Food and Drug Administration (FDA)
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Less than 10 days after the FDA slammed Sesen bladder cancer drug with a CRL, the company has withdrawn its Marketing Application Authorization from the European Union.
Merck has announced its vaxneuvance for pneumococcal disease in infants and has met key safety, tolerability, and immunogenicity endpoints in the first 30 days.
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 FDA has approved the use of the injectable drug KORSUVA in treating moderate to severe pruritus in adult patients undergoing hemodialysis for chronic kidney disease.
Many expect the full approval will lead to vaccine mandates, as that was one of the obstacles to it for many organizations.
“You are not a horse. You are not a cow. Seriously, y’all. Stop it.” This is the FDA’s recently tweeted advice to Americans seeking out alternative, unapproved treatments for COVID-19.
Makena injection currently remains on the market but is poised to be removed pending the outcome of the meeting. The final decision will be made in the public hearing.
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.
Fueled by the highly contagious delta variant, life science companies have issued policies on COVID-19 vaccines, including verbiage around exemptions or solutions for medical objections.
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