Roche Receives FDA Clearance for CLIA-Waived STI Point-of-Care Tests Roche has announced a major milestone in the realm of sexual health diagnostics. The U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance and Clinical Laboratory Improvement Amendments…
Eli Lilly and Company has announced that the U.S. FDA has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn’s disease in adults. This approval marks a significant milestone for the company, as Omvoh is now approved…
Incyte and Syndax Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approval of Niktimvo™ (axatilimab-csfr) in 9 mg and 22 mg vial sizes. The companies expect the product to be available for order in the United States by early…
Datopotamab Deruxtecan Granted Priority Review by FDA for Advanced EGFR-Mutated NSCLC AstraZeneca and Daiichi Sankyo recently announced that the U.S. Food and Drug Administration (FDA) has accepted their Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd). This development marks a…
Introduction to Heart Failure and the Need for New Treatments Bayer has announced that it has submitted marketing authorization applications to both the U.S. Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE), seeking approval for finerenone…
Biologics License Grifols Advances Fibrinogen Solution with U.S. FDA Submission Biologics License Grifols a global healthcare company and leading manufacturer of plasma-derived medicines, has announced the submission of a Biologics License Application (BLA) for its innovative fibrinogen treatment to the…
GSK Receives FDA Breakthrough Therapy Designation for GSK5764227 in Osteosarcoma Treatment GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for GSK5764227 (GSK’227), its targeted antibody-drug conjugate (ADC) designed to treat…
The oncology pharmaceuticals market, valued at $196.4 billion in 2023, is expected to grow at a robust compound annual growth rate (CAGR) of 12.7%, reaching $401.4 billion by 2029. This remarkable growth is driven by several factors, including increasing cancer…
Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) Injection for subcutaneous use. This innovative combination product includes nivolumab, an immunotherapy agent, co-formulated with recombinant human hyaluronidase…
The Egyptian Drug Authority has granted regulatory approval for insulin glargine injection manufactured by EVA Pharma in collaboration with Eli Lilly and Company. This approval marks a significant milestone in the partnership that was launched in 2022, aiming to provide…
Merck known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for clesrovimab (MK-1654), an investigational long-acting monoclonal antibody designed to protect infants from…
Gilead Sciences, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed following platinum-based chemotherapy. This designation…