Melinta Therapeutics’ Antibiotic Approved by FDA for Serious Skin Infections
The U.S. Food and Drug Administration (FDA) approved of Melinta Therapeutics' antibiotic Kimyrsa (oritavancin) for adults diagnosed with acute bacterial skin and skin structure infections (ABSSSI). Caused by susceptible isolates of designated Gram-positive...
PTC Announces Results of Real-World Study
PTC Therapeutics announced today the results of its real-world study for patients diagnosed with Becker muscular dystrophy (BMD) and Duchenne muscular dystrophy (DMD) who switched between prednisone to EMFLAZA® (deflazacort) after the U.S. Food and Drug...
FDA Grants Orphan Drug Designation to Alkermes for Treatment of Mucosal Melanoma
Alkermes today (3/11) announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for its nemvaleukin alfa, an investigational engineered interleukin-2 (IL-2) variant immunotherapy for treatment of mucosal melanoma, a rare type of...
FDA Clears Valkyrie Thoracic Fixation System
The U.S. Food and Drug Administration (FDA) cleared Able Medical Devices' thoracic fixation system called Valkyrie, a breakthrough and fully disposable bioactive sternal plating system. The medical device is intended to stabilize and fixate chest wall fractures as...
FDA Provides Guidance on Switches to Container Closure
The U.S. Food and Drug Administration (FDA) provided guidance that addresses changes to the supply chain due to COVID-19, including its regulatory process for manufacturing and controls (CMS) and chemistry. Materials like glass vials, stoppers, test swabs, and...
FDA Grants Fourth Breakthrough Device Designation for MedAlliance’s Sirolimus Drug-Eluting Balloon
The U.S. Food and Drug Administration (FDA) granted MedAlliance its fourth Breakthrough Device Designation for SELUTION SLR™, a sustained limus release drug-eluting balloon (DEB) catheter, to treat atherosclerotic lesions found in native coronary arteries. MedAlliance...
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