Current:Home > ScamsFDA declines to approve nasal spray alternative to EpiPen, company says-Angel Dreamer Wealth Society D1 Reviews & Insights
FDA declines to approve nasal spray alternative to EpiPen, company says
View Date:2024-12-23 19:50:42
Regulators at the U.S. Food and Drug Administration declined to approve a needle-free nasal spray equivalent to an EpiPen, pending further study, according to the company developing it.
ARS Pharma developed the product, Neffy, which is inhaled and would have been available by prescription if approved.
Neffy would be a first-of-its-kind alternative to an EpiPen, which is commonly used to treat anaphylaxis, or severe allegoric reactions.
The FDA said they haven't yet seen enough evidence to support approval. The company will have an opportunity to run additional studies and apply for approval again.
'We are very surprised by this action and the late requirement at this time to change the repeat-dose study from a post-marketing requirement, which we had previously aligned on with FDA, to a pre-approval requirement, particularly given the positive Advisory Committee vote," Richard Lowenthal, CEO of ARS, said in a statement on Tuesday.
ARS shares fell sharply, dropping about 58% in pre-market trade on Wednesday morning.
This is a developing story. Please check back for updates.
veryGood! (7)
Related
- Caitlin Clark has one goal for her LPGA pro-am debut: Don't hit anyone with a golf ball
- Could the U.S. still see a recession? A handy primer about the confusing economy
- Kevin Costner Ordered in Divorce Docs to Pay Estranged Wife Christine $129K Per Month in Child Support
- A Gary, Indiana Plant Would Make Jet Fuel From Trash and Plastic. Residents Are Pushing Back
- Ben Foster files to divorce Laura Prepon after 6 years, according to reports
- Blockbuster drug Humira finally faces lower-cost rivals
- The TikTok-Famous Zombie Face Delivers 8 Skincare Treatments at Once and It’s 45% Off for Prime Day
- Biden Administration’s Global Plastics Plan Dubbed ‘Low Ambition’ and ‘Underwhelming’
- Princess Kate makes rare public appearance after completing cancer chemo
- In-N-Out Burger bans employees in 5 states from wearing masks
Ranking
- Gold is suddenly not so glittery after Trump’s White House victory
- Proof Emily Blunt and Matt Damon's Kids Have the Most Precious Friendship
- Up First briefing: Climate-conscious buildings; Texas abortion bans; GMO mosquitoes
- Al Gore Talks Climate Progress, Setbacks and the First Rule of Holes: Stop Digging
- The state that cleared the way for sports gambling now may ban ‘prop’ bets on college athletes
- Planet Money Paper Club
- In Court, the Maryland Public Service Commission Quotes Climate Deniers and Claims There’s No Such Thing as ‘Clean’ Energy
- An experimental Alzheimer's drug outperforms one just approved by the FDA
Recommendation
-
Jelly Roll goes to jail (for the best reason) ahead of Indianapolis concert
-
Herbal supplement kratom targeted by lawsuits after a string of deaths
-
Twitter replaces its bird logo with an X as part of Elon Musk's plan for a super app
-
Finally, a Climate Change Silver Lining: More Rainbows
-
College football Week 12 expert picks for every Top 25 game include SEC showdowns
-
Four Big Things to Expect in Clean Energy in 2023
-
An ultra-processed diet made this doctor sick. Now he's studying why
-
In the End, Solar Power Opponents Prevail in Williamsport, Ohio