Regulatory
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.
There’s quite a bit of movement on the Omicron-specific booster shot and updated supply deals, despite world leaders shifting their attention away from the COVID-19 pandemic.
The FDA’s decision came after researchers found cases of drug-induced liver injury in some patients. Tolebrutinib is being evaluated for relapsing types of MS, MG, nrSPMS, and PPMS.
Spero Therapeutics received a Complete Response Letter from the U.S. Food and Drug Administration for its complicated urinary tract infection therapy, tebipenem HBr oral tablets.
Monday morning, Nuvation Bio announced that the U.S. Food and Drug Administration placed a partial clinical hold on its Phase I dose escalation study of NUV-422.
The FDA has placed Astellas Pharma’s Phase I/II FORTIS trial on clinical hold after one of its study participants experienced a serious adverse event.
Talks between Merck and Seagen are heating up as the former looks to buy the latter, according to a report published by The Wall Street Journal.
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