Akeso's Ivonescimab Receives Breakthrough Therapy Designation in China for Triple-Negative Breast Cancer
Akeso's ivonescimab, a PD-1/VEGF bispecific antibody, has been granted Breakthrough Therapy Designation (BTD) by China's National Medical Products Adm...
November 3, 2025
Vizient Applauds FDA Actions to Accelerate Biosimilar Development and Lower Costs
Vizient commends the FDA for announcing actions to accelerate biosimilar development, including releasing new draft guidance that provides greater cla...
October 31, 2025
FDA Approves Updated Indication for WINREVAIR™ (sotatercept-csrk) for Pulmonary Arterial Hypertension Based on Phase 3 ZENITH Study
Merck announced that the FDA has approved an update to the U.S. product label for WINREVAIR™ (sotatercept-csrk) based on the Phase 3 ZENITH trial. The...
October 27, 2025
FDA Approves Genentech's Gazyva for Lupus Nephritis Treatment
The FDA has approved Genentech's Gazyva (obinutuzumab) for treating adult patients with active lupus nephritis (LN) receiving standard therapy. The ap...
October 20, 2025
OS Therapies Receives FDA and MHRA Feedback on OST-HER2 for Metastatic Osteosarcoma
OS Therapies Inc. announced that the FDA granted a Type C meeting to discuss clinical efficacy data endpoints for a BLA under the Accelerated Approval...
October 17, 2025
Civica to Launch Affordable Long-Acting Insulin Glargine in the US
Non-profit pharmaceutical company Civica is set to launch a long-acting insulin, insulin glargine-yfgn, in pre-filled pens at the lowest list price in...
October 16, 2025
Palisade Bio Receives Canadian Patent for PALI-2108 Composition
Palisade Bio announced that the Canadian Intellectual Property Office has granted patent number 3,174,137 for the composition of PALI-2108, its orally...
October 14, 2025
MannKind Announces FDA Acceptance of sBLA for Afrezza in Pediatric Diabetes Patients
MannKind Corporation announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Afrezza (insulin human) Inhalation ...
October 14, 2025
Bicara Therapeutics Receives FDA Breakthrough Therapy Designation for Ficerafusp Alfa in 1L HPV-Negative R/M HNSCC
Bicara Therapeutics announced that the FDA has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for...
October 14, 2025
FDA Approves Boehringer Ingelheim's Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis
The U.S. FDA has approved Boehringer Ingelheim's JASCAYD® (nerandomilast) tablets as the first new treatment option in over a decade for adults with I...
October 9, 2025
Spruce Biosciences Receives FDA Breakthrough Therapy Designation for Tralesinidase Alfa for Sanfilippo Syndrome Type B
Spruce Biosciences received Breakthrough Therapy Designation from the FDA for tralesinidase alfa enzyme replacement therapy (TA-ERT) for the treatment...
