Takeda’s Takhzyro Receives EMA Approval for New Administration Form in HAE Patients
Japan-headquartered Takeda (NYSE: TAK, TYO: 4502) announced that the European Medicines Agency (EMA) has approved...
Rare / orphan disease drugs
Innorna’s IN013 Receives FDA Rare Pediatric Designation for Wilson’s Disease Treatment
Shenzhen-based Innorna Co., Ltd, a platform company leveraging mRNA and lipid nanoparticle (LNP) delivery technologies,...
Gene Cradle and Byongen Therapeutics Partner on Next-Generation DMD Gene Therapies
Gene Cradle and Byongen Therapeutics, both Beijing-based gene therapy specialists, have formed a strategic alliance...
Biogen Licenses Stoke Therapeutics’ Zorevunersen for Dravet Syndrome Outside Americas
US-based Biogen Inc. (NASDAQ: BIIB) has entered into a licensing agreement with Stoke Therapeutics, Inc....
Merck’s Welireg Wins Conditional EU Approval for VHL Disease and Advanced RCC
US pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK) announced that it has received...
Wanbangde New Building Materials’ Mecobalamin Earns FDA Orphan Drug Designation for ALS
China’s Wanbangde New Building Materials Co., Ltd (SHE: 002082) announced that its mecobalamin product has...
Bayer’s Acoramidis (Beyonttra) Gets EMA Marketing Approval for ATTR-CM Treatment in EU
Germany-headquartered Bayer (ETR: BAYN) has received marketing approval from the European Medicines Agency (EMA) for...
Roche Transfers InterMune and Esbriet to Legacy Pharma in IP Deal
Swiss pharma giant Roche (SWX: ROG) has transferred US-based InterMune, Inc., acquired for USD 8...
Sinopep-Allsino Wins NMPA Approval for Generic Liptruzet in China
Jiangsu-based CDMO Sinopep-Allsino Biopharmaceutical Co., Ltd (SHA: 688076) has received marketing approval from China’s National...
Regend Therapeutics’ Pulmovinci Receives FDA Orphan Drug Designation for IPF
Suzhou-based stem cell therapy specialist Regend Therapeutics announced that the US Food and Drug Administration...
Novo Nordisk’s Mim8 Shows Promise in Hemophilia A Trial with 98% Caregiver Preference
Denmark-based Novo Nordisk A/S (NYSE: NVO) released interim results from the Phase III FRONTIER3 study,...
Betta Pharmaceuticals Gains NMPA Approval for BPI-452080 Clinical Study
China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) announced that it has received approval from the...
Sinopharm Partners with Biogen for Comprehensive Service Agreement
China-based Sinopharm Group Co., Ltd (HKG: 1099) has entered into a strategic partnership with US-based...
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...
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...