Pharma & Biotech - Page 2

Ultragenyx Pharmaceutical (RARE) has earned its first FDA approval in gene therapy, landing an accelerated green light for its treatment targeting glycogen storage disease type Ia. The FDA approved pariglasgene brecaparvovec-opnr, previously

Boehringer Ingelheim has strengthened its position among the most respected companies in rare disease, building on significant gains recorded in the previous year’s survey. The German drugmaker climbed another four places in

CDMO SK Pharmteco has completed two advanced manufacturing facilities at its production campus in Swords, Ireland, significantly expanding its pharmaceutical ingredient capabilities. The company first announced plans for a phased expansion at

SK Biopharmaceuticals has struck its first-ever settlement with a generic drug manufacturer seeking to produce a copycat version of its epilepsy treatment Xcopri (cenobamate). The agreement is with India’s MSN Laboratories, which

Regeneron Pharmaceuticals (REGN) has secured a landmark FDA approval for its monoclonal antibody garetosmab, now commercially known as Pasatru, after more than ten years in development. The drug becomes the second FDA-cleared

President Donald Trump is expected to nominate Heidi Overton, a physician and White House domestic policy aide, to lead the Food and Drug Administration. The move, reported by a source familiar with

Aurobindo Pharma’s sterile injectables and oncology division Eugia has received a fresh FDA Warning Letter following an inspection of its Pharma Specialties facilities in Hyderabad in February. The warning letter comes after

Pharmacovigilance is undergoing a fundamental shift as artificial intelligence transforms how pharmaceutical companies detect, monitor, and respond to drug safety signals. Writing for Pharmaceutical Commerce, Updesh Dosanjh of IQVIA argues that AI-powered

Valeris, the integrated life sciences commercialization company, has appointed Scott Filosi as its new Chief Commercial Officer, effective immediately. Filosi will take responsibility for leading Valeris’s entire commercial organisation, with a sharp

Biokin Pharma’s iza-bren has recorded another significant clinical victory, meeting the primary endpoint of its Panku-Lung01 lung cancer phase 3 trial at an interim analysis. The Chinese drugmaker disclosed the result in