Astrazeneca gets one over on Sanofi and Lexicon with European approval for Forxiga. US regulators might not be so forgiving.
The commercial potential of last year’s new medicines suggests another strong year of productivity from biopharma, while a further analysis reveals the arrival of two…
Changes at the FDA have altered the device approval landscape, with the de novo route now the most popular.
Was 2018 as good as it gets for drug approvals, or is the pipeline so stellar that even a US government shutdown cannot stop biopharma?
If the recent performance of biotech stocks prompted you to pull down the shutters until the New Year celebrations subsided here’s what you might have missed.
Launch could be trickier than approval, not least because of problems diagnosing patients with primary haemophagocytic lymphohistiocytosis.
The final month of 2018 will see FDA verdicts on Roche’s bid to play in the first-line lung cancer space, and what Jazz hopes will be its next big narcolepsy product.
Bayer tests what the market will bear for its newly approved therapy for cancers with NTRK mutations.
Amid market volatility, biotech’s best friend comes through once again: the FDA has authorised a bumper 53 new medicines so far in 2018 and several more are expected…