Bacterial Skin and Skin Structure Infections
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2020-04-10Clinical Trial Update: Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) [Phase 4]
Phase 4 clinical trial evaluating a new pathway for treating acute bacterial skin and skin structure infections has completed with results p…
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FDA approval · 2019-12-11FDA Approved: ORBACTIV — Supplemental Application (Melinta Therapeutics, LLC)
FDA approved a supplemental application for ORBACTIV (oritavancin) filed by Melinta Therapeutics, LLC.
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FDA approval · 2019-10-24FDA Approved: BAXDELA — Supplemental Application (Melinta Therapeutics, LLC)
The FDA approved a supplemental application for Baxdela (delafloxacin meglumine) submitted by Melinta Therapeutics.
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FDA approval · 2019-09-09FDA Approved: SIVEXTRO — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approved a supplemental application for Sivextro (tedizolid phosphate) from Merck Sharp & Dohme LLC.
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FDA approval · 2019-06-13FDA Approved: NUZYRA — Supplemental Application (Paratek Pharmaceuticals, Inc.)
FDA approves a supplemental application for NUZYRA (omadacycline) submitted by Paratek Pharmaceuticals, Inc. The approval pertains to a supp…
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FDA label_change · 2019-06-13FDA Approved: NUZYRA — Supplemental Application (Paratek Pharmaceuticals, Inc.)
FDA notice about a supplemental application for Nuzyra (omadacycline) from Paratek Pharmaceuticals to request changes to the product label; …
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CLINICAL_TRIALS trial_result · 2019-04-19Clinical Trial Update: Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections [Phase 3]
Phase 3 trial comparing oral sodium fusidate (CEM-102) to oral linezolid for acute bacterial skin and skin structure infections has complete…
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FDA label_change · 2019-03-06FDA Approved: SIVEXTRO — Supplemental Application (Merck Sharp & Dohme LLC)
The FDA approved a supplemental application for SIVEXTRO (tedizolid phosphate) submitted by Merck, resulting in labeling changes for the pro…
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FDA approval · 2018-10-18FDA Approved: BAXDELA — Supplemental Application (Melinta Therapeutics, LLC)
FDA approves a supplemental application for Baxdela (delafloxacin meglumine) submitted by Melinta Therapeutics, LLC.
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FDA approval · 2018-10-02FDA Approved: NUZYRA — Original Application (Paratek Pharmaceuticals, Inc.)
FDA approved NUZYRA (omadacycline) from Paratek Pharmaceuticals as an original application. The approval covers acute bacterial skin and ski…
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FDA approval · 2018-10-02FDA Approved: NUZYRA — Original Application (Paratek Pharmaceuticals, Inc.)
The FDA granted original approval for Nuzyra (omadacycline) by Paratek Pharmaceuticals for two indications: acute bacterial skin and skin st…
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CLINICAL_TRIALS trial_result · 2018-08-14Clinical Trial Update: Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections [Phase 3]
Phase 3 trial comparing single-dose versus two-dose dalbavancin regimens for acute bacterial skin and skin structure infections completed wi…
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FDA approval · 2018-07-24FDA Approved: DALVANCE — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for dalbavancin (DALVANCE) from Allergan, resulting in updated labeling for its approved indications…
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CLINICAL_TRIALS trial_result · 2018-07-11Clinical Trial Update: Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2 [Phase 3]
Phase 3 study REVIVE-2 comparing iclaprim to vancomycin for acute bacterial skin and skin structure infections has completed with results po…
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CLINICAL_TRIALS trial_result · 2018-06-19Clinical Trial Update: Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1 [Phase 3]
A Phase 3 trial (REVIVE-1) comparing iclaprim to vancomycin for acute bacterial skin and skin structure infections has completed with result…
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FDA approval · 2018-03-20FDA Approved: ORBACTIV — Supplemental Application (Melinta Therapeutics, LLC)
FDA approved a supplemental application for ORBACTIV (oritavancin) submitted by Melinta Therapeutics, LLC.
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CLINICAL_TRIALS trial_result · 2017-08-28Clinical Trial Update: Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections [Phase 3]
Phase 3 trial results compare delafloxacin with standard therapy (vancomycin plus aztreonam) for acute bacterial skin and skin structure inf…
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CLINICAL_TRIALS trial_result · 2017-08-24Clinical Trial Update: Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections [Phase 3]
Phase 3 trial comparing delafloxacin to vancomycin plus aztreonam for acute bacterial skin and skin structure infections has completed with …
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FDA approval · 2017-06-19FDA Approved: BAXDELA — Original Application (Melinta Therapeutics, LLC)
FDA approved Baxdela (delafloxacin meglumine) from Melinta Therapeutics. The approval covers the original New Drug Application NDA208610 for…
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FDA approval · 2017-06-19FDA Approved: BAXDELA — Original Application (Melinta Therapeutics, LLC)
The FDA approves Baxdela (delafloxacin meglumine) for the treatment of acute bacterial skin and skin structure infections, with an additiona…
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CLINICAL_TRIALS trial_result · 2016-11-01Clinical Trial Update: Clinical and Economic Outcomes of Ceftaroline Fosamil for ABSSSI Documented or at Risk of MRSA [Phase 4]
Phase 4 study evaluating the clinical and economic outcomes of ceftaroline fosamil for acute bacterial skin and skin structure infections as…
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FDA approval · 2016-10-17FDA Approved: ORBACTIV — Supplemental Application (Melinta Therapeutics, LLC)
The FDA approved a supplemental application for ORBACTIV (oritavancin) from Melinta Therapeutics, LLC.
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FDA approval · 2016-09-16FDA Approved: SIVEXTRO — Supplemental Application (Merck Sharp & Dohme LLC)
The FDA approved a supplemental application for SIVEXTRO (tedizolid phosphate) submitted by Merck Sharp & Dohme LLC.
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FDA approval · 2016-01-20FDA Approved: ORBACTIV — Supplemental Application (Melinta Therapeutics, LLC)
The FDA approved a supplemental application for ORBACTIV (oritavancin) submitted by Melinta Therapeutics, LLC. The action concerns the appro…
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FDA approval · 2015-12-18FDA Approved: DALVANCE — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for DALVANCE (dalbavancin) from Allergan, Inc.