D3 Bio’s KRAS Programs Advance: FDA Clears Phase I G12D Inhibitor D3S‑003 and Phase II G12C‑ERK Combo
D3 Bio announced FDA clearance for two clinical programs: a Phase I first‑in‑human study for D3S‑003,...
Company
Aidea’s ADC205 HIV Combo Gets NMPA Nod for Clinical Trials, Targeting $2.8B Market
Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) announced that China’s National Medical Products Administration (NMPA)...
Blue Sail’s Lithonic IVL System Wins CE Mark for Coronary Calcified Lesions
Blue Sail Medical Co., Ltd (SHE: 002382) announced that its Lithonic coronary intravascular shockwave therapy...
Shionogi’s Fetroja Wins China NMPA Approval for Complicated UTIs, Targets Resistant Gram‑Negative Infections
Shionogi Co., Ltd announced that China’s National Medical Products Administration (NMPA) has granted marketing approval...
Chiesi’s Raxone Begins LHON Treatment in China, First World‑Approved Therapy
Chiesi Group announced that the first patients have initiated treatment with Raxone (idebenone 150 mg) at...
EasyDiagnosis Bio to Acquire 51% of Ailex Medical in $5.1M Deal, Gains IVD Platform
Wuhan EasyDiagnosis Biomedicine Co., Ltd (SHE: 002932) announced plans to acquire a 51% stake in...
AstraZeneca Secures Full Global Rights to AbelZeta’s C‑CAR031 in $630M CAR‑T Deal
AbelZeta Pharma, Inc. (Sino‑US biotech) announced an agreement with AstraZeneca (AZ, NASDAQ: AZN) granting AZ the...
Novartis’s Ianalumab Wins FDA Breakthrough Therapy Designation for Sjögren’s Disease
Novartis AG (NYSE: NVS) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough...
Medtronic and Precision Neuroscience Form First Brain‑Device Alliance to Access Neural Data
Medtronic plc (NYSE: MDT) announced a partnership with Precision Neuroscience Corp., marking the first public alliance...
Akeso’s Gumokimab NMPA Filing for Ankylosing Spondylitis Expands IL‑17A Franchise
Akeso Biopharma (HKG: 9926) announced that the Center for Drug Evaluation (CDE) of NMPA has...
Harbour BioMed Boosts Spruce Stake to 3.8%, Advancing SPR202 for Adrenal Disease
Harbour BioMed (HKG: 2142) announced it has exercised warrants to acquire additional common stock in Spruce...
Duality’s DB‑1317 ADC Receives IND Approval for ADAM9‑Targeted Solid Tumor Therapy
Duality Biologics (HKG: 9606) announced that its ADAM9‑targeting ADC candidate DB‑1317 has received Investigational New...
Biogen’s High‑Dose SPINRAZA Wins EU Approval for 5q SMA After Japan Nod
Biogen Inc. (NASDAQ: BIIB) announced that the European Commission (EC) has granted marketing authorization for a...
InventisBio Files for Hong Kong IPO, Betting on Oncology and Metabolic Pipeline
InventisBio Co., Limited (SHA: 688382) this week filed for an initial public offering (IPO) to...
Boston Scientific to Acquire Penumbra in $14.5 Billion Deal, Bolsters Thrombectomy Leadership
Boston Scientific Corporation (NYSE: BSX) and Penumbra, Inc. (NYSE: PEN) announced a definitive agreement for Boston Scientific...
Gan & Lee’s Insulin Glargine Wins Ethiopia Approval, Challenging Sanofi’s Dominance
Gan & Lee Pharmaceuticals (SHA: 603087) announced that its insulin glargine injection and pre‑filled insulin...
Zelgen’s ZGGS18 & ZG005 Cleared by NMPA for Advanced Solid Tumor Studies
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that China’s National Medical Products Administration (NMPA)...
J&J MedTech Partners with CED Medical to Accelerate Neurovascular Intervention Solutions
Johnson & Johnson MedTech announced a strategic partnership with CED Medical, building on their 2023...
Signet Therapeutics Completes Preclinical Study for SIGX2649, Pan‑TEAD Inhibitor for Solid Tumors
Signet Therapeutics, incubated by Xtalpi Inc. (HKG: 2228), announced completion of preclinical studies for SIGX2649,...
Vitalgen’s VGN‑R08b Gene Therapy Earns FDA Orphan Drug Designation for Gaucher Disease
Shanghai Vitalgen BioPharma Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has...