Tecelra (afamitresgene autoleucel), a gene therapy, has been approved by the FDA for treating adults with unresectable or metastatic synovial sarcoma. Patients must have received prior chemotherapy, be positive for specific HLA antigens, and have...
European Medicines Agency (EMA) initiated a pilot program for expert panels to assist in the creation and evaluation of rare medical devices in the EU. The pilot program provides free guidance from medical device expert panels to specific...
Chugai Pharmaceutical Co., Ltd. reported the announcement of Chugai Pharma Taiwan Ltd. Chugai's subsidiary CPT received a license from TFDA to import Alecensa for ALK-positive NSCLC patients post-tumour resection. CPT manages the development...
MiRus, a company in the life sciences industry, has been granted Breakthrough Device Designation by the FDA for its EUROPA Posterior Cervical System, which uses its unique rhenium alloys, to treat issues in the cervical and upper thoracic spine...
NeuroBo Pharmaceuticals, Inc., a biotech company in the clinical stage that specializes in addressing cardiometabolic diseases, revealed the completion of a unique licensing deal with MThera Pharma Co., Ltd. (MTHERA) has the rights to NB-01 for...
Sanofi, a pharmaceutical company from France, announced that the Central Drugs Standard Control Organization (CDSCO) in India has approved the marketing of their new treatment Beyfortus for newborns and infants with respiratory syncytial virus...
Johnson & Johnson stated that the FDA has given approval for Darzalex Faspro to be used in combination with D-VRd for induction and consolidation in eligible NDMM patients for ASCT. Patients will be able to get this Darzalex Faspro-containing...
Zydus Lifesciences Ltd stated that the Mexican regulatory authority has approved the marketing of Mamitra, a Trastuzumab biosimilar for treating different cancer types. Mamitra is utilized for treating breast cancer as well as advanced stomach...
Boehringer Ingelheim, a biopharmaceutical company involved in human and animal health, revealed the addition of a new preclinical program through the purchase of Nerio Therapeutics Inc. for a maximum of USD 1.3 billion. Boehringer Ingelheim hopes...
Roche confirmed the finalization of the acquisition of LumiraDx’s Point of Care technology after obtaining all necessary antitrust and regulatory approvals. Roche will now start the complete merging of the company's advanced multi-assay point of...
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