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...
Market approval filings
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...
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,...
SinoMab BioScience’s Suciraslimab Files for Market Approval in China for Rheumatoid Arthritis
Hong Kong-based biotech company SinoMab BioScience Ltd (HKG: 3681) has announced that a market approval...
Sihuan Pharmaceutical’s Birociclib NDA Accepted for Review by China’s NMPA
China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that the National Medical Products...
Japan’s MHLW Reviews GSK’s Nucala for Chronic Rhinosinusitis with Nasal Polyps Indication
The Ministry of Health, Labour and Welfare (MHLW) in Japan has begun the review process...
AstraZeneca and Daiichi Sankyo’s Enhertu Earns Two BTDs for HER2+ Malignancies
The US Food and Drug Administration (FDA) has granted AstraZeneca (AZ; NASDAQ: AZN) and Daiichi...
EMA and FDA Review AbbVie’s Skyrizi for Ulcerative Colitis Indication Extension
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have accepted...
Janssen Submits Indication Extension Application for Balversa in Urothelial Carcinoma Treatment
The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has submitted an indication extension...
Janssen Submits Rybrevant for FDA Review as First-Line NSCLC Treatment
Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has submitted an additional indication for review...
Jiangsu Hengrui Submits Market Approval Filing for SHR0302 in Ankylosing Spondylitis
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that a market approval filing...
Junshi Biosciences’ Senaparib NDA Accepted by NMPA for Ovarian Cancer Maintenance Treatment
China’s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced that the New Drug Application (NDA)...
Everest Medicines’ Nefecon NDA for IgAN Accepted for Review in Macao
China-based Everest Medicines (HKG: 1952) has announced that its New Drug Application (NDA) for Nefecon,...
Akeso Biopharma’s Ebdarokimab (AK101) NDA Accepted for Review by China’s CDE
China-based Akeso Biopharma (HKG: 9926) has announced that the New Drug Application (NDA) for its...
FDA Grants Priority Review to Pfizer and Astellas’ Xtandi for High-Risk Prostate Cancer
The US Food and Drug Administration (FDA) has granted priority review status to the submission...
RemeGen’s Telitacicept Shows Positive Phase III Results in Rheumatoid Arthritis Study
China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has announced positive results from the China...
Jiangsu Hengrui Pharmaceuticals’ Fluzoparib Files for New Indication with China’s NMPA
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that the National Medical Products...
Luye Pharma Group Submits Market Approval Filing for Lurbinectedin in Metastatic SCLC in Macau
China-based Luye Pharma Group (HKG: 2186) has announced that a market approval filing has been...
Amgen’s Lumakras Faces Full Registration Review by FDA for KRAS-Mutated NSCLC
The US Food and Drug Administration (FDA) is scheduled to review an application submitted by...
Simcere Pharmaceutical’s Cosela Receives NMPA Review for ES-SCLC Indication
China-based Simcere Pharmaceutical Group (HKG: 2096) has announced that the National Medical Products Administration (NMPA)...