Regulatory
Reuters alleges Johnson & Johnson knew of the ketoacidosis risk of its diabetes drug Invokana but covered it up.
Shares of Reata Pharmaceuticals have plunged nearly 40% in premarket trading after an FDA advisory panel recommended against the approval of its Alport syndrome disease treatment, bardoxolone.
In the staff documents, the FDA scientists expressed concerns over the Reata clinical data that was submitted.
The U.S. Food and Drug Administration is wrapping up 2021 with a fairly busy schedule for the month of December. Here’s a look at the first half of the month.
In the CRL, the FDA indicated that the single registrational trial (106 Phase III) did not provide sufficient proof of efficacy to demonstrate benefit.
The FDA’s Antimicrobial Drugs Advisory Committee voted 13 to 10 to recommend emergency authorization of molnupiravir. Read more about the authorization here.
Sigilon Therapeutics announced it may have discovered the reason why its experimental cell therapy treatment for severe hemophilia A was placed on clinical hold by the FDA.
Shares of Kura Oncology have plunged nearly 30% in premarket trading after the FDA placed a partial clinical hold on the company’s Phase Ib leukemia study following the report of a patient’s death.
The FDA approved Takeda’s Livtencity (maribavir) for adults and children 12 years or older with post-transplant cytomegalovirus (CMV) infection.
Tonix expects to begin enrollment in the trial for TNX-1900, an intranasal potentiated oxytocin, during the second half of 2022.
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