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 ...

The FDA has approved Imuldosa (ustekinumab-srlf), a biosimilar referencing Stelara (ustekinumab), for the treatment of autoimmune diseases such as plaque psoriasis, psoriatic arthritis ...

After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. The FDA on Friday gave Vyloy (zolbetuximab) the thumbs-up ...

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 US Food and Drug Administration (FDA) has approved Hympavzi (marstacimab, Pfizer) as routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients 12 years or older ...

Roche (ROG.S), opens new tab said on Friday that the FDA had approved its companion diagnostic test to identify patients who may be eligible for Vyloy. The FDA had previously declined to approve ...

Imuldosa (ustekinumab-srlf) is the fifth ustekinumab biosimilar referencing Stelara to receive regulatory approval in the US. The FDA has approved Imuldosa (ustekinumab-srlf), a biosimilar referencing ...

For this approval, the FDA required human factors/usability studies to determine if patients aged 18 to 49 years could appropriately administer FluMist. 2 The results showed that 100% of intended ...

The FDA has approved Amgen and Allergan’s biosimilar of Roche’s Herceptin, just in time for the breast cancer blockbuster’s patent expiry. Herceptin’s main US patent expires this month ...

No new treatments for schizophrenia have been approved in nearly three decades, but that changed on Sept. 26, when the U.S. Food and Drug Administration (FDA) approved Cobenfy for the psychiatric ...

Credit: Kateryna Kon/Shutterstock. Zevra Therapeutics has announced US Food and Drug Administration (FDA) approval for Miplyffa (arimoclomol) to treat Niemann-Pick disease type C (NPC). The capsules ...

On Thursday, the FDA approved AbbVie Inc’s ABBV Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for motor fluctuations in ...