The companies hope that the US regulator approves patisiran and lorlatinib.
A new influenza antiviral from Roche and Shionogi could become an important new medicine for both groups, if payers can be convinced.
2018 shaping up to be a bumper approval year, as Juno Therapeutics, Epizyme and Avexis line up to launch potential blockbusters.
FDA back in business after 2016's fall in drug approvals.