Amgen has resisted that withdrawal push, prompting the FDA to double down in April with a formal proposal to pull the drug ...

Viridian Therapeutics has scored an FDA approval for Lumvoa to treat thyroid eye disease (TED), triggering competition with ...

Despite a recent failure as a second-line monotherapy in diffuse B-cell lymphoma (DLBLC), a positive phase 3 combination ...

A Brukinsa regimen has delivered a large progression-free survival (PFS) benefit in what BeOne Medicines called a “new ...

The European Commission has kicked off formal proceedings in an antitrust investigation against Sanofi. The probe surrounds ...

Orca Bio has jumped into the commercial market with FDA approval for Tregzi, a first-of-its-kind engineered cell therapy for blood cancer patients requiring transplants.    | Orca Bio has jumped into ...

In the past two weeks, CARsgen Therapeutics won the world's first regulatory approval for a solid tumor CAR-T Biologics' ...

Four months after Theravance Biopharma shut down its R&D unit, laid off half its staff and signaled it was up for sale, the ...

The transaction is a big splash for Merck KGaA, representing the company’s largest deal since its buyout of Sigma-Aldrich for ...

The FDA has issued a complete response letter to Unicycive over the “same third-party manufacturing deficiencies that were ...

Bayer has scored a key victory in its defense against Roundup lawsuits as the U.S. Supreme Court has tossed a $1.25 million ...

Once the CHMP has delivered marketing authorization recommendations, final sign-off on the decisions must still be conferred ...