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...
FDA Partially Rescinds Two Supplemental Biologics License Applications
The Center for Biologics Evaluation and Research (CBER), part of the U.S. Food and Drug Administration (FDA), partially rescinded two approvals of supplemental biologics license applications (sBLAs) for recombinant factor IX products. The sBLAs were approved by the...
Sinopharm Unit and CanSinoBio apply for Public Use Approval of COVID-19 Vaccine in China
Sinopharm, a unit of the China National Pharmaceutical Group, and CanSinoBiologics Inc both have applied in China for the public use of their COVID-19 vaccines. Currently, China has two approved vaccines that were developed within the country, and has yet to approve...