FDA Grants Breakthrough Status to BrainChild Bio’s CAR T Therapy for Pediatric Brain Tumors BrainChild Bio, Inc., a clinical-stage biotechnology company at the forefront of neuro-oncology cell therapy innovation, has achieved a significant regulatory milestone with the announcement that its…
FDA Approves Dupixent as First New Targeted CSU Therapy in Over a Decade Chronic spontaneous urticaria, sometimes referred to as chronic idiopathic urticaria, is a condition characterized by the spontaneous appearance of hives (wheals), swelling (angioedema), or both, for six…
UK MHRA Approves Blenrep Combos for Relapsed/Refractory Multiple Myeloma GSK plc has achieved a critical regulatory milestone with the Medicines and Healthcare products Regulatory Agency (MHRA) granting authorisation for expanded use of Blenrep (belantamab mafodotin-blmf) in the United Kingdom. This…
Aptar Launches Study to Speed FDA Approval of SmartTrack™ Platform for Inhalers AptarGroup, Inc., a global leader in drug delivery and consumer product dispensing systems, has announced a pivotal step in the advancement of its pharmaceutical services with the initiation…
ACIP Backs Pfizer’s RSV Vaccine ABRYSVO for At-Risk Adults Aged 50–59 Pfizer Inc. (NYSE: PFE) has taken a significant step forward in the effort to combat respiratory syncytial virus (RSV) infections among U.S. adults, as the U.S. Centers for Disease…
GSK’s 5-in-1 Meningitis Vaccine PENMENVY Backed by U.S. Advisory Panel In a pivotal step forward for meningococcal disease prevention in the United States, GSK plc announced that the Advisory Committee on Immunization Practices (ACIP), an influential panel advising the US…
eGenesis and OrganOx Secure U.S. FDA IND Clearance for Acute-On-Chronic Liver Failure Treatment eGenesis, a pioneering biotechnology company focused on developing human-compatible engineered organs, and OrganOx Ltd., a leading medical technology company specializing in organ preservation and support systems, today…
ImmunityBio Files Supplemental BLA for NMIBC and Expands ANKTIVA Access for Lymphopenia Treatment ImmunityBio, Inc. (NASDAQ: IBRX), a leading company specializing in immunotherapy, has recently made significant strides in advancing its therapeutic offerings. The company announced the completion of multiple…
Click Therapeutics Secures FDA Approval for First-Ever Prescription Digital Migraine Therapy In a significant milestone for digital health and the millions of people affected by migraine disorders, Click Therapeutics, Inc. has received marketing authorization from the U.S. Food and Drug…
Mirum Receives FDA Approval for Tablet Version of LIVMARLI In a significant advancement for the rare liver disease community, Mirum Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted approval for a new tablet formulation…
New Study Exposes Harmful Effects of IRA’s ‘Pill Penalty’ on Small Molecule Drugs A recently published peer-reviewed study is shedding light on the unintended yet far-reaching consequences of the Inflation Reduction Act (IRA) on the U.S. biopharmaceutical sector—particularly in the…
FDA Approves VYVGART Hytrulo Prefilled Syringe with ENHANZE for Self-Injection in gMG and CIDP In a major development for patients suffering from chronic neuromuscular autoimmune disorders, Halozyme Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted…