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Tagrisso approved in the US for patients with unresectable, Stage III EGFR-mutated lung cancer

Sep 27, 2024
AstraZeneca’s Tagrisso (osimertinib)​ has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm)…
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Pfizer Voluntarily Withdraws All Lots of Sickle Cell Disease Treatment OXBRYTA (voxelotor) From…

Sep 26, 2024
Pfizer Inc. announced that it is voluntarily withdrawing all lots of OXBRYTA (voxelotor) for the treatment of sickle cell disease (SCD) at this time, in all markets where it is…
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AskBio to collaborate with Belief BioMed to explore the potential of new gene therapies

Sep 26, 2024
Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, announced a new strategic…
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Lilly’s Kisunla (donanemab-azbt) Approved in Japan for the Treatment of Early Symptomatic…

Sep 25, 2024
The Ministry of Health, Labour and Welfare Japan has approved Kisunla (donanemab-azbt, 350 mg/20 mL every four weeks injection for IV infusion), Eli Lilly and Company's Alzheimer's…
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FDA Declines to Approve Vanda’s Marketing Application for Tradipitant in Gastroparesis

Sep 20, 2024
Vanda Pharmaceuticals Inc. (Vanda) provided an update on its tradipitant development program. On September 18, 2024, the U.S. Food and Drug Administration (FDA) declined to approve…
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Papillon Therapeutics Secures Orphan Drug Designation from FDA for PPL-001 in Friedreich’s…

Sep 19, 2024
Papillon Therapeutics Inc., a clinical-stage biotechnology company advancing a pipeline of multi-systemic genetic medicines directed at the underlying causes of inherited disease,…
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FDA Approves Merck’s KEYTRUDA (pembrolizumab) Plus Pemetrexed and Platinum Chemotherapy as…

Sep 19, 2024
Merck, known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination…
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BeiGene Receives Israeli Ministry of Health Approval for TEVIMBRA for the Treatment of Oesophageal…

Sep 19, 2024
BeiGene, Ltd. announced that the Israeli Ministry of Health (IL MOH) has approved TEVIMBRA (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or…
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Cell Therapy Analytical and Quality Control Experts to Gather in Boston this December for the 6th…

Sep 19, 2024
Prepare for the definitive meeting dedicated to refining analytics to ensure the swift progression of highly efficacious products through IND and clinical trials, ultimately securing…
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Valneva Submits Label Extension Applications for its Chikungunya Vaccine, IXCHIQ, to EMA and Health…

Sep 18, 2024
Valneva SE, a specialty vaccine company, announced that it has submitted label extension applications to the European Medicines Agency (EMA) and Health Canada to potentially expand the…
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