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August 09, 2021
FDA has approved the intravenous medication Nexviazyme for treatment of Pompe Disease.
The guidance aids in the development, validation, and use of near infrared-based analytical procedures.
August 05, 2021
EC has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022.
August 04, 2021
The University of Sheffield has launched an innovative gene therapy program that could pave the way for novel treatments for neurodegenerative diseases.
A global safety database analysis has demonstrated no increased incidence of thrombosis with TTS after the second dose of Vaxzevria.
August 03, 2021
FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.
FDA is launching a new crowdsourcing challenge to solicit ideas for pediatric research.
August 02, 2021
The expanded authorization from FDA enables the use of Regeneron Pharmaceuticals’ REGEN-COV antibody cocktail therapy for post-exposure prophylaxis in certain people exposed to SARS-CoV-2.
FDA has approved Mylan Pharmaceuticals’ Semglee, the first interchangeable biosimilar insulin product for treating diabetes.
The agency’s leading cancer expert lashed out at the alarmists and urged continued support for the early access process.