C2 PHARMA has disclosed the approval of a Certificate of Suitability (CEP) for Oxybuprocaine Hydrochloride from the European Directorate for the Quality of Medicines and Health Care (EDQM). Oxybuprocaine Hydrochloride is presently accessible to...
Datopotamab deruxtecan (Dato-DXd) has received a recommendation for approval in the European Union (EU) to treat adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast...
Bavarian Nordic A/S, a worldwide vaccine firm dedicated to enhancing health and saving lives via innovative vaccines, revealed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a...
Houston-based March Biosciences, an emerging clinical stage biotechnology company committed to combating challenging cancers and other diseases, announced that the US Food and Drug Administration (FDA) granted orphan drug designation to MB-105...
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...
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