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7 FDA Approval Decisions Coming This Quarter

Feb 272 min read

We used our biopharmIQ online platform to identify upcoming FDA approval (PDUFA) dates for biopharma companies through the end of March 2025. See below for more info on these upcoming PDUFA dates (FIG 1).


Check out our free PDUFA calendar for info re: all upcoming PDUFAs in 2025.


These seven drug assets have PDUFA dates before the end of next month:


FUROSCIX (furosemide) - scPharmaceuticals

  • Loop diuretic

  • Indication: Chronic Kidney Disease (CKD)

  • sNDA

  • PDUFA date: March 6, 2025

  • FUROSCIX is an FDA-approved treatment since October 2022 currently indicated for congestion due to fluid overload in adults with New York Heart Association (NYHA) Class II and III chronic heart failure


AMVUTTRA (Vutrisiran) - Alnylam Pharmaceuticals

  • RNAi therapeutic

  • Indication: Transthyretin Amyloidosis with Cardiomyopathy (ATTR-CM)

  • sNDA using Priority Review Voucher

  • PDUFA date: March 23, 2025

  • AMVUTTRA is FDA-approved since June 2022 for the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults. 


TESAMORELIN (F8 Formulation) - Theratechnologies

  • Growth hormone-releasing hormone analog

  • Indication: HIV-Associated Excess Abdominal Fat

  • Resubmitted sBLA 

  • PDUFA date: March 25, 2025

  • Tesamorelin, as EGRIFTA SV® (F4), is FDA-approved since November 2018, for this indication. The sBLA seeks approval for the F8 formulation to succeed it.


GEPOTIDACIN - GSK

  • Triazaacenaphthylene antibiotic

  • Indication: Uncomplicated Urinary Tract Infection (uUTI) 

  • NDA granted Priority Review

  • PDUFA date: March 26, 2025


DCCR (Diazoxide Choline Controlled-Release) - Soleno Therapeutics

  • Extended-release formulation of diazoxide

  • Indication:Prader-Willi syndrome (PWS)

  • Granted Breakthrough, Fast Track, and Orphan Drug Designations

  • NDA granted Priority Review

  • PDUFA date: March 27, 2025 (extended from December 27, 2024)


CARDAMYST (Etripamil) - Milestone Pharmaceuticals

  • Calcium channel blocker (nasal spray)

  • Indication: Paroxysmal Supraventricular Tachycardia (PSVT)

  • NDA

  • PDUFA date: March 27, 2025


  • RNA interference (RNAi) therapy

  • Indication: Hemophilia A or B

  • Granted Breakthrough Therapy Designation

  • NDA

  • PDUFA date: March 28, 2025


Table showing 7 FDA drug approvals by March 2025 with details on drug, indication, therapeutic class, and PDUFA date.

FIG 1. FDA approval decisions remaining in Q1 2025.



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Article History:

Ariel V., Danilo G., Manny V. (Published: 27 February 2025)


Not legal, investing, or tax advice.

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