United Laboratories’ Biosimilar Semaglutide Accepted for Review by China’s NMPA
Hong Kong-listed United Laboratories International Holdings Ltd (HKG: 3933) has announced that its market filing...
Market approval filings
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...
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...
Zai Lab’s KarXT NDA Accepted by NMPA for Schizophrenia Treatment
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced that a New Drug...
Johnson & Johnson Submits NDA for TAR-200 in High-Risk Bladder Cancer
US-based Johnson & Johnson (J&J, NYSE: JNJ) has announced the initiation of the submission of...
SciClone and Menarini Submit NDA for Vaborem in China
China-based SciClone Pharmaceuticals Inc and its Italy-based strategic partner Menarini have announced the submission of...
Chongqing Genrix’s Silevimig NDA Accepted for Rabies Immunization Review
China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) has announced that a New Drug...
Leqembi Autoinjector Advances with FDA Review for Alzheimer’s Treatment
Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that the...
Bayer Files for Finerenone Approval in US and China for Heart Failure-Fineline Info & Tech
Bayer AG (ETR: BAYN) has announced market filings with the US Food and Drug Administration...
Fosun Pharmaceutical’s FCN-437c Accepted for NMPA Review for Breast Cancer Treatment
Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196) has announced that another market approval...
Hengrui’s SHR4640 Accepted for NMPA Review for Gout and Hyperuricemia Treatment
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that a market filing for...
Bayer’s Nubeqa Seeks NMPA Approval for New Prostate Cancer Indication
Bayer AG (ETR: BAYN) has announced the submission of a supplemental new drug application (sNDA)...
Kelun-Biotech’s Anti-HER2 ADC A166 Receives NMPA Review for Expanded Indication
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that another indication approval filing for...
Aosaikang’s Generic Livtencity Accepted for Review by China’s NMPA
China’s Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has revealed that a market filing for...
WinHealth Pharma’s Difelikefalin Receives NMPA Review for Market Approval
China-based Hong Kong WinHealth Pharma Group has announced that the National Medical Products Administration (NMPA)...
Zhaoke Ophthalmology’s NVK002 ANDA Accepted for Review by China’s NMPA
China-based Lee’s Pharmaceutical Holdings Ltd’s (HKG: 0950) former subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has...
HutchMed’s Orpathys Receives Priority Review for NSCLC Treatment in China
HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that the China National Medical Products...
Auzone Submits NDA for Oral Edaravone TTYP01 to Treat ALS
Auzone Biological Technology has announced the submission of a New Drug Application (NDA) for its...
Pediatrix Therapeutics’ Neffy NDA Accepted by NMPA for Allergy Treatment
China-based Pediatrix Therapeutics has announced that the New Drug Application (NDA) for its neffy (epinephrine...
ProteLight Pharma’s Peceleganan (PL-5) Accepted for Review by China’s CDE
China’s Center for Drug Evaluation (CDE) website has indicated that a market filing by local...