Page 55 - Approval Program News Today

CEOs of more than 400 pharmaceutical companies, including Pfizer, issued a fiery condemnation of Judge Matthew Kacsmaryk's mifepristone abortion ruling.

Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for...

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patientsRAHWAY, N.J.--(BUSINESS WIRE)--$MRK #MRK--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA,...

– First treatment option combining an antibody-drug conjugate plus a PD-1 inhibitor in this patient population –BOTHELL, Wash. & TOKYO--(BUSINESS WIRE)--Seagen Inc. (Nasdaq: SGEN) and Astellas Pharma Inc. (TSE:4503) today announced the U.S. Food and Drug Administration (FDA) has granted PADCEV® (enfortumab vedotin-e...

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients ... | April 3, 2023

– First treatment option combining an antibody-drug conjugate plus a PD-1 inhibitor in this patient population – ... | April 3, 2023

/PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Seagen Inc. (Nasdaq: SGEN) today announced the U.S. Food and...

Life News

As policymakers search for potential cuts to the national budget, they risk jeopardizing the country’s most cost-effective use of healthcare dollars: biomedical innovation regarding vaccines, prescription drugs, and emerging therapies, including antibodies. As the nation rapidly ages, protecting this pipeline of medicine will not only improve health outcomes but will do so at a lower cost by reducing more expensive hospital and primary care.

Mixed votes from an FDA advisory panel may help Biogen secure accelerated approval of ALS drug tofersen, licensed from Ionis Pharmaceuticals.