Vertex has secured a label expansion through the FDA's Commis | Vertex Pharmaceuticals has gained a label expansion from the ...

Amgen has issued a voluntary recall for nearly 1 million bottles of the heart medication Corlanor (ivabradine) due to possible contamination. The nationwide recall was issued by the company on June 4 ...

Biopharma giants Eli Lilly and Regeneron and rapidly growing contract manufacturers Fujifilm and Cellares, are among the ...

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

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

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

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

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 ...

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

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

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