News and Updates by the Food and Drugs Administration (FDA)
BrioHealth Solutions revealed today that it has begun enrolling its initial cohort of patients in the United States for the INNOVATE clinical study of its BrioVAD system. Hailing from Burlington, Massachusetts, BrioHealth has been developing its BrioVAD technology since 2008. […]
BrioHealth Initiates Patient Enrollment for LVAD Research Read More »
BD (NYSE: BDX) recently revealed the appointment of Rima Alameddine as the global president of its Peripheral Intervention division, effective from May 13. Alameddine will lead the division’s global strategies, operations, quality, and commercial efforts, reporting directly to Rick Byrd,
BD Names Rima Alameddine as Global President of Peripheral Intervention Read More »
Bayer is further enhancing its extensive radiology portfolio, making strides with development initiatives and innovations in the field of artificial intelligence (AI). At the 2024 Radiological Society of North America (RSNA) Annual Meeting, scheduled from December 1-5 in Chicago, USA,
Bayer Presents Radiology Innovations at 2024 RSNA Event Read More »
Neo Medical SA, a pioneering Swiss firm in spinal surgery technology, has proudly announced that its full suite of products has gained approval under the European Union’s updated Medical Device Regulation (MDR) EU 2017/745. This accomplishment underscores the company’s adherence
Renalys Pharma, Inc., a biopharmaceutical company advancing in late-stage clinical trials, has announced that its drug sparsentan, acquired from Travere Therapeutics, Inc. (Travere), currently undergoing phase III studies in Japan, has been granted Orphan Drug Designation by Japan’s Ministry of
Everest Medicines, a prominent biopharmaceutical firm dedicated to pioneering drug discovery, clinical progress, production, and bringing novel treatments to market, announced the Hong Kong Special Administrative Region’s Department of Health has accepted their New Drug Application (NDA) for Velsipity (etrasimod).
Mallinckrodt plc, renowned for its specialty pharmaceutical solutions, has officially concluded the sale of its Therakos unit to CVC Capital Partners Fund IX in a deal valued at $925 million, subject to standard adjustments. Siggi Olafsson, serving as president and
Mallinckrodt Finalizes Sale of Therakos Division to CVC Capital Partners Fund IX Read More »
The Suvarna Karnataka Chemists and Distributors Association (SKCDA) has called upon the state’s administration to retract the suspension of the Karnataka drugs controller, Dr. Umesh S. This suspension was declared by Chief Minister Siddaramaiah on November 30, who also insisted
SKCDA Requests Karnataka Government to Revoke Suspension of Drugs Controller Read More »
Dr. H.G. Koshia, Commissioner of Gujarat FDCA, has announced that Indian Pharma MSMEs are adopting the Revised Schedule M guidelines with greater enthusiasm. They are preparing to develop a comprehensive Pharmaceutical Quality System (PQS), integrate Quality Risk Management (QRM), conduct
The All India Public and Private Sector Pharmacists Association (AIPPSPA), a national collective of pharmacist organizations, is gearing up to hold a meeting with representatives from across the nation in Kerala on December 7 and 8. This gathering is organized