GSK Receives US FDA Approval for Expanded Use of RSV Vaccine Arexvy
GSK has received approval from the US Food and Drug Administration (FDA) for the expanded use of its respiratory syncytial […]
Pharma
Zydus Lifesciences’ Desidustat Receives Approval from China’s NMPA
Zydus Lifesciences has received approval from China’s National Medical Products Administration (NMPA) for Desidustat tablets, indicated for the treatment of […]
Merck Signs MoU with Cyto-Facto to Advance Cell and Gene Therapy Manufacturing in APAC
Merck has signed a non-binding Memorandum of Understanding (MoU) with Cyto-Facto Inc., a Contract Development and Manufacturing Organization (CDMO) focused […]
US FDA Approves Leucovorin for Rare Genetic Disorder Causing Autism-Like Symptoms
The US Food and Drug Administration (FDA) has approved leucovorin for the treatment of cerebral folate deficiency (CFD), a rare […]
BioNTech Founding Couple to Step Down to Launch New Biotech Venture
BioNTech founders Ugur Sahin and Oezlem Tuereci have announced plans to step down from their roles at the German biotechnology […]
Aurobindo Pharma Completes US FDA Inspection at Eugia Unit-I with Four Observations
Aurobindo Pharma Limited announced the completion of a United States Food and Drug Administration (US FDA) inspection at Unit-I of […]
Glenmark’s US Arm to Launch Sodium Phosphate Injection; Distribution to Begin in April
Glenmark Pharmaceuticals Ltd. has announced that its wholly owned subsidiary, Glenmark Pharmaceuticals Inc., USA, will launch Sodium Phosphate Injection in […]
US FDA Approves First-Line Use of Boehringer Ingelheim’s Lung Cancer Drug
The US Food and Drug Administration (FDA) has approved the first-line use of Boehringer Ingelheim’s lung cancer therapy zongertinib for […]
Dr Reddy’s Gears Up for March Launch of Generic Semaglutide ‘Obeda’ in India
Dr Reddy’s Laboratories is preparing to introduce its generic semaglutide injection in India, likely to be marketed under the brand […]
US FDA Approves Eton Pharma’s Liquid Therapy for Rare Water-Balance Disorder
The US Food and Drug Administration (FDA) has approved Eton Pharmaceuticals’ liquid therapy Desmoda, an oral solution formulation of desmopressin […]
Moderna’s Flu–COVID Combination Vaccine Advances After Successful Mid-Stage Trial
Moderna has announced positive mid-stage clinical trial results for its investigational combination vaccine targeting seasonal influenza and COVID-19, advancing its […]
BahiaFarma, Biocon Biologics and Bionovis Sign MoU for Oncology Biologics Development
BahiaFarma, Biocon Biologics and Bionovis have entered into a memorandum of understanding (MoU) to collaborate in the pharmaceutical sector with […]
FDA Drops Two-Study Requirement to Fast-Track New Drug Approvals
The US Food and Drug Administration (FDA) has decided to eliminate its requirement that new drug approvals be supported by […]
