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…
FDA Approves Opdivo and Yervoy Combo as First-Line Treatment for Advanced Liver Cancer In a significant advancement for liver cancer treatment, Bristol Myers Squibb (NYSE: BMY) has announced that the U.S. Food and Drug Administration (FDA) has granted full approval…
Arcturus Therapeutics Secures FDA Fast Track Designation for ARCT-2304, a Next-Generation sa-mRNA Vaccine Targeting Pandemic Influenza A (H5N1) In a significant milestone for mRNA vaccine innovation, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT), a late-stage clinical biotech company pioneering messenger RNA-based…
FDA Grants Full Approval to Bayer’s VITRAKVI® (Larotrectinib), a Landmark TRK Inhibitor for Patients with NTRK Fusion-Positive Solid Tumors In a milestone for precision oncology, Bayer announced today that the U.S. Food and Drug Administration (FDA) has granted full regulatory…
New Cancer Cell Study Backs CEL-SCI’s Early Approval Bid for Multikine in Head & Neck Cancer CEL-SCI Corporation (NYSE American: CVM), a clinical-stage immunotherapy company developing innovative treatments for cancer and infectious diseases, today announced findings that reinforce the scientific…
Agitated Solutions Gets FDA IND Nod for Phase 3 Contrast Agent Trial Agitated Solutions, Incorporated (ASI), a medical technology company focused on cardiovascular imaging innovation, announced a pivotal regulatory milestone this week: the U.S. Food and Drug Administration (FDA) has…
FDA Approves Opdivo Plus Yervoy® for Untreated MSI-H or dMMR Metastatic Colorectal Cancer Bristol Myers Squibb today announced a major milestone in cancer immunotherapy with the U.S. Food and Drug Administration (FDA) granting approval for the combination of Opdivo® (nivolumab)…