Soon Milestone will report pivotal data with etripamil, an intranasal heart arrhythmia therapy, and an FDA adcom approaches for Transmedics' heart preservation…
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…
After spending years insisting that its cholesterol-lowering medicine has a place between statins and PCSK9 inhibitors, Esperion must now prove it.
The fragile X pipeline is strewn with failures, and crunch time is approaching for Zynerba’s cannabinoid.
The US regulator granted 14 accelerated approvals in 2019, fewer than in the previous two years, and the sector remains slow at conversions.
A strategic change towards Olympus's medical business, and particularly therapeutic procedures, has reignited growth. Next up: acquisitions.
January saw Aimmune receive an FDA approval for Palforzia, a first for peanut allergy, alongside decisions for Blueprint Medicines and Horizon Therapeutics.
Four assets with previous rejections are due FDA decisions in February, while those with priority review could become the next string of early 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.