Locate Bio, a UK-based orthobiologics company, has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for LDGraft.
Lumen Bioscience has announced that the US Food and Drug Administration (FDA) has granted fast track designation for LMN-201, its biologic drug to treat and prevent C. difficile infection (CDI).
SiSaf has been granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (PRDD) by the US Food and Drug Administration (FDA) for its osteopetrosis treatment, SIS-101-ADO.
Memo Therapeutics, a biotech company developing therapeutic antibodies, has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to AntiBKV.
The U.S. Food and Drug Administration (FDA) has approved bluebird bio’s Zynteglo (betibeglogene autotemcel), also known as beti-cel: a one-time gene therapy custom-designed to treat the underlying genetic cause of beta thalassemia in adult and pediatric...
The US agency has approved Enhertu for patients diagnosed with HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regimen.
The drug, intended for adult patients with moderate-to-severe systemic lupus erythematosus, is the only new therapy approved for SLE in more than a decade.
Shortly after EMA’s approval, the US FDA follows with a positive nod for Ervebo, the first vaccine to receive approval for the prevention of Ebola virus disease.
The FDA approves an IND application from ActoBio for AG017, an oral biologic drug candidate for the reversal of celiac disease, a condition which currently has no approved treatments.
Amgen’s biosimilars portfolio reaches a milestone after its Herceptin biosimilar, Kanjinti, developed in collaboration with Allergan, was approved by the US FDA.
Novartis investigates the death of an infant in a gene therapy clinical trial to determine whether it was related to the treatment but does not anticipate an impact on FDA approval.
The US FDA has approved Genentech’s auto-injector formulation of Actemra, which the firm says offers an additional administration option for patients and caregivers.
Eli Lilly’s migraine treatment was approved by the US FDA, closely following a positive CHMP opinion, and will potentially be made available without cost for the first year.
