Travere Therapeutics Announces Full FDA Approval of FILSPARI® (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy
September 05, 2024 17:34 ET
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Travere Therapeutics, Inc.
Travere Therapeutics announced that the U.S. FDA has granted full approval to FILSPARI® (sparsentan) to treat IgA nephropathy.
Zevra Therapeutics to Report Second Quarter 2024 Financial Results
July 30, 2024 08:38 ET
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Zevra Therapeutics
CELEBRATION, Fla., July 30, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a rare disease therapeutics company, today announced that it will host a...
Zevra Announces FDA Advisory Committee Meeting to Review Arimoclomol for the Treatment of Niemann-Pick Disease Type C
July 09, 2024 09:00 ET
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Zevra Therapeutics
CELEBRATION, Fla., July 09, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced that the U.S. Food and...
Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea
March 18, 2024 08:30 ET
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Journey Medical Corporation
SCOTTSDALE, Ariz., March 18, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily...
XHANCE Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps
March 15, 2024 15:34 ET
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Optinose, Inc.
ReOpen was the first ever large placebo-controlled clinical trial program to demonstrate statistically significant reduction of symptoms in chronic sinusitis patients without nasal polyps Clinical...
Optinose Announces Reporting Date for Fourth Quarter 2023 Financial Results
February 29, 2024 16:40 ET
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Optinose, Inc.
YARDLEY, Pa., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced...
Optimi Health Congratulates Lykos Therapeutics on FDA Priority Review of New Drug Application And Releases MDMA Production Video
February 12, 2024 07:00 ET
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Optimi Health Corp.
Optimi Health Congratulates Lykos Therapeutics on FDA Priority Review of New Drug Application And Releases MDMA Production Video
Theratechnologies reçoit une mise à jour de la FDA concernant son supplément à la licence de produit biologique pour la formulation F8 de la tésamoréline
January 23, 2024 07:30 ET
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Theratechnologies
La FDA continue d'examiner le dossier après la date butoir du Prescription Drug User Fee Act fixée au 22 janvier 2024 MONTRÉAL, 23 janv. 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc....
Theratechnologies Receives Update from FDA on Tesamorelin F8 Supplemental Biologic License Application
January 23, 2024 07:30 ET
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Theratechnologies
FDA continues to review the file past the Prescription Drug User Fee Act goal date of January 22, 2024 MONTREAL, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the...
Optinose Announces 3-Month Extension of FDA Review Period for the Supplemental New Drug Application for XHANCE
December 06, 2023 07:00 ET
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Optinose, Inc.
The application is based on phase 3 results from the ReOpen clinical trial program showing XHANCE significantly reduced symptoms and sinus opacification in participants with chronic rhinosinusitis ...