Novo Nordisk fast-tracks higher-dose obesity drug to FDA

The drug, intended for chronic weight management alongside diet and exercise, is now under the FDA’s new CNPV expedited review pathway

Lords Mark bets big on AI-driven dialysis tech, buys 85% stake in Renalyx Health

Renalyx will continue operating as an independent unit within the group

Zydus receives FDA’s tentative approval for Empagliflozin and Linagliptin tablets

Zydus receives FDA’s final approval for Verapamil Hydrochloride ER tablets

BioNxt secures Eurasian patent for breakthrough sublingual MS therapy

The Eurasian Patent Organization (EAPO) has granted Patent, protecting the company’s sublingual delivery technology for anticancer drugs used to treat autoimmune and neurodegenerative diseases

Piramal Pharma Solutions’ UK facility bags updated MHRA GMP certification

Grangemouth serves as PPS’s dedicated antibody-drug conjugate development and manufacturing hub

HRV Pharma and MetroChem forge CDMO alliance to fast-track NCE-1 API development

Both companies will jointly execute development and scale-up of multiple strategic APIs, including late-stage NCE-1 opportunities

Zydus receives final approval from USFDA for Leuprolide Acetate injection

Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer

Zydus receives FDA final approval for Diroximel fumarate delayed-release capsules, 231 mg

Diroximel fumarate delayed-release capsules, 231 mg, are indicated for the treatment of relapsing forms of multiple sclerosis

Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'

The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases