Product approvals

China NMPA Approves World’s First Invasive BCI Medical Device – Brain-Computer Interface Hand Motor System Targets Spinal Cord Injury Patients

China’s National Medical Products Administration (NMPA) granted registration approval for the “Implantable Brain-Computer Interface Hand...

Company Drug

J&J’s AKEEGA Wins EU Approval for mHSPC – PARP/Abiraterone Combo Expands to Earlier-Line Prostate Cancer

Fineline Cube Mar 11, 2026

Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has approved a...

Company Drug

FDA Approves GSK’s Wellcovorin for Cerebral Folate Deficiency – First Treatment for Rare FOLR1 Genetic Disorder

Fineline Cube Mar 11, 2026

The U.S. Food and Drug Administration (FDA) approved expanded use of GlaxoSmithKline’s (GSK, NYSE: GSK)...

Company Drug

Bristol-Myers Squibb’s Sotyktu Wins FDA Label Extension – TYK2 Inhibitor Expands to Psoriatic Arthritis

Fineline Cube Mar 9, 2026

Bristol-Myers Squibb (BMS, NYSE: BMY) announced FDA approval for a label extension of Sotyktu (deucravacitinib),...

Company Drug

Novo Nordisk’s IcoSema Wins NMPA Approval – Once-Weekly Insulin-Semaglutide Combo Targets China Type 2 Diabetes Market

Fineline Cube Mar 9, 2026

Novo Nordisk A/S (NYSE: NVO) secured NMPA approval for IcoSema, a once-weekly fixed-dose combination of...

Company Drug

Sciwind’s Ecnoglutide Wins NMPA Approval for Weight Loss – World’s First cAMP-Biased GLP-1 Agonist Targets China Obesity Market

Fineline Cube Mar 6, 2026

Sciwind Biosciences announced that Ecnoglutide injection (Xianweiying), the world’s first cAMP-biased GLP-1 receptor agonist, has...

Company Drug

J&J’s TECVAYLI Wins FDA Approval in Earlier-Line Myeloma – BCMA BiTE Plus Daratumumab Combo Expands Addressable Market

Fineline Cube Mar 6, 2026

Johnson & Johnson (J&J, NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA)...

Medical Device

Sanyou Medical’s 3D‑Printed SWINGO-3D Lumbar Cage Wins FDA 510(K) – Advances Spinal Fusion Technology

Fineline Cube Mar 5, 2026

Sanyou Medical (SHA: 688085) announced that its French subsidiary Implanet has received FDA 510(K) clearance for...

Company Drug

Sihuan Pharma’s Bireociclib Wins NMPA Approval for First‑Line HR+/HER2‑ Breast Cancer – CDK2/4/6 Inhibitor Expands Label

Fineline Cube Mar 4, 2026

Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that Xuanyuening (bireociclib), a Category 1 CDK2/4/6 inhibitor developed...

Company Drug

Bio-Thera’s Stelara Biosimilar Usymro Wins UK Approval – Expands European Market Access via Gedeon Richter

Fineline Cube Mar 4, 2026

Bio-Thera Solutions Ltd (SHA: 688177) announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA)...

Company Drug Medical Device

Asieris Pharma’s Cevira Wins NMPA Approval – World’s First Non‑Surgical Photodynamic Therapy for Cervical Lesions

Fineline Cube Mar 4, 2026

Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176), a urogenital cancer specialist, announced marketing approval from China’s...

Company Drug

Hua Medicine’s Dorzagliatin Wins Hong Kong Approval – First‑in‑Class GKA Enters Market for Type 2 Diabetes

Fineline Cube Mar 3, 2026

Hua Medicine (HKG: 2552) announced that the Department of Health in Hong Kong has approved HuaTangNing...

Company Drug

Sino Biopharma’s Rovadicitinib Wins NMPA Approval – First‑in‑Class JAK/ROCK Inhibitor for Myelofibrosis

Fineline Cube Mar 2, 2026

Sino Biopharmaceutical Limited (HKG: 1177) announced that the National Medical Products Administration (NMPA) has approved rovadicitinib...

Company Drug

Hangyu Pharma’s Sosimerasib Wins NMPA Approval – First KRAS G12C Inhibitor for Post‑Therapy NSCLC in China

Fineline Cube Mar 2, 2026

Zhejiang Hangyu Pharmaceutical Co., Ltd., a subsidiary of Jemincare, announced that China’s National Medical Products...

Company Drug

Dupixent Wins Two NMPA Approvals in China – First Biologic for Bullous Pemphigoid and Pediatric Asthma Expansion

Fineline Cube Feb 28, 2026

Sanofi (NASDAQ: SNY) announced that Dupixent (dupilumab) has been approved by China’s National Medical Products Administration...

Company Drug

Olumiant Wins CHMP Positive Opinion for Pediatric Alopecia – JAK Inhibitor Nears EU Approval for Teens with Severe AA

Fineline Cube Feb 28, 2026

Eli Lilly (NYSE: LLY) and Incyte (NASDAQ: INCY) announced that the European Medicines Agency’s (EMA) Committee for...

Company Drug

FDA Approves Boehringer’s Zongertinib in Record 44 Days – First Oral HER2 TKI Wins CNPV Fast‑Track

Fineline Cube Feb 27, 2026

The U.S. Food and Drug Administration (FDA) approved zongertinib (Hernexeos), developed by Boehringer Ingelheim, in...

Company Drug

FDA Approves AstraZeneca’s Calquence Plus Venetoclax for CLL/SLL – First All‑Oral Fixed‑Duration Regimen

Fineline Cube Feb 25, 2026

AstraZeneca (AZ, NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) has approved the...

Company Drug

Dupixent Wins FDA Approval for Allergic Fungal Rhinosinusitis – First Targeted Therapy for AFRS Expands Dupilumab Label

Fineline Cube Feb 25, 2026

Sanofi (NASDAQ: SNY) and Regeneron (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has...

Company Drug

CanSino Biologics Wins NMPA Approval for Menhycia Age Expansion – MCV4 Now Covers Children Up to 6 Years

Fineline Cube Feb 25, 2026

CanSino Biologics (HKG: 6185) announced that China’s National Medical Products Administration (NMPA) has approved a supplementary...

Product approvals

China NMPA Approves World’s First Invasive BCI Medical Device – Brain-Computer Interface Hand Motor System Targets Spinal Cord Injury Patients

J&J’s AKEEGA Wins EU Approval for mHSPC – PARP/Abiraterone Combo Expands to Earlier-Line Prostate Cancer

FDA Approves GSK’s Wellcovorin for Cerebral Folate Deficiency – First Treatment for Rare FOLR1 Genetic Disorder

Bristol-Myers Squibb’s Sotyktu Wins FDA Label Extension – TYK2 Inhibitor Expands to Psoriatic Arthritis

Novo Nordisk’s IcoSema Wins NMPA Approval – Once-Weekly Insulin-Semaglutide Combo Targets China Type 2 Diabetes Market

Sciwind’s Ecnoglutide Wins NMPA Approval for Weight Loss – World’s First cAMP-Biased GLP-1 Agonist Targets China Obesity Market

J&J’s TECVAYLI Wins FDA Approval in Earlier-Line Myeloma – BCMA BiTE Plus Daratumumab Combo Expands Addressable Market

Sanyou Medical’s 3D‑Printed SWINGO-3D Lumbar Cage Wins FDA 510(K) – Advances Spinal Fusion Technology

Sihuan Pharma’s Bireociclib Wins NMPA Approval for First‑Line HR+/HER2‑ Breast Cancer – CDK2/4/6 Inhibitor Expands Label

Bio-Thera’s Stelara Biosimilar Usymro Wins UK Approval – Expands European Market Access via Gedeon Richter

Asieris Pharma’s Cevira Wins NMPA Approval – World’s First Non‑Surgical Photodynamic Therapy for Cervical Lesions

Hua Medicine’s Dorzagliatin Wins Hong Kong Approval – First‑in‑Class GKA Enters Market for Type 2 Diabetes

Sino Biopharma’s Rovadicitinib Wins NMPA Approval – First‑in‑Class JAK/ROCK Inhibitor for Myelofibrosis

Hangyu Pharma’s Sosimerasib Wins NMPA Approval – First KRAS G12C Inhibitor for Post‑Therapy NSCLC in China

Dupixent Wins Two NMPA Approvals in China – First Biologic for Bullous Pemphigoid and Pediatric Asthma Expansion

Olumiant Wins CHMP Positive Opinion for Pediatric Alopecia – JAK Inhibitor Nears EU Approval for Teens with Severe AA

FDA Approves Boehringer’s Zongertinib in Record 44 Days – First Oral HER2 TKI Wins CNPV Fast‑Track

FDA Approves AstraZeneca’s Calquence Plus Venetoclax for CLL/SLL – First All‑Oral Fixed‑Duration Regimen

Dupixent Wins FDA Approval for Allergic Fungal Rhinosinusitis – First Targeted Therapy for AFRS Expands Dupilumab Label

CanSino Biologics Wins NMPA Approval for Menhycia Age Expansion – MCV4 Now Covers Children Up to 6 Years

You Missed

Kintor Pharmaceutical Partners with Fonow Medicine – KT-939 Cosmetic Collaboration Targets China Whitening and Melasma Market

Sino Biopharm’s TQB3454 Hits Phase III Endpoints in IDH1+ Biliary Tract Cancer – China’s First IDH1 Inhibitor Poised for NDA Filing

CMS Launches Opzelura Nationwide – First Topical JAK Inhibitor for Vitiligo Reaches 1,300+ Pharmacies Across 30 Chinese Provinces

Essight Bio’s ES502 Wins FDA Phase I Approval – First TCR×CD3 Bispecific Targeting RAS G12V Mutations Enters Clinic