The White House is ex­am­in­ing a deal re­cent­ly reached by the FDA and the bio­phar­ma in­dus­try that sets the pre­scrip­tion drug user fees that the...

A bi­par­ti­san group of Michi­gan law­mak­ers re­leased a new bill that could great­ly sti­fle the boom­ing cross-bor­der deals spree be­tween Chi­nese and Amer­i­can biotechs.

Rep...

The FDA is fur­ther ex­plain­ing to cell and gene ther­a­py de­vel­op­ers the types of pri­or knowl­edge com­pa­nies can lever­age for clin­i­cal, non­clin­i­cal and man­u­fac­tur­ing-re­lat­ed work...

Bio­phar­ma com­pa­nies prepar­ing to launch the next prac­tice-chang­ing block­busters want pay­ors to know what's com­ing be­fore they ul­ti­mate­ly land an FDA ap­proval. The trick is...

How much is a reg­u­la­to­ry short­cut worth?

The cost of a pri­or­i­ty re­view vouch­er, which short­ens the FDA’s stan­dard re­view time by about four months...

Third time’s the charm?

Replimune an­nounced Fri­daythat it will sub­mit its ad­vanced melanoma drug RP1 for FDA re­view af­ter two pri­or re­jec­tions. It said...

Japan's Sh­iono­gi on Mon­day said it won FDA ap­provalfor its oral an­tivi­ral to pre­vent Covid‑19 in adults and chil­dren old­er than 12 years who...