USFDA Clears Smith+Nephew's Stemless Shoulder Implant for AETOS System

Smith+Nephew, the worldwide medical technology firm, announces it has obtained 510(k) authorization from the United States Food & Drug Administration for a stemless anatomical total shoulder for the AETOS Shoulder System (AETOS Stemless). AETOS...

USFDA Grants Tentative Approval for Lasix ONYU in Heart Failure Treatment

Gerresheimer, a creative systems and solutions provider and a worldwide partner for the pharmaceutical, biotech, and cosmetics sectors, has announced that the US Food and Drug Administration (FDA) has granted SQ Innovation Tentative Approval for...

US FDA Nods Ascendis Pharma's sBLA for TransCon hGH in Adult GHD

Ascendis Pharma A/S, a worldwide pharmaceutical firm utilizing its cutting-edge TransCon technology platform to develop a prominent and fully integrated biopharma business dedicated to significantly improving patients' lives, reported that the US...

UK MHRA Approves Sparsentan for IgA Nephropathy Treatment

The MHRA in the UK has given the approval to sparsentan (Filspari) for the treatment of IgAN. Berger's disease, or IgA neuropathy, is a kidney condition caused by the accumulation of immunoglobulin A (IgA) antibodies in the kidneys. Sparsentan...

US FDA Nods paediatric disease and orphan-drug designation to treat LGMD

Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company fully owned and autonomously operating as a subsidiary of Bayer AG, announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug...

FDA Approves Bayer's MEDRAD Centargo CT Injection System

Bayer revealed that it received approval from the U.S. Food and Drug Administration (FDA) for its MEDRAD® Centargo CT Injection System, a groundbreaking multi-patient injector that enhances workflow efficiency through design elements that align...

US FDA Nods Special Designation to Boost Rare Pediatric Drug Development

The US FDA awards Rare Paediatric Disease Designation to encourage the development of drugs for serious conditions impacting fewer than 200,000 children in the US. Since these illnesses present distinct hurdles for drug development...

EMA Approves Dupixent as Treatment for Eosinophilic Esophagitis in Children

The European Medicines Agency has authorized Dupixent (dupilumab) for the treatment of eosinophilic esophagitis (EoE) in children starting from one year old. The approval specifically pertains to children between the ages of one and 11 years who...

FDA Clears Journey Medical's Emrosi for Rosacea Treatment

The US FDA has given approval for Journey Medical's Emrosi, a brand name for their 40mg minocycline hydrochloride extended-release capsules, for treating the skin condition rosacea. Created with the help of Dr Reddy's Laboratories, Emrosi...

US FDA Approves Protega Pharma's Roxybond

Protega Pharmaceuticals Inc., a unique specialty pharmaceutical company dedicated to ethical pain control and creating new abuse-resistant products, revealed that the US Food and Drug Administration (FDA) has given the green light for Roxybond...