TYK Medicines Submits Pre-NDA Package for Asandeutertinib in NSCLC Brain Metastasis
China-based TYK Medicines, Inc. (HKG: 2410) announced the formal submission of a pre-NDA communication package...
Drug
AbbVie Files BLA for TrenibotE in Moderate to Severe Glabellar Lines Treatment
US-based AbbVie (NYSE: ABBV) announced that it has filed a Biologics License Application (BLA) with...
GenFleet’s KRAS G12D Inhibitor GFH375/VS-7375 Gains FDA Trial Approval
Shanghai-based biotech GenFleet Therapeutics announced that its GFH375/VS-7375, an oral KRAS G12D inhibitor co-developed with...
Innate Pharma and Sanofi Restructure 2016 Research Agreement on CD123 ANKET Drug
France-based Innate Pharma SA has announced a significant adjustment to its 2016 research and licensing...
Hepalink Secures SAHPRA Approval for Ivenoxin in South Africa
Shenzhen Hepalink Pharmaceutical Group Co., Ltd. (SHE: 002399, HKG: 9989) has announced that it has...
Akeso’s Penpulimab Gains FDA Approval for Nasopharyngeal Carcinoma Treatment
China-based Akeso, Inc. (HKG: 9926) announced that it has received marketing approval from the US...
Doer Biologics Begins Phase II Study of DR10624 for Steatotic Liver Disease
China-based Zhejiang Doer Biologics Co., Ltd has announced the first patient dosing in a Phase...
Boehringer Ingelheim Partners with Tessellate Bio on ALT Cancer Therapies
Boehringer Ingelheim (BI), a German pharmaceutical leader, has entered into a strategic collaboration and global...
Baheal Partners with Jiluntai for Commercialization of Technetium-99m-labeled Imaging Agent
China-based health services and distribution giant Baheal Pharmaceutical Group (SHE: 301015) has entered into a...
BMS’s Cobenfy Shows Promise in Phase III ARISE Trial for Schizophrenia
Bristol-Myers Squibb (BMS, NYSE: BMY) has announced top-line results from the Phase III ARISE trial...
CSPC Gains NMPA Approval for Phase III Trial of Prusogliptin/Metformin FDC
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has secured approval from the National Medical Products...
CSPC Pharmaceutical Gains FDA IND Clearance for JMT203 in Cancer Cachexia
China-based CSPC Pharmaceutical Group Limited (HKG: 1093) has obtained Investigational New Drug (IND) clearance from...
Grand Pharma Secures NMPA Approval for Fluticasone Nasal Spray
China-based Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has obtained marketing authorization from China’s National...
Biokin Receives NMPA Approval for CD33 ADC in AML Trial
China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced that it has received approval...
iMBIORAY Gains NMPA Approval for Phase IITrial of IBR854 in Advanced RCC
Hangzhou-based cancer immunotherapy specialist iMBIORAY has received approval from China’s National Medical Products Administration (NMPA)...
Ascletis Pharma Announces Positive Phase Ib Results for ASC30 in Obesity Treatment
China-based Ascletis Pharma Inc. (HKG: 1672) has announced positive top-line results from a Phase Ib...
Akeso’s Ivonescimab Shows Strong Results in Phase III Trial for Sq-NSCLC
China-based Akeso, Inc. (HKG: 9926) announced strongly positive results from the regulatory Phase III AK112-306/HARMONi-6...
BMS Secures NMPA Approval for Opdivo in Resectable NSCLC Neoadjuvant Therapy
Bristol-Myers Squibb (BMS, NYSE: BMY) has announced additional indication approval from China’s National Medical Products...
AstraZeneca’s Ultomiris Approved in China for Generalized Myasthenia Gravis
UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) has announced that the National Medical Products Administration (NMPA)...
Zai Lab’s Augtyro NDA Accepted by China’s NMPA for NTRK Fusion Solid Tumors
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that the supplemental New Drug...