Category News

Mevion Medical

Mevion Medical Systems Receives CE Mark for World’s First LINAC Vault-Ready Proton Therapy System

Regulatory Milestone Enables European Expansion of Advanced Proton Therapy Why is proton therapy still out of reach for many European cancer centers? Mevion Medical Systems, the global leader in compact proton therapy, has announced that the MEVION S250-FIT Proton Therapy…

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Savara

Savara Reports FDA Filing of BLA for MOLBREEVI in Autoimmune Pulmonary Alveolar Proteinosis

Savara Announces the U.S. Food and Drug Administration (FDA) Filed the MOLBREEVI* Biologics License Application (BLA) in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Savara Inc. a clinical-stage biopharmaceutical company focused on rare respiratory diseases, announced the FDA has filed for…

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Dr. Reddy’s

Dr. Reddy’s Secures FDA Review of Biologics License Application for Abatacept Biosimilar

Dr. Reddy’s Announces USFDA Acceptance to Review Its Biologics License Application (BLA) for Proposed Interchangeable Biosimilar, Abatacept Dr. Reddy’s Laboratories Ltd. along with its subsidiaries together referred to as “Dr. Reddy’s”), today announced that the US Food and Drug Administration…

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FDA

FDA Accepts Genentech’s NDA for Giredestrant in ESR1-Mutated Advanced Breast Cancer

FDA Accepts New Drug Application for Genentech’s Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer Genentech, a member of the Roche Group announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application for giredestrant,…

Read MoreFDA Accepts Genentech’s NDA for Giredestrant in ESR1-Mutated Advanced Breast Cancer