FDA
Following a similar decision in case the trade group Outsourcing Facilities Association brought against FDA over its decision to declare the end of the shortage of Novo Nordisk’s semaglutide, Judge Mark Pittman agreed that Eli Lilly’s tirzepatide is in sufficient supply, meaning compounding pharmacies can no longer sell the lucrative weight loss drugs.
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On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s oral cancer drug for a pair of rare tumors.
When it comes to vaccination, the COVID-19 pandemic divided American society. President Donald Trump and his new Health and Human Services secretary are bringing down the hammer. What happens when there is no middle ground?
In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions taken by HHS Secretary Robert F. Kennedy, Jr. and others within the department appear to be at odds with this sentiment.
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Some 20 travel staff at the FDA, who made arrangements for the regulator’s inspectors, will be getting their jobs back, as per the Associated Press. Some food scientists involved in testing will also be reinstated.
With Imaavy, J&J will go toe-to-toe with fellow Big Pharma AstraZeneca, which owns Soliris and Ultomiris.
The FDA has lost several senior employees in recent weeks, including some who have been at the agency for more than two decades.
The condition, recessive dystrophic epidermolysis bullosa, causes chronic wounds and has an 84% mortality rate by age 40.
As tariffs, HHS workforce cuts and the ouster of CBER Director Peter Marks threaten the “lifeblood” of the cell and gene therapy space, experts express wariness over the unknowns and optimism that Marks’ legacy will carry on.
As Marty Makary nears the end of his first month on the job, the FDA Commissioner sat down for two interviews, offering statements that alternatively contradict and jibe with reported events.
Big compounders will have until May 22 to stop producing and dispensing compounded semaglutide, while smaller, state-run pharmacies must immediately stop making copies of the blockbuster drug.
The FDA is asking Novavax for a non-mandatory postmarketing commitment to produce additional clinical data for its investigational COVID-19 vaccine.
The tradipitant saga stretches back to September 2024, when the FDA declined to approve Vanda’s drug in gastroparesis, a stomach condition characterized by delayed gastric emptying.
Novo Nordisk filed for approval of an oral, 25-mg formulation of its weight loss blockbuster “earlier this year,” according to a company spokesperson.