The approval was anchored on data from the pivotal DEVOTE study that investigated the efficacy and safety of the High Dose Regimen of SPINRAZA in ...

After Spinraza's FDA approval nearly a decade ago, Biogen's spinal muscular atrophy (SMA) drug captured rapid momentum and delivered blockbuster-level sales in just its second year on the market. | ...

The new approval allows for the 2000mg loading dose to be administered as an IV push rather than a 30-minute IV infusion. The prescribing information for Trogarzo ® (ibalizumab-uiyk) has been updated ...

This news release constitutes a “designated news release” for the purposes of the Company’s prospectus supplement dated December 16, 2021 to its short form base shelf prospectus dated December 14, ...

Ultomiris (ravulizumab-cwvz) is a brand-name drug prescribed for certain autoimmune conditions. Ultomiris is given as an intravenous (IV) infusion by a healthcare professional. The drug’s dosing ...

"Pending prospective PK [pharmacokinetics]/PD [pharmacodynamics]-guided confirmation, a LD [loading dose] regimen followed by maintenance q8h [every 8 hours] may represent a rational, safe, and ...