Regeneron Secures FDA Approval for Otarmeni Gene Therapy and Announces Landmark U.S. Pricing Agreement
Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has...
Product approvals
FDA Expands Sanofi’s Tzield Approval to Children as Young as One Year Old for Type 1 Diabetes Prevention
The U.S. Food and Drug Administration (FDA) has approved a supplemental biologics license application for...
European Commission Grants Conditional Approval to Ipsen’s Ojemda (Tovorafenib) for Pediatric Low-Grade Glioma with BRAF Alterations
Ipsen S.A. (EPA: IPN, OTCMKTS: IPSEY) announced on April 22, 2026, that the European Commission...
Johnson & Johnson Secures CE Mark for Advanced ETHICON 4000 Surgical Stapler with Proprietary 3D Stapling Technology
Johnson & Johnson (J&J, NYSE: JNJ) announced on April 22, 2026, that it has received...
FDA Approves Sanofi-Regeneron’s Dupilumab for Pediatric Chronic Spontaneous Urticaria in Children Aged 2–11 Years
The U.S. Food and Drug Administration (FDA) has granted approval to Sanofi (NASDAQ: SNY) and...
Merck’s Idvynso Gains FDA Approval as Novel Dual-Drug HIV Treatment
Merck & Co., Inc. (MSD, NYSE: MRK) announced that the U.S. Food and Drug Administration...
LEO Pharma Secures NMPA Approval for Enstilar Foam in China – First and Only Calcipotriol/Betamethasone Foam Formulation for Plaque Psoriasis Demonstrates Superior Efficacy vs. Ointment
LEO Pharma A/S has received marketing approval from China’s National Medical Products Administration (NMPA) for...
Sino Biopharmaceutical’s Subsidiary Chia Tai Tianqing Secures NMPA Approval for Benmelstobart-Anlotinib Combo in Alveolar Soft Part Sarcoma – 72.4% ORR and Unreached Median PFS in Rare Cancer Indication
The National Medical Products Administration (NMPA) has granted approval to Chia Tai Tianqing Pharmaceutical Co.,...
Sunshine Lake Pharma Secures NMPA Approval for In-House Developed Premixed Insulin 30R Prefilled Pen
Sunshine Lake Pharma Co., Ltd. (HKG: 6887) announced that its in-house developed isophane protamine recombinant...
WinHealth Pharma Secures NMPA Approval for Korsuva (Difelikefalin) to Treat CKD-Associated Pruritus in Chinese Hemodialysis Patients
Hong Kong WinHealth Pharma Group announced that China’s National Medical Products Administration (NMPA) has granted...
Mabwell Bioscience Secures Second NMPA Approval for Denosu, China’s First Xgeva Biosimilar, Expanding Indication to Bone Metastasis and Multiple Myeloma
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced a second indication approval from China’s...
UCB Secures EU Approval for Kygevvi as First-Ever Treatment for Ultra-Rare TK2 Deficiency
UCB (EBR: UCB) announced that the European Commission (EC) has granted marketing approval under exceptional...
Roche’s Elecsys NfL Test Gains CE Mark for Blood-Based Multiple Sclerosis Neuroinflammation Monitoring
Roche AG (SWX: ROG, OTCMKTS: RHHBY) announced on 13 April 2026 that its Elecsys Neurofilament...
Sanofi Secures EC Approval for Dupixent in Pediatric Chronic Spontaneous Urticaria – First Biologic Therapy for Children 2–11 Years
Sanofi SA (NASDAQ: SNY) announced that the European Commission (EC) has granted marketing authorization for...
AstraZeneca’s Imjudo Gains NMPA Approval for First-Line NSCLC in China, Backed by POSEIDON Data
AstraZeneca plc (NYSE: AZN) has secured marketing approval from China’s National Medical Products Administration (NMPA)...
RemeGen’s Disitamab Vedotin Wins World’s First HER2-ADC Approval for First-Line Advanced Urothelial Carcinoma
RemeGen Ltd. (HKG: 9995) has announced that China’s National Medical Products Administration (NMPA) has approved...
AbbVie Secures NMPA Label Expansion for Rinvoq in China, Clarifying Use in UC and Crohn’s Disease
AbbVie Inc. (NYSE: ABBV) has announced that China’s National Medical Products Administration (NMPA) has approved...
CanSino Biologics Secures NMPA Approval for Pankangxin, China’s First Three-Component Acellular DTaP Vaccine
CanSino Biologics Inc. (HKG: 6185) has announced that China’s National Medical Products Administration (NMPA) has...
Gaush Meditech Secures CE Mark for Corneal Confocal Microscope, Paving Way for EU Commercial Launch
Gaush Meditech Ltd. (HKG: 2407), a Chinese innovator in ophthalmic medical devices, has announced it...
Henlius Biotech Secures Two New NMPA Approvals for Hanlikang – Expands Rituximab Biosimilar into DLBCL Combination Therapies
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has granted...