Pharmaceuticals, Biotechnology and Life Sciences
FDA said that GSK’s sotrovimab is not authorized in any U.S. state or territory at this time, as CDC’s data showed the authorized dose of sotrovimab is unlikely to be effective against the BA.2 sub-variant.
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Novartis-s Vijoice (alpelisib) for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.
The European Commission (EC) has approved Bristol Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression ≥ 1%.
The U.S. Food and Drug Administration (FDA) has granted commercial licensure approval for Novartis’s Durham, N.C. site, a multi-product gene therapy manufacturing facility.
Moderna, Inc. (NASDAQ:MRNA), has launched the Moderna Charitable Foundation to promote public health, access to quality healthcare and educational opportunities, particularly in underserved populations.
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Sanofi’s…
Novartis has announced the introduction of a new organizational structure and operating model designed to support the company’s innovation, growth, and productivity ambitions as a focused medicines company in the coming decade.
Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its anti-CD112R monoclonal antibody (TAB009/JS009) for the treatment of advanced solid tumors.
BMS has published data showing treatment with mavacamten showed sustained improvement in left ventricular outflow tract (LVOT) gradients, New York Heart Association (NYHA) Class and N-terminal pro brain natriuretic peptide (NT-proBNP) levels.
Bristol Myers Squibb (NYSE: BMY) has announced results from the Phase 3 VALOR-HCM study, which showed the addition of mavacamten, an investigational, first-in-class cardiac myosin inhibitor, significantly reduced the need for septal reduction therapy (SRT) in patients with severely symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM) who had been appropriate for SRT per the 2011 American College of Cardiology/American Heart Association (ACC/AHA) Guidelines at baseline.