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...
Boehringer Ingelheim and G1 Therapeutics Announce COSELA Now Commercially Available in US
Boehringer Ingelheim and G1 Therapeutics have announced that the injection of COSELA™ (trilaciclib) is now commercially available in the US. COSELA, the only U.S. Food and Drug Administration (FDA)-approved treatment that is meant to decrease the incidence of...
BridgeBio & Origin BioSciences’ Therapy for Rare Disease
The U.S. Food and Drug Administration (FDA) approved today NULIBRY™ (fosdenopterin), a treatment developed by BridgeBio and its affiliate Origin Biosciences for molybdenum cofactor deficiency (MoCD) Type A. MOCD Type A is an extremely rare metabolic disorder that...
FDA Clears IND Application for Flexion Therapeutics’ FX301
The U.S. Food and Drug Administration (FDA) cleared Flexion Therapeutics’ Investigational New Drug (IND) application for FX301, a locally administered NaV1.7 inhibitor for post-operative pain. The clearance came after the FDA reviewed preclinical data that was...
FDA Approves Targeted Treatment for Duchenne Muscular Dystrophy
The U.S. Food and Drug Administration (FDA) approved Amondys 45 (casimersen) injection from Sarepta Therapeutics for the treatment of Duchenne muscular dystrophy (DMD) in patients that have a mutation amenable to skipping exon 45. DMD is a genetic disorder that causes...