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…
Covid-19 adds a new danger to drug launches
Launch phase is a challenging time for drug developers, so consider the likes of Biohaven, Esperion and, most recently, Urogen, as they brave locked-down markets.
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.
A handful of huge gains stand out among mid and small-cap biotechs
Drug makers from across the globe feature in 2019’s list of best performing small biotech stocks, from Galapagos to Daiichi Sankyo to Arrowhead.
Go or no go? Enhertu’s destiny revealed and FDA decisions due for Epizyme, Novo
Enhertu gets an early thumbs up from the FDA – now decisions are due for Epizyme’s tazemetostat and Novo Nordisk's Rybelsus and Ozempic.
Esmo 2019 preview – Parps on parade
Among small-molecule approaches Europe’s premier oncology conference gives star billing to three Parp inhibitors in ovarian cancer.
Asco 2019 event analyser – low-key meeting belies some huge stock moves
Mirati Therapeutics nearly stole the show at Asco despite not actually presenting – a fact that illustrates how low on meaningful data this year's conference was.