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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Pharmaceutical company Lupin announced that it has received authorization from the US health authority to commercialize generic HIV drug in the US market. The Mumbai-based drug manufacturer announced in a statement that it has obtained provisional...
Roche reported that the US Food and Drug Administration (FDA) has provided 510(k) clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat panels for multiplex testing of sexually transmitted infections...
Poxel SA, a biopharmaceutical firm at the clinical stage focusing on developing groundbreaking therapies for chronic serious diseases characterized by metabolic pathophysiology, such as metabolic dysfunction-associated steatohepatitis (MASH)...
Opella, the Consumer Healthcare division of Sanofi, announced that the US Food and Drug Administration (FDA) has removed a clinical hold on its proposed actual use trial (AUT) aimed at facilitating the transition of Cialis (tadalafil) from...
The Competition Commission approved the merger of nine entities with the pharmaceutical company Sequent Scientific Ltd (SSL). "The suggested merger entails a sequence of linked actions executed for the integration of SRL, Viyash, Symed, Appcure...
Binita Shah, Co-founder of BDR Pharmaceuticals, engaged in a conversation with India Pharma Outlook, to explain how CSR is becoming integral to HR in the Indian pharma industry, focusing on community-driven initiatives like healthcare awareness,
GSK plc announced that the European Commission has authorized Jemperli (dostarlimab) in conjunction with chemotherapy (carboplatin and paclitaxel) as a first-line therapy for adult patients with primary advanced or recurrent endometrial cancer...
Strides Pharma Science Limited has announced that its wholly owned subsidiary, Strides Pharma Global Pte Limited, Singapore, has obtained approval from the United States Food & Drug Administration (USFDA) for Acetaminophen and Ibuprofen Tablets...
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