Browsing Tag
US Food and Drug Administration
348 posts
Ensemble Orthopedics secures FDA clearance for innovative CMC implant for osteoarthritis treatment
Ensemble Orthopedics, a Texas-based medical device company, has secured 510(k) clearance from the US Food and Drug Administration…
Novo Nordisk secures FDA approval for Saxenda label update targeting adolescent obesity treatment
Novo Nordisk, a global leader in diabetes and obesity care, has received approval from the US Food and…
Protalix BioTherapeutics receives FDA extension for pegunigalsidase alfa review: What this means for Fabry disease treatment
Protalix BioTherapeutics, a leader in the development of innovative therapies for rare diseases, has announced a significant update…
Merck seeks FDA and EMA approvals for V114 pneumococcal conjugate vaccine candidate
Merck & Co., a global leader in pharmaceutical development, has submitted applications to the US Food and Drug…
FDA accepts SB11 BLA for review: A step towards affordable treatment for retinal vascular disorders
The United States Food and Drug Administration (FDA) has recently accepted the biologics license application (BLA) for SB11,…
ExeGi Pharma’s EXE-346 receives FDA orphan drug designation for pouchitis treatment
ExeGi Pharma, a biotechnology company headquartered in Rockville, Maryland, has announced that its live biotherapeutic product (LBP), EXE-346,…
FDA grants emergency use authorization for Bamlanivimab to treat Covid-19
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for bamlanivimab (LY-CoV555), a neutralizing…
Janssen seeks expanded approval for DARZALEX in treating AL amyloidosis
Janssen Pharmaceutical Companies of Johnson & Johnson has recently submitted a Type II variation application to the European…
OliX Pharmaceuticals seeks FDA nod for phase 2a trial of OLX10010
OliX Pharmaceuticals, a South Korean pharma company, has submitted an investigational new drug (IND) application to the US…
Kazia Therapeutics gets US RPDD for paxalisib in childhood brain cancer
Kazia Therapeutics, an Australian biotech company, has secured the rare pediatric disease designation (RPDD) for paxalisib (formerly GDC-0084)…