PFIZER Clostridium difficile Vaccine did not meet primary endpoints: PHASE 3 CLOVER Trial MD Bureau6 March 2022 1:29 PM ISTNew York: Pfizer Inc. announced results from the CLOVER trial (CLOstridium difficile Vaccine Efficacy TRial), a pivotal Phase 3 study evaluating its...
FDA declines pediatric EUA to Covaxin Medical Dialogues Bureau5 March 2022 2:56 PM ISTNew Delhi: Ocugen Inc (OCGN.O) said on Friday U.S. regulators have declined to issue an emergency use authorization (EUA) for Covaxin, the COVID-19...
USFDA issues 3 minor observations to Granules India arm in pre-approval inspection MD Bureau4 March 2022 12:38 PM ISTCommenting on the audit, GPI Executive Director Priyanka Chigurupati said, "We are glad to have completed yet another audit with minor observations...
Lupin's Efinaconazole Topical Solution gets USFDA nod MD Bureau4 March 2022 12:09 PM ISTLupin today announced that it has received approval from the USFDA for its ANDA, Efinaconazole Topical Solution, 10%to market a generic equivalent of...
Lupin gets USFDA nod for Sevelamer Hydrochloride Tablets MD Bureau3 March 2022 2:05 PM ISTSevelamer Hydrochloride Tablets, 800 mg is a generic equivalent of Renagel® Tablets, 800 mg of Genzyme Corporation.
USFDA accepts Bristol Myers Squibb's Application for Opdivo MD Bureau2 March 2022 12:10 PM ISTThe FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 13, 2022.
USFDA accelerates approval of CTI BioPharma's pacritinib MD Bureau1 March 2022 12:44 PM ISTVONJO is a novel oral kinase inhibitor. VONJO is the first approved therapy that specifically addresses the needs of patients with cytopenic...
Unichem Labs gets USFDA nod for Divalproex Sodium ER Tablets Ruchika Sharma28 Feb 2022 4:48 PM ISTMumbai: Drugmaker, Unichem Laboratories Limited, today announced that the company has received approval from the United States Food and Drug...
Sun Pharma, Aurobindo recall products in US over defaulting norms MD Bureau28 Feb 2022 1:18 PM ISTNew Delhi: Leading homegrown drug makers Aurobindo Pharma and Sun Pharmaceutical Industries are recalling different products in the US market due to...
Boehringer Ingelheim gets USFDA Breakthrough Therapy Designation for BI 1015550 MD Bureau28 Feb 2022 11:00 AM ISTGermany: Boehringer Ingelheim has announced that the U.S. Food and Drug Administration (USFDA) has granted Breakthrough Therapy Designation to its...
Pfizer supplemental application for ABRILADA interchangeability accepted by USFDA for review MD Bureau27 Feb 2022 10:30 AM ISTNew Delhi: Pfizer Inc. has announced that the U.S. Food and Drug Administration (USFDA) has accepted for review the Prior Approval Supplement (PAS) to...
Eli Lilly, Boehringer Ingelheim gets USFDA nod for Jardiance to treat heart failure regardless of ejection fraction MD Bureau26 Feb 2022 11:00 AM ISTIndianapolis: Eli Lilly and Company and Boehringer Ingelheim have recently announced that the U.S. Food and Drug Administration (USFDA) has...
