Etripamil

The FDA in 2025 is set to approve its lowest number of new drug and biologic applications since 2022, even as more than a dozen companies await the regulator’s decisions on their new molecular entities before the end of the year. The number of drug approvals isn’t always indicative of the quality of innovation or whether major strides are being made in hard-to-treat diseases. But it does provide an indication of R&D performance year-over-year. It’s also unclear whether losing thousands of FDA staff played a role in slowing down the approval process this year. The FDA has approved 42 new drugs and biologics so far this year, with about 16 decisions to go before 2026, according to an Endpoints News tally . In comparison, the regulator approved 69 new drugs and biologics in 2024, and 80 in 2023. But it was 2022 that had the fewest number of new approvals since 2020, with 51 new drugs and biologics approved. In 2020, the FDA approved 61 new drugs and biologics, and 63 in 2021. An FDA spokesperson told Endpoints News that “drug reviews and approvals are not affected by the Democrat-led shutdown and this work continues.” This year’s approval numbers likely won’t hit historic highs if applications continue to be delayed at the same rate as they have been recently . Back in July, FDA Commissioner Marty Makary told CNBC that the agency “could hit a record number of approvals” in 2025. The FDA spokesperson did not comment on whether that prediction still stands. Hello, Craig Smith! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Craig Smith! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Craig Smith! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Craig Smith! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Craig Smith! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Craig Smith! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Craig Smith! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Craig Smith. You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. At least 18 companies are still waiting for the FDA to decide whether to approve their new drug or biologic applications this year:

MONTREAL and CHARLOTTE, N.C., Oct. 09, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it will present a poster presentation at the American Heart Association Scientific Sessions 2025, to be held November 7-10th in New Orleans, Louisiana. Data to be presented describe the efficacy, safety, and tolerability of self-administered etripamil by patients with episodes of paroxysmal supraventricular tachycardia. AHA 2025 Presentation Details: Poster Presentation Title: Combined Efficacy, Safety, and Test Dose Tolerability of Etripamil for Acute Paroxysmal Supraventricular Tachycardia (PSVT) Across Multiple Clinical Trials Presenter: James Ip, M.D., Associate Professor and Director of Cardiac Pacing and Implantable Devices, Division of Cardiology, Weill Cornell Medicine, New York Presbyterian Hospital Date and time: Monday, November 10, 2025, 10:30 – 11:30 AM CST About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for etripamil for treatment of an abnormal heart rhythm, paroxysmal supraventricular tachycardia or PSVT. Investor Relations Kevin Gardner, kgardner@lifesciadvisors.com Source: Milestone Pharmaceuticals Inc.