The US Food and Drug Administration (FDA) has approved ustekinumab-srlf (Imuldosa) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions. This is the fifth ...
FDA approves Pfizer’s Hympavzi for routine prophylaxis in hemophilia A and B patients, offering a once-weekly dosing via auto-injector pen. Phase 3 trial showed Hympavzi reduced bleeding rates ...
The FDA approval of HYMPAVZI was supported by the Phase III BASIS clinical trial. Credit: Andrey_Popov/Shutterstock. Pfizer has announced the approval of HYMPAVZI ...
This is the second biosimilar approved in the US from Amgen and Allergan’s partnership, which has already got a biosimilar to Roche’s Avastin (bevacizumab) cancer drug backed by the FDA.
Novocure received a long-sought FDA approval for the use of its Tumor Treating Fields technology against metastatic non-small cell lung cancer—which the company described as the first treatment ...
Stelara is also one of the first 10 medications selected by CMS for drug price negotiation, which will go into effect at the start of 2026. Imuldosa is the fifth Stelar biosimilar to be approved for ...
In its second attempt, Takeda has secured FDA approval for Eohilia ... oral suspension formulation of the well-established steroid drug budesonide, for people 11 years and older with EoE after ...