regulatory approval

News

Amgen, AZ's Tezspire challenges Dupixent in nasal polyps

Amgen and AstraZeneca's fast-growing asthma drug Tezspire is now poised to take on rival Dupixent in chronic rhinosinusitis with nasal polyps.

News

FDA clears Roche, Lilly Alzheimer's blood test

A blood test developed by Roche and Eli Lilly that could help diagnose patients with Alzheimer's more quickly has been approved by the FDA.

News

Kelun gets world-first approval for TROP2 ADC

Kelun-Biotech has picked up another world-first approval for its TROP2-targeting ADC sac-TMT in non-small cell lung cancer.

News

Regeneron's Libtayo stakes out new territory in skin cancer

Regeneron's Libtayo has become the first checkpoint inhibitor to be cleared by the FDA as an adjuvant treatment for cutaneous squamous cell carcinoma.

News

Boehringer bags FDA okay for new pulmonary fibrosis drug

Boehringer's successor to blockbuster IPF therapy Ofev has been approved by the FDA as Jascayd, but will the new drug be a commercial success?

News

Roche gets EU nod for kidney disease algorithm

Roche and Klinrisk have picked up a CE-mark for an AI tool that can be used to predict renal function decline in patients with chronic kidney disease.

Amgen, AZ's Tezspire challenges Dupixent in nasal polyps

FDA clears Roche, Lilly Alzheimer's blood test

Kelun gets world-first approval for TROP2 ADC

Regeneron's Libtayo stakes out new territory in skin cancer

Boehringer bags FDA okay for new pulmonary fibrosis drug

Roche gets EU nod for kidney disease algorithm

Bayer gets swift review for Kerendia in type 1 diabetes

Discover a new era of healthcare panel engagement: Grounded ...

regulatory approval

Editor's Picks