With the FDA approval for Tregzi, Orca Bio has become one of very few U.S.-based commercial drugmaker that remains privately held. (Getty Images) Orca Bio has jumped into the commercial market with an ...
Biopharma giants Eli Lilly and Regeneron and rapidly growing contract manufacturers Fujifilm and Cellares are among the seven ...
Despite a recent failure as a second-line monotherapy in diffuse B-cell lymphoma (DLBLC), a positive phase 3 combination ...
The FDA has issued a complete response letter to Unicycive over the “same third-party manufacturing deficiencies that were ...
AstraZeneca will pay $34 million to resolve a lawsuit that alleged the company used illegal kickbacks to induce providers to ...
As Amgen’s rare disease medicine Tavneos comes under intensifying pressure from the FDA, the company faces a new hurdle with ...
A Brukinsa regimen has delivered a large progression-free survival (PFS) benefit in what BeOne Medicines called a “new ...
Klick Health has struck its third takeover in 18 months, snapping up Oxford PharmaGenesis to expand its global reach and ...
Viridian Therapeutics has scored an FDA approval for Lumvoa to treat thyroid eye disease (TED), triggering competition with ...
Four months after Theravance Biopharma shut down its R&D unit, laid off half its staff and signaled it was up for sale, the ...
Once the CHMP has delivered marketing authorization recommendations, final sign-off on the decisions must still be conferred ...
The European Commission has kicked off formal proceedings in an antitrust investigation against Sanofi. The probe surrounds ...