The European Medicines Agency (EMA) offered guidance on labeling requirements for COVID-19 therapeutics as a follow up on their guidance from last year that offered labeling requirement flexibilities on COVID-19 vaccinations. According to the EMA, the product’s...
The U.S. Food and Drug Administration (FDA) granted approval for revised commercial labeling of Medtronic’s Intellis™ Platform with Differential Target Multiplexed (DTM™). The platform is meant to treat chronic and intractable leg and back pain. Charlie Covert,...
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 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...
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...
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...
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