portfolio in the US, targeting a market of over $59 million