Haihe Biopharma Wins Japan Approval for Risovalisib – First PI3Kα Inhibitor for Ovarian Clear Cell Carcinoma
Haihe Biopharma Co., Ltd. announced that its independently developed selective PI3Kα inhibitor, Risovalisib Mesylate Tablets,...
Drug
3SBio Wins NMPA Approval for SSS06 – Extended‑Half‑Life Erythropoietin Enables Biweekly Dosing in Dialysis Anemia
3SBio Inc. (HKG: 1530) announced that China’s National Medical Products Administration (NMPA) has approved SSS06,...
Alphamab Oncology Doses First Patient in JSKN016 Phase III – HER3/TROP2 ADC Targets Heavily Pretreated Triple Negative Breast Cancer
Alphamab Oncology (HKG: 9966) announced first patient dosing in a Phase III clinical study for...
Belief BioMed Secures Macao Approval for BBM‑H901 – China’s First Hemophilia B Gene Therapy Expands to Greater China with Takeda
Belief BioMed announced marketing approval from the Pharmaceutical Administration Bureau of Macao Special Administrative Region...
Novo Nordisk Wins FDA Approval for Wegovy HD 7.2 mg – Higher‑Dose Semaglutide Delivers 21% Weight Loss in STEP UP Trial
Novo Nordisk A/S (NYSE: NVO) announced FDA approval of Wegovy HD (semaglutide) 7.2 mg injection,...
Eli Lilly’s Retatrutide Delivers 2.0% A1C Reduction and 36.6 Lbs Weight Loss in Phase 3 Diabetes Trial – Triple‑Agonist Shows Best‑in‑Class Efficacy
Eli Lilly and Company (NYSE: LLY) announced positive topline results from the Phase 3 TRANSCEND‑T2D‑1...
Pfizer Reports Positive TALAPRO-3 Results – TALZENNA/XTANDI Combo Hits Primary Endpoint in HRR-Mutated Prostate Cancer
Pfizer Inc. (NYSE: PFE) announced positive topline results from the Phase 3 TALAPRO-3 study, demonstrating...
Abbisko Therapeutics Wins FDA Orphan Drug Designation for ABSK061 – Oral FGFR2/3 Inhibitor Targets Achondroplasia in Pediatric Patients
Abbisko Therapeutics Co., Ltd. (HKG: 2256) announced that ABSK061 received Orphan Drug Designation (ODD) from...
Huahai Pharmaceutical Initiates Phase III Trial for HB0025 – PD-L1/VEGF Bispecific Targets First-Line Endometrial Cancer
Zhejiang Huahai Pharmaceutical Co., Ltd. (SHA: 600521) announced the initiation of a Phase III clinical...
Konruns Pharma Wins NMPA Phase III Approval for KC1036 – Multi-Target VEGFR2/AXL Inhibitor Targets Thymic Carcinoma
Konruns Pharmaceutical Co., Ltd. (SHA: 603590) received National Medical Products Administration (NMPA) approval to initiate...
InventisBio’s D-2570 Wins FDA Phase II Clearance – Oral TYK2 Inhibitor Targets Moderate-to-Severe Plaque Psoriasis
InventisBio (Shanghai) Co., Ltd. (SHA: 688382) announced FDA clearance to initiate a Phase II clinical...
Kintor Pharma’s KX-826 Hits Phase III Endpoint in Hair Loss – Androgen Receptor Antagonist Tincture Shows 15.33 Hairs/cm² Growth vs. Placebo
Suzhou Kintor Pharmaceuticals, Inc. (HKG: 9939) announced that its pivotal Phase III clinical study for...
J&J’s Icotyde Wins FDA Approval – First Oral IL-23 Receptor Antagonist Targets Moderate-to-Severe Plaque Psoriasis
Johnson & Johnson (J&J, NYSE: JNJ) announced FDA marketing approval for Icotyde (icotrokinra), an interleukin-23...
Sanofi’s Venglustat Wins FDA Breakthrough Therapy Designation – Oral Brain-Penetrant GCSi Targets Gaucher Disease Type 3 Neurological Symptoms
Sanofi (NASDAQ: SNY) announced that venglustat received Breakthrough Therapy Designation (BTD) from the U.S. Food...
TransThera Sciences Doses First Patient in Phase II Tinengotinib Combination Study – Multi-Kinase Inhibitor Plus Fulvestrant Targets HR+/HER2- Breast Cancer
TransThera Sciences (Nanjing), Inc. (HKG: 2617) announced first patient dosing in a Phase II clinical...
Jiuyuan Gene Engineering Secures NMPA Approval for JY47 – SIRPα Antibody Enters MASH Clinical Development
Hangzhou Jiuyuan Gene Engineering Co., Ltd. (HKG: 2566) announced receiving tacit clinical approval from China’s...
Pfizer Reports Positive FOURLIGHT-1 Results for Atirmociclib – CDK4 Inhibitor Shows PFS Benefit in Post-CDK4/6 Breast Cancer
Pfizer Inc. (NYSE: PFE) announced positive topline results from the Phase II FOURLIGHT-1 study, demonstrating...
AstraZeneca Secures EU Approval for Imfinzi in Gastric Cancer – Perioperative Regimen Cuts Death Risk 22% in MATTERHORN Trial
AstraZeneca PLC (NASDAQ: AZN) announced European Union marketing approval for Imfinzi (durvalumab) in combination with...
UniXell Bio Secures FDA Approval for UX‑GIP001 – First iPSC Allogeneic Cell Therapy for Epilepsy Enters US Clinical Trials
Shanghai UniXell Biotechnology Co., Ltd. announced that its iPSC‑derived allogeneic cell therapy UX‑GIP001 has received...
Eli Lilly Rolls Out USD 299 Zepbound KwikPen via LillyDirect – Self‑Pay Pricing for Dual‑Target Obesity Drug
Eli Lilly and Company (NYSE: LLY) announced that patients can now access the single‑patient‑use Zepbound...