The Food and Drug Administration’s decision next week whether to approve the first treatment for Alzheimer’s disease highlights a deep division over the drug’s benefits as well as criticism about
FDA Approves New Drug for Yeast Infection
June 3, 2021 The FDA has approved a new drug for vaginal yeast infections, something 3 out of every 4 women encounter at least once in their life.
Ibrexafungerp is the first drug approved in a new antifungal class for the condition, in more than 20 years, the drug s manufacturer Scynexis said in a press release. It is the first drug that does not use a type of antifungal known as azoles to treat vaginal yeast infections.
The company said approval came after positive results from two phase III studies in which an oral version of the drug showed efficacy and tolerability. The most common reactions observed in clinical trials were diarrhea, nausea, abdominal pain, dizziness, and vomiting.
FDA Reviewers: Why We Are Against Approval of Aducanumab medscape.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medscape.com Daily Mail and Mail on Sunday newspapers.
Pfizer Prepares to File for Full FDA Approval of its Covid Vaccine Posted on 2647
Pfizer (NYSE: PFE) is set to file for full U.S. FDA approval of its Covid1-9 vaccine by the end of the month. If the FDA were to authorize the request, the company would be eligible to market directly to consumers. Shares rose 1.3% during premarket trading.
The three vaccines currently on the market only have an Emergency Use Authorization (EUA), which means that though they are “authorized” by the FDA, they have not been “approved.” In order to receive full approval, also known as a Biologics License, companies must submit six months worth of data.