Regulatory
Mindset Pharma was granted allowance by the U.S. Patent and Trademark Office for its application for a psilocybin-based family of drugs to treat central nervous system disorders.
Emory University’s Ken Thorpe told BioSpace that the average Medicaid spending on drugs approved under the accelerated pathway in relation to total Medicaid spending is.2%.
A cancer drug co-developed by Coherus BioSciences and Junshi Biosciences, toripalimab, is getting another opportunity before the U.S. Food and Drug Administration.
As the calendar pages continue to turn, the FDA has a slew of novel drugs awaiting approval, several of which are likely to become game-changers for patients and key assets for companies.
The FDA lifted the clinical hold on Dyne Therapeutics’ clinical study of DYNE-251 in Duchenne muscular dystrophy (DMD) patients amenable to skipping exon 51. A Phase I/II trial is expected by mid-year.
Following the Supreme Court’s decision to overturn Roe v. Wade, abortion rights activists are calling for the FDA to consider making abortion medication Mifeprex an over-the-counter option for patients.
The FDA lifted its clinical hold on Vertex Pharmaceuticals’ Phase I/II clinical trial of VX-880, a pancreatic islet cell replacement therapy for people with Type I Diabetes (TID).
Provention Bio announced the FDA extended its review period by three months for the Biologics License Application (BLA) of its diabetes prevention drug, teplizumab to Nov. 17.
Citing an unnamed FDA insider, the regulator is in the process of devising a plan to enable clinical testing on a larger scale.
Companies are still developing and refining treatments and preventions for COVID-19, but not all of them are approved or authorized. Here’s a look at the latest COVID-19 news.
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