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Pipeline
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Akcea Therapeutics | TEGSEDITM (inotersen) | Polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults | Granted approval by the FDA |
Akcea Therapeutics | AKCEA-APO(a)-LRx | Cardiovascular disease (CVD) and elevated levels of lipoprotein(a), or Lp(a) | Positive topline results from a Phase II clinical trial |
Bausch Health Companies, Inc. | BRYHALI™ (halobetasol propionate) Lotion, 0.01% | Plaque psoriasis in adults | FDA tentatively approved New Drug Application; final OK pending expiration of exclusivity for related product |
Eximo Medical Ltd | B-Laser™ Atherectomy System | Peripheral artery disease (PAD) | Granted 510(k) clearance by the FDA |
YiSheng BioPharma Co. | PIKA® rabies vaccine | Rabies | Granted clearance by the China FDA to proceed with a clinical trial |
Genentech | Hemlibra | Hemophilia A patients without factor VIII inhibitors | Granted approval by the FDA |
Leadiant Biosciences, Inc. | Revcovi™ (elapegademase-lvlr) injection | Adenosine deaminase severe combined immune deficiency (ADA-SCID) in children and adults | Granted approval by the FDA |
Breckenridge Pharmaceutical, Inc. | Roflumilast Tablets, 500mcg (generic for Daliresp® Tablets) | COPD | Abbreviated New Drug Application approved by the FDA |
Valneva USA | XIARO® (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) | Japanese encephalitis | Accelerated dosing regimen approved by the FDA |
Eidos Therapeutics, Inc. | AG10 | amyloidosis (ATTR) | Granted Orphan Drug designation by the FDA |
Paratek Pharmaceuticals, Inc. | NUZYRA™ (omadacycline) | Community-acquired bacterial pneumonia; acute skin infections (ABSSSI) in adults | Granted approval by the FDA |
Poxel SA | Imeglimin, an investigational therapeutic agent | Type 2 diabetes | Patient enrollment completed in the TIMES 2 trial of the Phase III registration program |
Chugai Pharmaceutical Co., Ltd | HEMLIBRA® (US generic name: emicizumab-kxwh) | Hemophilia A without factor VIII inhibitors in newborns, children and adults | Granted approval by the FDA |
Genentech | baloxavir marboxil | Influenza type A/H3N2 and type B | Phase III CAPSTONE-2 trial showed symptoms improved significantly faster in patients at high risk of serious flu who took the drug v. a placebo |
Zealand Pharma A/S | Glepaglutide | Short bowel syndrome (SBS) | First patient enrolled in a global Phase III trial |
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