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…
Neurocrine Biosciences,has announced that the U.S. Food and Drug Administration (FDA) has approved CRENESSITY™ (crinecerfont) capsules and oral solution for use as an adjunctive treatment to glucocorticoid replacement in adults and pediatric patients aged four years and older with classic…
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tolebrutinib for the treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). This decision is based on promising data from the HERCULES Phase 3 study, which…
Senegal and Rwanda have joined an elite group of African nations by achieving Maturity Level 3 (ML3) status in the World Health Organization’s (WHO) global classification of national regulatory authorities. This milestone reflects their dedication to providing safe, effective, and…
Applied Therapeutics, the biopharmaceutical company focused on developing treatments for rare diseases, recently received a warning letter from the U.S. Food and Drug Administration (FDA) following concerns raised about the conduct of its clinical trial for govorestat. The letter, issued…