Lupin Limited Secures U.S. FDA Nod for Glycerol Phenylbutyrate Oral Liquid in Urea Cycle Disorders
Lupin has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application...
New Meta-Analysis Ranks CAPLYTA®️ Lumateperone First in Efficacy and Metabolic Safety for Adjunctive MDD Treatment
Intra-Cellular Therapies, Inc. announced the presentation of a new network meta-analysis (NMA) demonstrating that CAPLYTA® (lumateperone) showed the greatest improvement across four key efficacy outcomes among...
GloGen Clinical Research Reports USFDA EIR with ‘Closed’ Status Following February Inspection
GloGen Clinical Research Pvt. Ltd. has received the Establishment Inspection Report (EIR) from USFDA, with the determination of “Closed”, auditorium conducted on 09th -13th...
Intervein Clears USFDA Inspection, Strengthens Global Standards in IVRT & IVPT
Intervein Research Labs Pvt. Ltd. has successfully completed a recent inspection by the U.S. Food and Drug Administration, marking a key milestone in its regulatory...
Glenmark Pharmaceuticals Wins U.S. FDA Nod for Generic Progesterone Fertility Therapy
Glenmark Pharmaceuticals has received final approval from the U.S. Food and Drug Administration for its Progesterone Vaginal Inserts, 100 mg, marking a meaningful step forward in expanding...
KM Biologics and Serum Institute of India Enter Strategic Partnership to Enhance Global Access to Japanese Encephalitis Vaccines
Meiji Seika Pharma Co., Ltd. announced that its subsidiary, KM Biologics Co., Ltd., has achieved the first technical milestone in its strategic collaboration with...