The World Health Organization (WHO) has prequalified the initial diagnostic test for glucose-6-phosphate dehydrogenase (G6PD) deficiency, which can assist in the safe administration of WHO-approved treatments to prevent recurrence of Plasmodium...
Roche announced that its complete slide imaging system, Roche Digital Pathology Dx, has obtained an additional 510(k) clearance from the U.S. Food and Drug Administration (FDA). This approval alters the one Roche obtained on June 14, 2024, for Ro...
Dizal, a biopharmaceutical firm dedicated to creating innovative therapies for cancer and immunological disorders, revealed that the U.S. Food and Drug Administration (FDA) has accepted and assigned priority review to the company's New Drug...
JCR Pharmaceuticals Co., Ltd., a worldwide specialty pharmaceuticals firm, and Modalis Therapeutics Corporation, a leader in epigenetic medicine, have revealed that they have confirmed the preliminary proof of concept in a joint research programme...
Acurx Pharmaceuticals, Inc., a late-stage biopharmaceutical firm dedicated to creating a novel class of small molecule antibiotics for challenging bacterial infections, announced that it has obtained positive regulatory guidance from the EMA in...
Astellas Pharma Inc. announced that China’s National Medical Products Administration (NMPA) has given the approval to Vyloy (zolbetuximab), in conjunction with fluoropyrimidine- and platinum-based chemotherapy, for the initial treatment of...
NMD Pharma A/S, a biotech firm in the clinical stage focused on creating innovative and enhanced therapies for individuals with neuromuscular disorders, revealed that the U.S. Food and Drug Administration (FDA) has awarded orphan drug designation...
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...
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