FDA Pilot Program Offers Meeting Minute Clarification to Drug Sponsors
The U.S. Food and Drug Administration (FDA) announced a pilot program designed to streamline post‑meeting...
Reprogenix Closes RMB 500M Series A+ to Advance Diabetes Cell Therapy Pipeline
Reprogenix Bioscience Inc. announced the completion of an oversubscribed RMB 500 million Series A+ financing round led...
Pfizer’s Hympavzi Wins China Approval as First Weekly Non‑Factor Hemophilia Therapy
Pfizer Inc. (NYSE: PFE) announced that Hympavzi (marstacimab), the world’s first non‑factor hemophilia therapy requiring...
Freenome Roche Cancer Screening Deal Worth Over $200M
Freenome, a California‑based early cancer detection company, announced a strategic collaboration with Roche (SWX: ROG,...
Nona Biosciences Licenses HCAb Platform to Pfizer for Antibody Discovery
Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Ltd (HKG: 2142), announced a non‑exclusive licensing...
Rock Roc’s CAR-M Platform Secures RMB 50M Series A for Macrophage Therapy
Rock Roc Biotechnology Co., Ltd completed an oversubscribed RMB 50 million (≈ US$7 million) Series A financing to...
Kelun-Biotech’s Trastuzumab Botidotin HER2 ADC Launches in China After Phase 3 Win vs T-DM1
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced the official China launch of trastuzumab botidotin,...
Regeneron’s Libtayo Wins EC Approval for Adjuvant CSCC, 68% Risk Reduction
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the European Commission (EC) approved Libtayo (cemiplimab) as adjuvant...
Novartis Builds $23B North Carolina Manufacturing Hub, Adding 700 Jobs
Novartis (NYSE: NVS) announced plans to establish a flagship manufacturing hub in North Carolina as...
Lynk’s LNK01004 Pan-JAK Inhibitor Shows EASI-75 Win in Phase 2 Atopic Dermatitis Trial
Lynk Pharmaceuticals Co., Ltd. announced positive Phase II data for its self‑developed Class 1 innovative drug LNK01004,...
Acotec’s Jingyi Balloon Catheter Wins NMPA Approval for Complex Coronary Lesions
Acotec Scientific Holdings Limited (HKG: 6669) announced that China’s National Medical Products Administration (NMPA) has...
Sino Biopharm’s LM-350 CDH17-ADC Wins NMPA Nod for Clinical Trials
Sino Biopharmaceutical Limited (HKG: 1177) announced that its self‑developed LM‑350, a CDH17‑targeting Antibody‑Drug Conjugate (ADC),...
Cutia’s CU-40105 Topical Finasteride Spray NDA Accepted by NMPA, a China First
Cutia Therapeutics (HKG: 2487) announced that the National Medical Products Administration (NMPA) has accepted its...
Mirxes and Walvax Form RNA Partnership for Vaccines and Precision Medicine
Mirxes Holding Company Limited (HKG: 2629) and Walvax Biotechnology Co., Ltd. (300142.SZ) signed a Memorandum...
NMPA Releases 98th RLD Catalog for Chemical Generics, Adding 48 New Specifications
China’s National Medical Products Administration (NMPA) released the ninety-eighth batch of the Reference Listed Drugs...
Roche’s Lunsumio SC Wins EU Conditional Approval for Follicular Lymphoma
Roche Holding AG (SWX: ROG, OTCMKTS: RHHBY) announced that the European Commission (EC) has granted...
Roche’s giredestrant SERD Achieves iDFS Win in Phase 3 lidERA Breast Cancer Trial
Roche (SWX: ROG, OTCMKTS: RHHBY) announced its investigational oral SERD giredestrant met the primary endpoint...
Hengrui’s HRS-6209 CDK4 Inhibitor Wins NMPA Nod for Breast Cancer Combo Trial
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS‑6209 capsules, a novel...
Gate Bioscience Closes $65M Series B to Advance Molecular Gates to Clinic
Gate Bioscience announced the close of its oversubscribed USD 65 million Series B financing led by...
Hengrui’s HRS-4642 KRAS G12D Inhibitor Wins NMPA Nod for Phase 1b/2 Solid Tumor Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS‑4642, a home‑developed KRAS...