While argenx has been able to demonstrate the merit of its FcRn drug Vyvgart in multiple autoimmune indications, not every ...

Clearing clinical and regulatory hurdles in the development of a fast-acting nasal spray for a heart condition has given ...

After a three-decade drought of new antibiotics to treat gonorrhea, the FDA has signed off on two first-in-class oral ...

About a year and a half after telegraphing plans to shift its headquarters from New Jersey to Philadelphia, CDMO Adare Pharma ...

GSK’s depemokimab, a long-acting biologic that’s key in the British pharma’s growth plan, has won an endorsement from ...

The inaugural approval under the program has gone to USAntibiotics and its domestically manufactured extended-release ...

Gamida Cell has scored an expansion for Omisirge, with the FDA endorsing the stem cell-based therapy to treat severe aplastic ...

Amid a swell of regulatory successes in the myasthenia gravis arena this decade, Amgen is wading into the fray with a new ...

Thursday, the FDA addressed the shortfall with a label expansion for GSK’s Blujepa, which brings an oral option and a new ...

Eli Lilly will not seek a broad FDA approval for a combination of the company’s oral SERD med Inluriyo and CDK4/6 inhibitor ...

After beefing up the target of its global cost-savings drive once again, Pfizer is continuing to see its plan through with ...

Pfizer is paying top dollar for a GLP-1 candidate from Fosun Pharma. Zealand Pharma penned a platform deal with brand new ...