Boehringer Ingelheim’s Nerandomilast Granted Priority Review for IPF in China
German pharmaceutical giant Boehringer Ingelheim has announced that the Center for Drug Evaluation (CDE) of...
Rare / orphan disease drugs
Biogen’s Higher-Dose Spinraza Regimen Under Review by FDA and EMA
US-based biopharmaceutical company Biogen (NASDAQ: BIIB) has submitted supplemental New Drug Applications (sNDAs) to the...
Novo Nordisk Partners with IMMvention on BACH1 Program for Sickle Cell Disease
Denmark-based Novo Nordisk A/S (NYSE: NVO) has entered into a strategic collaboration and license agreement...
Zai Lab’s ZL-1310 Granted Orphan Drug Designation by FDA for SCLC
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced that the US Food...
Haisco’s HSK44459 Approved for Clinical Trials in Behcet’s Disease
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced receiving clinical trial approval from...
Arrowhead’s Plozasiran Accepted for FDA Review in Familial Chylomicronemia Syndrome
US-based Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) has announced that the New Drug Application (NDA) for...
Wepon Medical’s WP107 Receives FDA Approval for gMG Clinical Trial
China-based Wepon Medical Holding Group Co., Ltd. (SHE: 002082) has announced receiving clinical trial approval...
Mediar Therapeutics and Eli Lilly Ink Deal for IPF Drug MTX-463
US-based clinical-stage biotech Mediar Therapeutics, Inc. has announced a global license agreement with Eli Lilly...
Samsung Bioepis and Teva Partner on Biosimilar EPYLLI for US Market
South Korea’s Samsung Bioepis and Israel-based Teva Pharmaceutical (NYSE: TEVA) have entered into a license,...
Sinogen’s SalMet-Vec Receives FDA Orphan Drug Designation for Pancreatic Cancer
China’s oncology specialist Guangzhou Sinogen Pharmaceutical Co., Ltd. has announced receiving Orphan Drug Designation (ODD)...
FDA Grants Priority Review to Johnson & Johnson’s Nipocalimab for Myasthenia Gravis
US-based Johnson & Johnson (J&J, NYSE: JNJ) has announced that the US FDA has granted...
Alchemab Therapeutics Partners with Eli Lilly to Discover ALS Treatments
UK-based Alchemab Therapeutics has formed a strategic partnership with US major Eli Lilly & Co....
HuidaGene Therapeutics Receives EMA Orphan Designation for HG004 Gene Therapy
Shanghai-based genome medicines specialist HuidaGene Therapeutics has announced a positive opinion from the European Medicines...
Takeda and Fudan University’s IMI Launch AI-Based Rare Disease Screening and Diagnosis Project
Japan-headquartered Takeda (TYO: 4502) and the Intelligent Medicine Institute (IMI) at Fudan University have jointly...
Novartis Announces Positive Results from Phase III STEER Study on SMA Treatment
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced positive topline results from the Phase III...
MicuRx Pharmaceuticals’ MRX-5 Receives FDA Orphan Drug Designation for NTM Infections
Sino-US firm MicuRx Pharmaceuticals Inc. has announced that the US Food and Drug Administration (FDA)...
argenx’s Vygart Hytrulo Approved in Japan for Chronic Inflammatory Demyelinating Polyneuropathy
Holland-based argenx SE (NASDAQ: ARGX) has announced receiving another indication approval from Japan’s Ministry of...
Sanofi and Corxel Pharmaceuticals Partner for Aficamten in Greater China Rights
Global healthcare leader Sanofi (NASDAQ: SNY) and China-based Corxel Pharmaceuticals (CORXEL), formerly known as Ji...
Sino Biopharmaceutical Ltd. Files for Benmelstobart and Anlotinib Combination Therapy in ASPS Treatment
China-based Sino Biopharmaceutical Ltd (HKG: 1177) is poised to make another indication approval filing with...
AstraZeneca’s ALXN2350 Selected for CDE’s Rare Disease Drug Development Program
The Center for Drug Evaluation (CDE) in China has announced its intention to include AstraZeneca’s...