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…
Esperion shifts to show not tell
After spending years insisting that its cholesterol-lowering medicine has a place between statins and PCSK9 inhibitors, Esperion must now prove it.
First fragile X test is approved, and Zynerba could benefit
The fragile X pipeline is strewn with failures, and crunch time is approaching for Zynerba’s cannabinoid.
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.
Olympus banks on acquisitions to sustain its high
A strategic change towards Olympus's medical business, and particularly therapeutic procedures, has reignited growth. Next up: acquisitions.
US FDA approval tracker: a first for Aimmune
January saw Aimmune receive an FDA approval for Palforzia, a first for peanut allergy, alongside decisions for Blueprint Medicines and Horizon Therapeutics.
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.
