Go or no go? A busy month ahead for US FDA decisions
June will be hectic for the US regulator, with many approval decisions due, including one for subcutaneous Arzerra in multiple sclerosis and Tazverik in follicular…
Upcoming events – Milestone's milestone and Transmedics' panel
Soon Milestone will report pivotal data with etripamil, an intranasal heart arrhythmia therapy, and an FDA adcom approaches for Transmedics' heart preservation…
Go or no go? Ozanimod and Fintepla await FDA verdicts
Big approval decisions pending in March include ozanimod in multiple sclerosis, where Bristol-Myers is likely to win a green light, while the safety of Zogenix's…
FDA keeps the faith in surrogate endpoints
The US regulator granted 14 accelerated approvals in 2019, fewer than in the previous two years, and the sector remains slow at conversions.
Go or no go? Esperion's double whammy and a look to priority reviews
Four assets with previous rejections are due FDA decisions in February, while those with priority review could become the next string of early approvals.
Rare diseases top another strong year for novel drug approvals
A clutch of swift FDA decisions boosted average US drug approval times in 2019, helping biopharma to deliver another bumper crop of new medicines.
Another blockbuster year looms for approvals
Biogen’s Alzheimer’s candidate and Fibrogen’s new anaemia pill top the list of the biggest commercial hopes that could reach the market in 2020.
Morphosys gets a major tafasitamab endorsement
Incyte hands across $750m up front and buys $150m of Morphosys equity for rights to the anti-CD19 project.
Clinical developments over the Christmas period
The most important clinical readouts of the holiday period concerned Google Health, Axsome, Wave and Spectrum.
