The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of adult and pediatric patients aged 12 years and ...
Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department ...
The executive order, which Biden signed in October 2022, had not spurred any lower drug prices by the time Trump revoked it Jan. 20. The order directed the Health and Human Services Department ...
Trump rescinded Executive Order 14087, "Lowering Prescription Drug Costs for Americans," which directed Medicare and Medicaid ...
In 2025, more than 3 million seniors are going to save thousands of dollars because of a new spending limit on prescription drugs. It's unclear whether the Trump Administration will keep the law.
Viral social media posts claim that one of the orders revoked was one that lowered prescription drug costs for people ...
The NDA, which was completed in October 2024, has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of June 30, 2025. In addition, the FDA has stated that it ...
A Prescription Drug User Fee Act (PDUFA) action date is August 31, 2025. The BLA is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modeling of observed data.
Setting a Prescription Drug User Fee Act action deadline of June 30, 2025, the FDA granted Priority Review, Verastem stated in a statement. Warning! GuruFocus has detected 5 Warning Signs with VSTM.
Trump's executive order does not change portions of Biden's Inflation Reduction Act that created a $2,000 out-of-pocket cap on prescription drugs, placed a $35 cap on Insulin, and allowed HHS to ...
and substance use disorder, CMS said. Since April 1, 2023, people with Medicare have seen savings on over 120 drugs thanks to Inflation Reduction Act’s Medicare Prescription Drug Inflation ...