FDA and EMA review Biogen's higher dose SMA drug
CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, ...
Biogen Inc.: FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of SMA CAMBRIDGE, Mass., Jan. 2 ...
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose ...
WebMD22h
FDA Approves New Treatment for Advanced Breast Cancer
The FDA has approved a new treatment for patients with a common form of breast cancer that has spread to other parts of the body or cannot be surgically removed.
Healio23h
FDA approves Spravato as monotherapy for adults with major depressive disorder
The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as ...
BioSpace1d
FDA Presses Pause on Atara’s Programs, Play on Amylyx’s ALS Assets
The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a ...
HealthTech1d
Healthcare Approaches a New Frontier via AI and Quantum Computing
Two clinical research projects have been launched to start the new collaboration. One of the projects, led by Jehi in ...
JD Supra1d
Patent Poetry: Federal Circuit Reverses Novartis Patent Decision
The Federal Circuit has issued a precedential decision reversing a lower court’s decision that certain claims of Novartis’s ...
Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma
The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for ...
Scilex seeks FDA nod for ELYXYB in acute pain management
PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a pharmaceutical company with a current market capitalization of ...
Atara's New Drug Applications Placed on Hold by FDA
Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on its ...
JD Supra2d
Federal Circuit Says Proper Orange Book-Listed Patent Must Claim Active Ingredient
In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon ...