FiercePharma2d
EMA backs Merck’s Welireg, Bayer’s ATTR med and Gilead’s liver drug from $4.3B deal
Merck & Co.’s kidney cancer drug Welireg, Bayer and BridgeBio’s transthyretin amyloid cardiomyopathy (ATTR-CM) therapy, and ...
Europe allows Novo to include reduction of kidney disease in Ozempic label
The European Medicines Agency (EMA) will allow Novo Nordisk to add risk reduction for events related to kidney disease to the ...
Antidepressant Recall Update As FDA Sets Risk Level
233,003 bottles of duloxetine have been recalled due to potentially containing high levels of cancer-causing impurities.
Bayer Gets EU Backing for Heart Drug, Easing Patent Concerns
Bayer AG won the backing of European Union regulators for its cardiology drug as the German company fights to offset the ...
Medscape2d
EMA Supports Expanding Use of Ofev to Pediatric ILDs
Europe’s medicines regulator has backed a pediatric indication for Ofev to treat progressive fibrosing interstitial lung ...
Novo Nordisk's Ozempic Label Expansion Snags Approval From European Drug Regulator's Advisory Panel
Novo Nordisk's Ozempic gains positive EMA opinion for label update after FLOW trial data show significant kidney and ...
MarketWatch2d
Gilead Gets Key European Backing for Liver-Disease Treatment
The biopharmaceutical company Friday said the recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use covers seladelpar in combination with ...
Medscape2d
Rytelo Recommended in Europe for Myelodysplastic Syndromes
The European Medicines Agency (EMA) has given a positive recommendation for Rytelo ( imetelstat) for the treatment of adult ...