Regulatory
Henceforth, all JAK-inhibiting drugs like AbbVie’s Rinvoq, Pfizer’s Xeljanz, and Lilly’s Olumiant, have been ordered to include a warning label on the medicine to be sold in the U.S.
Marion Gruber, director of the agency’s Office of Vaccines Research & Review is leaving at the end of October. Phil Krause, OVRR’s deputy director, is exiting in November.
The CDC is taking a proactive stance and establishing a center that will use forecasting and outbreak analytics to guide public health decision-making.
The petition was posted on Monday by shareholder rights law firm Labaton Sucharow.
Shares of Tonix Pharmaceuticals were up nearly 11% in premarket trading after the company announced plans to initiate a Phase II study of TNX-102 SL as a potential treatment for Long COVID Syndrome following a positive meeting with the U.S. FDA.
The new authorization is expected to be the final reassurance for many of those who had hesitated when the vaccine was approved under emergency use only.
Many expect the full approval will lead to vaccine mandates, as that was one of the obstacles to it for many organizations.
The U.S. FDA has a busy schedule for the end of August and beginning of September. Let’s take a look.
Woodcock faces heavy opposition from an evenly divided U.S. Senate, particularly from West Virginia Sen. Joe Manchin, who has been critical of the approval process for Biogen’s Aduhelm, formerly known as aducanumab.
The decision is largely based on three studies.
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