United Laboratories Receives Tacit Approval for JAK1 Inhibitor TUL01101 Clinical Trial
Hong Kong-listed United Laboratories International Holdings Ltd (HKG: 3933) has announced tacit clinical trial approval...
Drug
Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Phase Ib/III Study of Dalpiciclib in mHSPC
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval...
Roche and Alnylam’s Zilebesiran Achieves Primary Endpoint in Hypertension Phase II Trial
Roche (SWX: ROG) and Alnylam (NASDAQ: ALNY) have announced that a Phase II trial for...
Pfizer and Valneva’s Lyme Disease Vaccine VLA15 Shows Promise as Booster in Pediatric Trials
Partners Pfizer (NYSE: PFE) and Valneva SE (NASDAQ: VALN) have revealed that their Lyme disease...
European Commission Approves Pediatric Indication for MSD’s Ervebo Ebola Vaccine
The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) approval for...
Cutia Therapeutics’ CU-40102 Meets Primary Endpoint in Phase III Study for Androgenic Alopecia
Dermatology therapy developer Cutia Therapeutics (HKG: 2487) has announced that its Phase III clinical study...
AstraZeneca’s Ultomiris Faces FDA Rejection for NMOSD Indication Extension
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has received a rejection from the US Food...
Chengdu Kanghua Receives FDA Approval for Clinical Trial of Norovirus Vaccine
China-based Chengdu Kanghua Biological Products Co., Ltd (SHE: 300841) has announced that it has received...
Merck’s Keytruda Approved in China for MSI-H/dMMR Advanced Solid Tumors: A Biomarker-Driven Milestone
US pharmaceutical major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its programmed...
Immunofoco’s IMC008 Earns Orphan Drug Designation for Pancreatic Cancer from FDA
Suzhou-based cell therapy developer Immunofoco has announced that it has received orphan drug designation (ODD)...
Shanghai Haihe Pharmaceutical’s Glumetinib Filed for Marketing in Japan for NSCLC Treatment
Shanghai Haihe Pharmaceutical Co., Ltd has announced the filing for marketing approval in Japan for...
Luye Pharma’s Botawei Receives NMPA Approval for Breast Cancer Treatment
Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the...
Janssen’s Rybrevant Combo Meets Primary Endpoint in Advanced NSCLC Study
Janssen, a subsidiary of Johnson & Johnson (J&J; NYSE: JNJ), has released an update on...
Henan Zhongshuai’s Dexmethylphenidate Hydrochloride Capsules Target Priority Review for Pediatric ADHD
Henan Zhongshuai Pharmaceutical Co., Ltd., a China-based pharmaceutical company, is poised to secure priority review...
Amneal Pharmaceuticals Receives China Approval for Sevelamer Carbonate
US-based Amneal Pharmaceuticals Inc. (NYSE: AMRX) has announced that it has received approval from the...
CSPC Pharmaceutical’s Narlumosbart Approved by NMPA for Bone Giant Cell Tumors
CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its subsidiary, Shanghai JMT Biotechnology Co.,...
Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for CDE’s BTD Status
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its HER2 targeted antibody-drug...
Genentech Files for FDA Approval of Crovalimab for PNH, Challenging Soliris
Swiss pharmaceutical giant Roche’s subsidiary, Genentech (SWX: ROG), has submitted its anti-C5 investigational drug, crovalimab,...
Hainan Haiyao Concludes Phase I Clinical Study for PaiEnJiaBin, a Novel KCNQ Agonist
China-based Hainan Haiyao Co., Ltd (SHE: 000566) has announced the conclusion of Phase I clinical...
Brii Biosciences Announces Positive Interim Data for BRII-179 Vaccine in Chronic Hepatitis B
China-based Brii Biosciences Ltd (HKG: 2137) has announced topline cohort-level unblinded Week 36 data from...