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July 30, 2024 08:38 ET | Source: Zevra Therapeutics

Zevra Therapeutics to Report Second Quarter 2024 Financial Results

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...
July 09, 2024 09:00 ET | Source: Zevra Therapeutics

Zevra Announces FDA Advisory Committee Meeting to Review Arimoclomol for the Treatment of Niemann-Pick Disease Type C

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...
March 18, 2024 08:30 ET | Source: Journey Medical Corporation

Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea

SCOTTSDALE, Ariz., March 18, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily...
March 15, 2024 15:34 ET | Source: Optinose, Inc.

XHANCE Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps

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...
February 29, 2024 16:40 ET | Source: Optinose, Inc.

Optinose Announces Reporting Date for Fourth Quarter 2023 Financial Results

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...
February 12, 2024 07:00 ET | Source: Optimi Health Corp.

Optimi Health Congratulates Lykos Therapeutics on FDA Priority Review of New Drug Application And Releases MDMA Production Video

Optimi Health Congratulates Lykos Therapeutics on FDA Priority Review of New Drug Application And Releases MDMA Production Video
January 23, 2024 07:30 ET | Source: Theratechnologies

Theratechnologies Receives Update from FDA on Tesamorelin F8 Supplemental Biologic License Application

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...
January 23, 2024 07:30 ET | Source: Theratechnologies

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

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....
December 06, 2023 07:00 ET | Source: Optinose, Inc.

Optinose Announces 3-Month Extension of FDA Review Period for the Supplemental New Drug Application for XHANCE

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 ...
December 05, 2023 08:30 ET | Source: Checkpoint Therapeutics, Inc

Checkpoint Therapeutics Strengthens Intellectual Property Protection for Cosibelimab with New U.S. Patent Issuance

Upcoming PDUFA goal date of January 3, 2024 U.S. patent protection for cosibelimab through at least May 2038 WALTHAM, Mass., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc....