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GSK's Granted Blenrep Combination Therapy for Relapsed/Refractory Multiple Myeloma
Monday, December 09, 2024GSK has announced that Chinas National Medical Products Administration NMPA has accepted a new drug application NDA for Blenrep belantamab mafodotin in combination with bortezomib and dexamethasone BVd for the treatment of relapsed or refractory mult...
Cambrex Enters into Partnership with Lilly to Biotech Manufacturing Capabilities
Friday, December 06, 2024Cambrex has announced a new agreement with Eli Lilly and Company to provide expanded support for the clinical development of Lillys biotech collaborators Under this partnership Cambrex will work with Lilly CatalyzeExploRD the companys external innova...
Roche Seeks FDA Approval for Columvi Combo to Treat Relapsed Diffuse Large B-cell Lymphoma
Friday, December 06, 2024Roche has announced that the US Food and Drug Administration FDA has accepted its supplemental Biologics License Application sBLA for Columvi glofitamab in combination with gemcitabine and oxaliplatin GemOx
Mesoblast Secures FDA RMAT Designation for Congenital Heart Disease Treatment
Thursday, December 05, 2024Mesoblast has announced that the US Food and Drug Administration FDA has granted its stromal cell therapy Revascor rexlemestrocelL the Regenerative Medicine Advanced Therapy RMAT designation
Merus Gains FDA Approval for BIZENGRI® (Zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NSCLC
Thursday, December 05, 2024Merus has announced that the United States Food and Drug Administration FDA has granted approval for BIZENGRI zenocutuzumabzbco BIZENGRI is a bispecific antibody targeting HER and HER receptors on cell surfaces including tumour cells It blocks HERHER...
Ono Pharmaceutical Enters into Collaboration with Congruence Therapeutics to Advance Small Molecule Correctors in Oncology
Wednesday, December 04, 2024Ono Pharmaceutical has formed a collaboration with Congruence Therapeutics to develop novel small molecule correctors targeting specific proteins in the field of oncologyThe collaboration will utilise Congruences proprietary Revenir drug discovery pl...
Takeda Enters into License Agreement with Keros Therapeutics to Expand Oncology Pipeline
Wednesday, December 04, 2024Takeda has signed an exclusive licensing agreement with Keros Therapeutics to develop manufacture and commercialise elritercept outside mainland China Hong Kong and Macau Elritercept is a potential bestinclass activin inhibitor targeting activin A an...
Pfizer Receives Approval for 20-valent Pneumococcal Conjugate Vaccine
Wednesday, December 04, 2024Pfizer has received approval from the Hong Kong Department of Health DoH for its valent Pneumococcal Conjugate Vaccine PCV to prevent invasive disease pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants children and adolesc...
Johnson & Johnson Seeks FDA Approval for TREMFYA® to Treat Paediatric Psoriasis and Arthritis
Tuesday, December 03, 2024Johnson Johnson has submitted two supplemental Biologics License Applications sBLAs to the US Food and Drug Administration FDA seeking approval to expand the use of TREMFYA guselkumab for children TREMFYA is a fullyhuman monoclonal antibody that tar...
Cytokinetics Announces FDA Acceptance of Aficamten for Obstructive Hypertrophic Cardiomyopathy
Tuesday, December 03, 2024Cytokinetics has confirmed that the US Food and Drug Administration FDA has accepted its New Drug Application NDA for aficamten Hypertrophic cardiomyopathy HCM is characterised by thickened heart muscle that impairs its ability to pump blood effectiv...
