Pfizer Inc revealed that the US Food and Drug Administration (FDA) has authorized BRAFTOVI (encorafenib) alongside cetuximab (sold as ERBITUX) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for treating patients with metastatic...
Lipocine Inc., a biopharmaceutical company utilizing its own technology platform to enhance therapeutics via efficient oral delivery, reported that the US Food and Drug Administration (FDA) has awarded Fast Track Designation to LPCN 1148 for...
Merck announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), the company's experimental long-acting monoclonal antibody aimed at safeguarding infants from...
Smith+Nephew, the worldwide medical technology firm, announces it has obtained 510(k) authorization from the United States Food & Drug Administration for a stemless anatomical total shoulder for the AETOS Shoulder System (AETOS Stemless). AETOS...
Gerresheimer, a creative systems and solutions provider and a worldwide partner for the pharmaceutical, biotech, and cosmetics sectors, has announced that the US Food and Drug Administration (FDA) has granted SQ Innovation Tentative Approval for...
Ascendis Pharma A/S, a worldwide pharmaceutical firm utilizing its cutting-edge TransCon technology platform to develop a prominent and fully integrated biopharma business dedicated to significantly improving patients' lives, reported that the US...
The MHRA in the UK has given the approval to sparsentan (Filspari) for the treatment of IgAN. Berger's disease, or IgA neuropathy, is a kidney condition caused by the accumulation of immunoglobulin A (IgA) antibodies in the kidneys. Sparsentan...
Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company fully owned and autonomously operating as a subsidiary of Bayer AG, announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug...
Bayer revealed that it received approval from the U.S. Food and Drug Administration (FDA) for its MEDRAD® Centargo CT Injection System, a groundbreaking multi-patient injector that enhances workflow efficiency through design elements that align...
The US FDA awards Rare Paediatric Disease Designation to encourage the development of drugs for serious conditions impacting fewer than 200,000 children in the US. Since these illnesses present distinct hurdles for drug development...
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