Keeping Track: US FDA Approval Binge Includes Brexafemme, Wegovy, Ryplazim, Truseltiq, Lybalvi, Tembexa

 
• By Bridget Silverman
  
Generate a summary of this article
Listen to this article
Beta

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Keeping Track Feature image

The US Food and Drug Administration is starting off the summer with an array of approvals in historically less-active development areas like women’s health and obesity – along with the ninth novel oncologic of 2021, a new combination antipsychotic product with less of an irksome side effect, a novel smallpox drug intended for the national stockpile, and the first therapy for a rare genetic disorder.

The FDA opened June with approval of Scynexis, Inc.’s Brexafemme (ibrexafungerp), a triterpenoid antifungal for treatment of vulvovaginal candidiasis...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from US FDA Performance Tracker

Ocaliva Confirmatory Trial Failed To Verify Benefit In Primary Biliary Cholangitis, US FDA Says

 
• By Sue Sutter

A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.  

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered. 

EU Filings Tracker TEST

New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.

US FDA Adcomm Reform Ideas: Neutral Facilitator As Chair, Public Hearing Lottery Process Tweaks

 
• By Sue Sutter

Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.

More from Regulatory Trackers

Ocaliva Confirmatory Trial Failed To Verify Benefit In Primary Biliary Cholangitis, US FDA Says

 
• By Sue Sutter

A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.  

Global Pharma Guidance Tracker – August 2024

 
• By Vibha Sharma

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.