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Latest From Jessica Merrill
Global oncology sales grew 45% to $2.31bn in the first quarter, powered by strong growth of Darzalex, Imbruvica and Zytiga, narrowing the gap with J&J's top-selling immunology franchise.
US FDA accepts Alkermes' NDA for depression drug after issuing refuse-to-file letter just two weeks ago; unusual move falls outside agency's guidance on RTFs because no changes were made to submission and it wasn't filed over protest.
Reversing an earlier decision, FDA accepted Alkermes' new drug application (NDA) for ALKS 5461 for review, with a target action date of Jan. 31. But the company could still face a tough FDA review.
Keeping Track: FDA Delays Elagolix, Mylan Eyes For Neulasta Biosimilar Approval, And Duvelisib Gets Priority Review
The latest drug development news and highlights from our US FDA Performance Tracker.
A biosimilar of Amgen's Neulasta appears on track for FDA approval by the June 4 action date, management said during an investor briefing that showcased Mylan's expansive biosimilar pipeline. Mid- to late-stage copies of products like Advair, Symbicort, Herceptin, Humira, Avastin, Rituxan, Eylea and Botox highlight the strategic direction Mylan moved in nearly a decade ago.
Essential Health Group President Angela Hwang, Biosimilars President Richard Blackburn and US Biosimilars General Manager John Kennedy discuss the early challenges Pfizer has faced with Inflectra and optimism for the US biosimilars market over the long term.