EMA Panel Backs Novartis’s Fabhalta for PNH Treatment, Awaits EC Decision
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
Rare / orphan disease drugs
iRegene’s NouvSight001 Gains Orphan Drug Designation for Retinitis Pigmentosa Treatment
Wuhan-based cell therapy innovator iRegene has secured Orphan Drug Designation (ODD) from the U.S. FDA...
Shanghai BDgene Partners with SPH RD to Advance Gene Therapy Development
Shanghai BDgene Technology Co., Ltd., a China-based specialist in gene therapy, has entered into a...
Boehringer Ingelheim’s Spevigo Receives NMPA Approval for GPP Treatment in China
German pharmaceutical giant Boehringer Ingelheim (BI) has announced that it has received marketing approval from...
Novartis Gene Therapy Zolgensma Shows Continued Benefits in Broader SMA Patient Group
Swiss pharmaceutical giant Novartis (NYSE: NVS) has presented Phase III data this week, demonstrating that...
BMS Reports Positive Long-Term Data for Zeposia in Multiple Sclerosis Trials
Bristol Myers Squibb (BMS; NYSE: BMY) has unveiled results from several Phase III trials for...
Merck’s Mavenclad Demonstrates Lasting Efficacy in RMS Patients, New Data Show
Merck KGaA (ETR: MRK), a German multinational pharmaceutical, chemical, and life sciences company, has this...
Hainan Poly Pharm Secures Tentative FDA Approval for Generic Version of UCB’s Briviact
Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it...
CANbridge Pharmaceuticals Partners with Peking Union Medical College to Advance Rare Disease Research
CANbridge Pharmaceuticals Inc. (HKG: 1228), a specialist in rare diseases based in China, has announced...
Jiangsu Nhwa Secures Exclusive Rights to Teva’s Austedo in China with $30 Million Deal
Jiangsu Nhwa Pharmaceutical Co., Ltd. (SHE: 002262), based in China, has entered into a cooperation...
Immune-Onc Therapeutics’ IO-202 Earns Orphan Drug Designation for CMML from US FDA
Immune-Onc Therapeutics, the Hangzhou-based subsidiary of US company Immune-Onc Therapeutics Inc., has announced that it...
MSD’s Belzutifan and Sperogenix’s Vamorolone Targeted for Priority Review by China’s CDE
The Center for Drug Evaluation (CDE) website has indicated that Merck, Sharp & Dohme’s (MSD;...
Biogen Appoints Ding Weibo as Head of Asia-Pacific Region, Succeeding Francis Wan
Biogen (NASDAQ: BIIB) has announced the appointment of Ding Weibo as the new head of...
Hainan Poly Pharm Wins FDA Nod for Generic Version of UCB’s Vimpat
Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it...
Roche’s Piasky (Crovalimab) Secures NMPA Approval for Untreated Paroxysmal Nocturnal Hemoglobinuria
The National Medical Products Administration (NMPA) has granted marketing approval to Swiss pharmaceutical giant Roche...
AstraZeneca Reports 6% Revenue Growth in 2023, Driven by Oncology and Diabetes Drug Sales
AstraZeneca (AZ; NASDAQ: AZN), the UK-based multinational, reported its financial results for 2023 this week,...
European Commission Approves Takeda’s Hyqvia for Chronic Inflammatory Demyelinating Polyneuropathy
The European Commission (EC) has granted regulatory approval to Takeda Pharmaceutical Company Limited (TYO: 4502)...
Astellas Forges Partnership with Mass General Brigham to Boost Oncology and Rare Disease Research
Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced a strategic partnership...
Takeda’s Gammagard Liquid Approved by FDA for Chronic Inflammatory Demyelinating Polyneuropathy
The US Food and Drug Administration (FDA) has granted regulatory approval for Takeda’s (TYO: 4502)...
Shanghai Fosun Pharmaceutical Receives NMPA Approval for Phase II Study of FCN-338 for Light Chain Amyloidosis
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based...