Capricor Therapeutics, a biotech firm focused on developing innovative cell and exosome-based therapies for rare diseases, has announced the completion of the submission of its Biologics License Application (BLA) to the US Food and Drug...
The Centre intends to extend the deadline for complying with good manufacturing practice (GMP), aligned with World Health Organization (WHO) standards, for small pharmaceutical firms earning ?250 crore or below by one year to 31 December 2025...
The Indian drug regulatory authority, Central Drugs Standard Control Organization (CDSCO), has authorized Miqnaf (nafithromycin) as a new treatment for Community-Acquired Bacterial Pneumonia (CABP) in adults. Miqnaf is a rapid, three-day treatment...
Biocon Pharma Ltd has secured approval from China's National Medical Products Administration (NMPA) for its Tacrolimus capsules available in 0.5mg, 1mg, and 5mg dosages. Tacrolimus, an immunosuppressive medication, is utilized to inhibit organ...
Verastem Oncology, a biopharmaceutical company committed to advancing new medicines for patients with cancer, announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) under the accelerated...
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...
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