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FDA Approves Genentech’s Vabysmo for the Treatment of Retinal Vein Occlusion (RVO)

Oct 27, 2023
Genentech, a member of the Roche Group announced today that the U.S. Food and Drug Administration (FDA) has approved Vabysmo (faricimab-svoa) for the treatment of macular edema…
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FDA Accepts ImmunityBio’s BLA Resubmission as Complete and Sets New PDUFA Date

Oct 27, 2023
ImmunityBio, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review ImmunityBio’s resubmission of its Biologics License Application (BLA) for N-803, a…
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ViiV Healthcare receives approval from China’s National Medical Products Administration (NMPA) for…

Oct 26, 2023
GSK plc announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders announced that the National Medical Products…
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New data for Arexvy, GSK’s RSV vaccine, show potential to help protect adults aged 50 to 59 at…

Oct 26, 2023
GSK plc announced positive preliminary results from its phase III trial evaluating the immune response and safety of Arexvy (respiratory syncytial virus vaccine, adjuvanted) in adults…
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Servier Announces FDA Approval of TIBSOVO (ivosidenib tablets) for the Treatment of IDH1-Mutated…

Oct 25, 2023
Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, announced the U.S. Food and Drug Administration (FDA) has approved TIBSOVO…
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Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced…

Oct 25, 2023
AstraZeneca and Daiichi Sankyo’s (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with advanced non-small cell…
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Bristol Myers Squibb Announces FDA Breakthrough Therapy Designation for Investigational LPA1…

Oct 25, 2023
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for BMS-986278, a potential first-in-class, oral,…
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LianBio Enters into Agreement with Bristol Myers Squibb for Mavacamten in China and Other Asian…

Oct 24, 2023
LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, announced that the company has entered…
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Astraveus awarded €10.4 million grant by the French government as part of France 2030 investment…

Oct 24, 2023
Astraveus SAS, the creator of modular, microfluidic cell foundries that transform cell and gene therapy (CGT) manufacturing, announces it has been awarded a further €10.4 Million grant…
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Clinical Trial Application (IND) for BioRay Pharmaceutical’s BR105 Injection Receives U.S. FDA…

Oct 24, 2023
BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "BioRay") announced on October 7th that its clinical trial application for BR105 Injection has received approval from the…
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