Granules India Limited, an integrated Indian pharma firm, declared that its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI), has obtained final approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New...
NATCO Pharma announced that it has obtained approval for its ANDA concerning Everolimus tablets for oral suspension (TFOS), a generic equivalent of AFINITOR DISPERZ from Novartis Pharmaceutical Corporation. Breckenridge Pharmaceutical, Inc, the...
Beckman Coulter Diagnostics, a worldwide frontrunner in clinical diagnostics, declared that the US Food and Drug Administration (FDA) has awarded Breakthrough Device Designation to Beckman Coulter's Access p-Tau217/ß-Amyloid 1-42 plasma ratio...
Global pharmaceutical giant Lupin Limited has revealed that it has gained approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Ipratropium Bromide Nasal Solution (Nasal Spray)...
The U.S. Food and Drug Administration (FDA) has approved 510(k) clearance for Fresenius Kabi’s Adaptive Nomogram, a different algorithm to be included in the Aurora Xi Plasmapheresis System aimed at enhancing plasma collection efficiency...
Aurobindo Pharma revealed that the United States Food and Drug Administration (USFDA) has provided an establishment inspection report (EIR) to its subsidiary's active pharmaceutical ingredient (API) facility in Telangana, categorizing it as...
Clinigen, a worldwide expert in pharmaceutical services, has formed a strategic alliance with Tepsivo, a provider of digital Pharmacovigilance (PV) services. In the framework of the partnership, Clinigen has obtained a minority share in Tepsivo...
The government is expected to grant an extension until December this year for the drug manufacturers to comply with the updated Schedule M. They stated that the drug regulations will be revised to allow for an extension of time. Once the last...
Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Supplemental Biologics License Application (sBLA) for lecanemab-irmb, administered intravenously (IV) once every four weeks as...
In a joint workshop between CDSCO and the Confederation of Indian Industry, Aseem Sahu, Deputy Drugs Controller, Medical Device Division, CDSCO, shares his view on the regulatory requirements for medical devices, components, and import...
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