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October 04, 2021
Vaccine access campaigners have projected a request to waive vaccine patents onto the hotel where the annual conservative party conference is being held.
October 02, 2021
A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.
October 01, 2021
FDA and EMA are looking to tap real-world data and real-world evidence more broadly to accelerate the research and market approval process.
EMA's CHMP is going to perform an accelerated assessment of data submitted by Moderna regarding the use of a booster dose of Spikevax.
EMA is providing support via its Innovation Task Force (ITF) for developers to help them reduce, replace, and refine animal use in drug development.
September 30, 2021
FDA granted orphan drug designation to Catalyst Biosciences’ MarzAA for the treatment of Factor VII Deficiency.
FDA approved AbbVie’s Qulipta (atogepant) as a preventative migraine treatment.
September 29, 2021
GeneTx Biotherapeutics and Ultragenyx Pharmaceutical announced that FDA has removed the clinical hold on GTX-102, an investigational treatment for Angelman syndrome.
September 27, 2021
The lack of a new permanent commissioner has hampered FDA in articulating future priorities and pushing back against miscommunications and outside complaints.
Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.