Catalyst Pharmaceuticals Reports Strong Second Quarter 2023 Financial Results and Provides Corporate Update
August 09, 2023 16:17 ET
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Catalyst Pharmaceuticals, Inc.
Achieved Record Q2 2023 Total Net Revenues of $99.6 MillionAchieved FIRDAPSE® 2023 Second Quarter Net Revenues of $64.9 Million, a 22% Increase YOYAchieved 2023 Second Quarter GAAP EPS Diluted of...
Emergent BioSolutions Receives U.S. FDA Approval of CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, a Two-Dose Anthrax Vaccine for Post-Exposure Prophylaxis Use
July 20, 2023 18:03 ET
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Emergent BioSolutions
Emergent has been delivering CYFENDUS™ vaccine to the U.S. Department of Health and Human Services since 2019, under pre-Emergency Use Authorization status, and will continue to work with the U.S....
Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
May 10, 2023 08:00 ET
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Minerva Neurosciences, Inc
FDA confirms acceptance of the filing of the NDA for roluperidone Application has been granted a standard review FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26,...
FDA Accepts Novan’s NDA for Berdazimer Gel, 10.3% for the Treatment of Molluscum Contagiosum with a PDUFA Goal Date of January 5, 2024
March 07, 2023 08:00 ET
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Novan, Inc.
– FDA completes filing review of application with no filing issues identified – – New Chemical Entity (“NCE”) has potential to be the first FDA-approved prescription product for molluscum in the...
Kiniksa Announces U.S. FDA Acceptance of sBLA and Priority Review for Rilonacept in Recurrent Pericarditis
November 23, 2020 08:00 ET
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Kiniksa Pharmaceuticals, Ltd.
- PDUFA goal date of March 21, 2021 -- Filing based on positive data from RHAPSODY, which achieved its primary and all major secondary endpoints -- Rilonacept BLA for CAPS transferred to Kiniksa from...
RedHill Biopharma Announces FDA Approval of Talicia® for Treatment of H. pylori in Adults
November 04, 2019 06:05 ET
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RedHill Biopharma Ltd.
RedHill plans to launch Talicia®1 in the U.S. in Q1/2020 for the treatment of H. pylori infection in adults, targeting more than two million patients estimated to be treated for H. pylori infection...
US FDA sets PDUFA date for SCENESSE®
January 10, 2019 07:29 ET
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Clinuvel Pharmaceuticals Limited
Executive summary New Drug Application submitted in accordance with section 505(b) of the Federal Food, Drug, and Cosmetic Act, filed in accordance with 21 CFR 314.101(a)Scientific exchange between...
Retrophin Announces U.S. FDA Acceptance of NDA Filing for the New Formulation of Thiola® (tiopronin) in the Treatment of Cystinuria
November 12, 2018 07:00 ET
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Retrophin, Inc.
PDUFA date set for June 30, 2019 SAN DIEGO, Nov. 12, 2018 (GLOBE NEWSWIRE) -- Retrophin, Inc. (NASDAQ: RTRX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review...
Agile Therapeutics Reports Third Quarter 2017 Financial Results
November 06, 2017 16:20 ET
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Agile Therapeutics, Inc.
Cash Expected to Fund Operations into Q2 2018 Prescription Drug User Fee Act (PDUFA) Goal Date for Twirla® is December 26, 2017 PRINCETON, N.J., Nov. 06, 2017 (GLOBE NEWSWIRE) -- Agile...
Neos Therapeutics Receives U.S. FDA Approval of Adzenys ER™ (amphetamine) Extended-Release Oral Suspension for the Treatment of ADHD in Patients 6 Years and Older
September 15, 2017 16:39 ET
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Neos Therapeutics, Inc
DALLAS and FORT WORTH, Texas, Sept. 15, 2017 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (Nasdaq:NEOS), a pharmaceutical company focused on developing, manufacturing and commercializing innovative...