Roche’s cobas liat STI Assay Panels Gain FDA Approval and CLIA Waiver
Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced receiving approval from the US...
Product approvals
Sanofi’s Sarclisa Approved in EU for Newly Diagnosed Multiple Myeloma
France-based Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving marketing approval in the European Union...
Johnson & Johnson’s Spravato Approved as Monotherapy for Major Depressive Disorder
US-based Johnson & Johnson (J&J; NYSE: JNJ) has announced that its Spravato (esketamine) CIII nasal...
Kehua Bioengineering Gains NMPA Approval for Gene Polymorphism Detection Kits
China-based Shanghai Kehua Bioengineering Co., Ltd (SHE: 002022) has announced receiving marketing approvals from the...
Acotec’s Vericor-S2 Coronary Microcatheter Approved by NMPA
Acotec Scientific Holdings Ltd (HKG: 6669) has announced that its Vericor-S2 coronary microcatheter has received...
NMPA Approves Synaptic Medical’s Cryoablation Device and Gene Methylation Detection Kit
China’s National Medical Products Administration (NMPA) has granted marketing approval for two new medical devices:...
GSK’s Jemperli Approved for First-Line Endometrial Cancer Treatment in EU
UK-based GSK plc (NYSE: GSK, LON: GSK) has announced receiving approval from the European Commission...
Kelun-Biotech’s Tagitanlimab Receives NMPA Clearance for Nasopharyngeal Carcinoma
China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced receiving another clearance from the...
Chongqing Genrix’s Xeligekimab Approved for Ankylosing Spondylitis by NMPA
China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd (SHA: 688443) has announced receiving approval from the...
FDA Approves AstraZeneca’s Calquence for Mantle Cell Lymphoma
UK-based pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) last week revealed that the US Food and...
MHRA Approves Gilead’s Livdelzi for Primary Biliary Cholangitis
The Medicines and Healthcare products Regulatory Agency (MHRA) last week signed off on US-based Gilead...
FDA Clears Amgen’s Lumakras and Vectibix Combo for KRAS G12C-mutated mCRC
US-based Amgen (NASDAQ: AMGN) has announced receiving clearance from the US Food and Drug Administration...
FDA Approves Datroway for HR+/HER2- Breast Cancer Treatment
Datroway (datopotamab deruxtecan-dlnk, Dato-Dxd), a Trop-2-directed antibody and topoisomerase inhibitor conjugate co-developed by Japan-based Daiichi...
Junshi Biosciences’ Toripalimab Gains TGA Approval for Nasopharyngeal Carcinoma
China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving marketing approval...
Aosaikang’s Limertinib Approved for EGFR T790M-Mutated NSCLC
Jiangsu Aosaikang Pharmaceutical Co., Ltd (ASK Pharm, SHE: 002755) has recently received approval from the...
Eli Lilly’s Omvoh Approved by FDA for Crohn’s Disease Treatment
US major Eli Lilly and Company (NYSE: LLY) has announced receiving marketing approval from the...
Telix Pharmaceuticals’ TLX591-CDx Approved in Europe via Decentralized Procedure
Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) has announced that the marketing filing in Europe via...
Impact Therapeutics’ Senaparib Cleared by NMPA for Ovarian Cancer Therapy
China-based Impact Therapeutics has announced receiving marketing clearance from the National Medical Products Administration (NMPA)...
Innovent’s Limertinib Wins NMPA Approval for NSCLC Treatment
China-based Innovent Biologics, Inc. (HKG: 1801) has announced that it has received New Drug Application...
HutchMed’s Orpathys Approved for Expanded NSCLC Indication in China
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that the National Medical Products Administration...