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Aridis’ AR-301 Monoclonal Antibody is Among the First Biologics to Receive FDA’s Qualified Infectious Diseases Product (QIDP) Designation
July 12, 2023 08:00 ET | Aridis Pharmaceuticals, Inc.
QIDP designation for Biologics provides FDA Priority Review status LOS GATOS, Calif., July 12, 2023 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company...
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RedHill Biopharma Announces FDA Orphan Drug Designation for RHB-204 for the Treatment of NTM Infections
October 14, 2020 11:00 ET | RedHill Biopharma Ltd.
RHB-204 Phase 3 study in pulmonary NTM infections is planned to be initiated in the coming weeks--Orphan Drug Designation, along with RHB-204’s FDA QIDP priority designation, will extend U.S....
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FDA Grants Qualified Infectious Disease Product Designation to Taksta(TM) Cempra's Fusidic Acid Antibiotic
September 18, 2015 07:00 ET | Melinta Therapeutics, Inc.
CHAPEL HILL, N.C., Sept. 18, 2015 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the...
Melinta Therapeutics
Melinta Therapeutics Demonstrate Delafloxacin's Potent and Rapid Antimicrobial Activity against Neisseria Gonorrhoeae
September 08, 2014 11:01 ET | Melinta Therapeutics
NEW HAVEN, Conn, Sept. 8, 2014 (GLOBE NEWSWIRE) -- Melinta Therapeutics today announced results from in vitro studies that highlight the potential of delafloxacin, an investigational fluoroquinolone,...
Melinta Therapeutics
Melinta Therapeutics Highlighting Delafloxacin and ESKAPE Candidates in Twelve Presentations at 2014 ICAAC Meeting
September 04, 2014 10:45 ET | Melinta Therapeutics
NEW HAVEN, Conn, Sept. 4, 2014 (GLOBE NEWSWIRE) -- Melinta Therapeutics today announced that an additional three abstracts have been accepted as late-breakers at the annual Interscience Conference...
Melinta Therapeutics
Melinta Therapeutics Reports Top-Line Results Showing Equivalent Exposures after Oral and Intravenous Delafloxacin Administration
August 11, 2014 12:00 ET | Melinta Therapeutics
NEW HAVEN, Conn, Aug. 11, 2014 (GLOBE NEWSWIRE) -- Melinta Therapeutics today announced top-line results of a Phase 1 clinical study that demonstrated that the administration of single doses of...
Melinta Therapeutics
Melinta Therapeutics' Phase 3 Study of I.V. and Oral Delafloxacin has Begun Enrolling Patients with Acute Bacterial Skin and Skin Structure Infections
May 05, 2014 11:27 ET | Melinta Therapeutics
NEW HAVEN, Conn, May 5, 2014 (GLOBE NEWSWIRE) -- Melinta Therapeutics today announced that patient enrollment has commenced in a Phase 3 trial of oral and intravenous (I.V.) delafloxacin, a...
Melinta Therapeutics
Melinta Therapeutics to Present at Needham & Company's Annual Healthcare Conference
April 03, 2014 14:38 ET | Melinta Therapeutics
NEW HAVEN, Conn, April 3, 2014 (GLOBE NEWSWIRE) --  Melinta Therapeutics today announced that Mary Szela, the Company's chief executive officer, will be presenting a corporate update at Needham...
Melinta Therapeutics
Melinta Therapeutics Raises $70 Million to Support Delafloxacin NDA and Selection of Multi-Drug Resistant Gram-Negative Candidates from RX-04 Platform
February 10, 2014 07:30 ET | Melinta Therapeutics
NEW HAVEN, Conn, Feb. 10, 2014 (GLOBE NEWSWIRE) -- Melinta Therapeutics today announced the closing of a $70 Million Series 3 equity financing.  Current investor, Vatera Healthcare Partners,...
Melinta Therapeutics
Melinta Therapeutics Initiates Phase 3 Registration Study of Delafloxacin in Individuals with Uncomplicated Gonorrhea
January 09, 2014 08:00 ET | Melinta Therapeutics
NEW HAVEN, Conn, Jan. 9, 2014 (GLOBE NEWSWIRE) --  Melinta Therapeutics today announced the initiation of a Phase 3 trial of delafloxacin, a novel investigational fluoroquinolone, for the...