Regulatory
Tiziana Life Sciences plans to submit an Investigational New Drug Application for a Phase I trial studying intranasal formulab, a breakthrough treatment option for Alzheimer’s Disease.
On Friday, the FDA approved Boostrix, a vaccine administered during the third trimester of pregnancy to prevent pertussis in infants under 2 months of age.
The FDA’s Center for Drug Evaluation and Research issued its briefing documents arguing for the market withdrawal of Covis Pharma’s Makena and will discuss the drug on Oct. 17-19.
The FDA had a fairly quiet week, approving drugs, providing clearance, greenlighting clinical trials, and other regulatory activities for Alnylam, Eli Lilly, Cytokinetics, and more.
Eli Lilly gained ground in the obesity market Thursday as the FDA granted Fast Track designation to Mounjaro (tirzepatide), an investigational drug for adults with obesity.
Provention Bio entered a co-promotion agreement with Sanofi ahead of the possible November approval of teplizumab. If approved, the drug would be the first approved to modify T1D.
The third quarter of 2022 saw continued job cuts, a shift in focus away from COVID-19, an unexpected boost in the Alzheimer’s research space and increased scrutiny of accelerated approvals.
The FDA’s approval of Amylyx’s Relyvrio has ignited the growing momentum in the ALS space. BioSpace spoke with Amylyx co-CEOs Justin Klee and Josh Cohen and leading ALS researcher Dr. Merit Cudkowicz.
Theratechnologies’ Trogarzo for HIV, Alnylam’s Lumasiran for advanced primary hyperoxaluria, scPharmaceuticals’ Furoscix for heart failure and more. Here’s a look at the FDA’s October calendar.
The FDA had a busy week, approving drugs, greenlighting clinical trials and other regulatory activities for Immuneering, Amylyx, Sarepta, Sanofi, and Regeneron and more.
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