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Bayer US FDA Accepts Priority Review for Sevabertinib in HER2-Mutant NSCLC
Thursday, May 29, 2025Bayer has announced that the US Food and Drug Administration FDA has accepted its New Drug Application NDA for sevabertinib BAY and granted the investigational treatment Priority Review status
Coherus and STORM Launch Combination Trial of STC-15 and LOQTORZI® in Advanced Solid Tumours
Wednesday, May 28, 2025Coherus BioSciences and STORM Therapeutics have entered into a clinical collaboration to evaluate a new cancer treatment approach The project will test the combination of STC a METTL inhibitor with LOQTORZI toripalimabtpzi a PD inhibitor in patients...
Junshi Biosciences Receives NMPA Approval for Ongericimab’s Supplemental New Drug Applications in China
Wednesday, May 28, 2025Shanghai Junshi Biosciences has announced that the National Medical Products Administration NMPA has approved two supplemental new drug applications sNDAs for its ongericimab injection
Biogen and City Therapeutics Partnership to Develop New RNAi Therapies
Wednesday, May 28, 2025Biogen and City Therapeutics have announced a strategic collaboration to develop selected novel RNAi therapies The partnership will see City Therapeutics apply its advanced RNAi engineering technology to create an RNAi trigger molecule which will be...
Teva’s Anti-IL-15 Candidate for Celiac Disease Receives FDA Fast Track Designation
Wednesday, May 28, 2025Teva Pharmaceutical Industries has announced that the US Food and Drug Administration FDA has granted Fast Track designation to its investigational treatment TEV for celiac disease
Otsuka’s Sibeprenlimab for IgA Nephropathy Granted FDA Priority Review
Tuesday, May 27, 2025Otsuka Pharmaceutical have announced that the US Food and Drug Administration FDA has accepted the Biologics License Application BLA for sibeprenlimab for priority review
Eisai’s DAYVIGO® Receives Approval in China for Adult Insomnia
Tuesday, May 27, 2025Eisai has received regulatory approval in China for its antiinsomnia medicine DAYVIGO lemborexant DAYVIGO is a dual orexin receptor antagonist It blocks orexin signals in the brain which are central to the sleepwake cycle
Abbisko Therapeutics Secures Breakthrough Therapy Designation for Irpagratinib in HCC Treatment
Monday, May 26, 2025Abbisko Therapeutics has received Breakthrough Therapy Designation BTD approval from Chinas Centre for Drug Evaluation CDE part of the National Medical Products Administration NMPA for its novel small molecule FGFR inhibitor irpagratinib ABSK
FDA Approves Genentech’s Susvimo for Diabetic Retinopathy
Friday, May 23, 2025Genentech a member of the Roche Group announced today that the US Food and Drug Administration FDA has approved Susvimo ranibizumab injection mgmL for the treatment of diabetic retinopathy DR a potentially blinding condition that affects almost mil...
Eli Lilly’s Kisunla Receives TGA Approval for Early Alzheimer’s Treatment in Australia
Thursday, May 22, 2025Eli Lilly and Company has received marketing authorisation from the Australian Therapeutic Goods Administration TGA for Kisunla donanemab a treatment for adults with early symptomatic Alzheimers disease Kisunlas Australian approval is also supported...
