Community-acquired Bacterial Pneumonia
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Sign up freeTop drugs studied for this disease
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FDA label_change · 2025-03-31FDA Approved: NUZYRA — Supplemental Application (Paratek Pharmaceuticals, Inc.)
FDA approved a supplemental application for NUZYRA (omadacycline) to modify the labeling.
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CLINICAL_TRIALS research · 2024-06-14Clinical Trial Update: A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP [Phase 3]
Phase 3b randomized, double-blind study evaluating safety and efficacy of omadacycline versus moxifloxacin for community-acquired bacterial …
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FDA approval · 2023-12-01FDA Approved: BAXDELA — Supplemental Application (Melinta Therapeutics, LLC)
The FDA approved a supplemental application for Baxdela (delafloxacin meglumine) submitted by Melinta Therapeutics, LLC. The update changes …
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CLINICAL_TRIALS trial_result · 2021-12-06Clinical Trial Update: Study of Fluid Collection of the Chest in Children With Pneumonia [Phase 3]
Phase 3 clinical trial investigating fluid collection of the chest in children with pneumonia has completed.
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FDA approval · 2020-10-20FDA Approved: NUZYRA — Supplemental Application (Paratek Pharmaceuticals, Inc.)
FDA approved a supplemental application for NUZYRA (omadacycline) submitted by Paratek Pharmaceuticals, Inc.
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FDA approval · 2020-09-02FDA Approved: NUZYRA — Supplemental Application (Paratek Pharmaceuticals, Inc.)
The FDA approved a supplemental application for NUZYRA (omadacycline) filed by Paratek Pharmaceuticals, Inc.
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FDA approval · 2020-04-09FDA Approved: TIGECYCLINE — Supplemental Application (Sandoz Inc)
FDA approved Sandoz Inc's supplemental application for tigecycline, a generic antibiotic. This action concerns the ANDA for tigecycline (AND…
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CLINICAL_TRIALS trial_result · 2020-02-27Clinical Trial Update: Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia [Phase 3]
Phase 3 trial comparing delafloxacin to moxifloxacin for adults with community-acquired bacterial pneumonia has completed and results were p…
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CLINICAL_TRIALS trial_result · 2019-12-20Clinical Trial Update: Phase II Study of Oral Nafithromycin in CABP [Phase 2]
Phase II study of oral nafithromycin in community-acquired bacterial pneumonia has completed with posted results.
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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 · 2019-06-13FDA 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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FDA approval · 2019-06-11FDA Approved: TIGECYCLINE — Original Application (Eugia US LLC)
FDA approved the original application for a generic tigecycline product by Eugia US LLC, enabling market availability of a generic tigecycli…
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CLINICAL_TRIALS trial_result · 2019-01-03Clinical Trial Update: Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia [Phase 2, Phase 3]
Phase 2/3 clinical trial of solithromycin in adolescents and children with community-acquired bacterial pneumonia has terminated; results po…
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CLINICAL_TRIALS trial_result · 2018-11-29Clinical Trial Update: Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13) [Phase 3]
Phase 3 trial comparing omadacycline to moxifloxacin for community-acquired bacterial pneumonia has completed with results posted in 2018.
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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.)
The FDA granted original approval for Nuzyra (omadacycline) by Paratek Pharmaceuticals for two indications: acute bacterial skin and skin st…
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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 · 2017-03-03Clinical Trial Update: Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia [Phase 3]
A Phase 3 trial comparing oral solithromycin (CEM-101) to oral moxifloxacin for community-acquired bacterial pneumonia has completed, with e…
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CLINICAL_TRIALS trial_result · 2017-03-03Clinical Trial Update: Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia [Phase 3]
Phase 3 efficacy and safety comparison of intravenous-to-oral solithromycin (CEM-101) versus moxifloxacin for community-acquired bacterial p…
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CLINICAL_TRIALS trial_result · 2016-05-30Clinical Trial Update: Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment
Clinical trial evaluating the safety and effectiveness of tigecycline in subjects with complicated skin and skin structure infections and co…
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CLINICAL_TRIALS trial_result · 2016-02-01Clinical Trial Update: Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus [Phase 4]
Phase 4 clinical trial evaluating ceftaroline fosamil versus a comparator in adults with community-acquired bacterial pneumonia at risk for …
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FDA label_change · 2015-08-31FDA Approved: TEFLARO — Supplemental Application (Allergan, Inc.)
FDA entry documenting a supplemental application for TEFLARO (ceftaroline fosamil) submitted by Allergan, Inc. This reflects a labeling or i…
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CLINICAL_TRIALS trial_result · 2014-09-23Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia [Phase 3]
Phase 3 trial comparing intravenous ceftaroline with ceftriaxone in adults hospitalized with community-acquired bacterial pneumonia; complet…
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FDA approval · 2013-05-29FDA Approved: TEFLARO — Supplemental Application (Allergan, Inc.)
The FDA approved a supplemental application for TEFLARO (ceftaroline fosamil) submitted by Allergan, Inc., updating its labeling.