FDA Approvals

Bristol-Myers Squibb Company announced that Opdivo (nivolumab) received approval from the U.S. FDA as the first and only Immuno-Oncology treatment...

Eisai Inc. and Merck , known as MSD outside of the United States and Canada , announced that the U.S....

The U.S. FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of...

The U.S. FDA approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease. The drug...

The European Commission has granted marketing authorisation for Tagrisso (osimertinib) as monotherapy for the 1st-line treatment of adult patients with...

Eli Lilly and Company and Incyte Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved the...

Gilead Sciences, Inc. announced that the U.S. FDA has approved once-daily oral Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)—in...

Novartis announced that the US FDA expanded the indication for Tasigna  (nilotinib) to include treatment of first- and second-line pediatric...

Pharmapack Europe (#pharmapackeu) – organised by UBM – closed its most exciting edition to date, taking place at Paris Expo,...