The American Journal of Managed Care13 天
FDA Approves Imuldosa, a Fifth Biosimilar to Stelara
The FDA has approved Imuldosa (ustekinumab-srlf), a biosimilar referencing Stelara (ustekinumab), for the treatment of autoimmune diseases such as plaque psoriasis, psoriatic arthritis ...
Medscape9 天
FDA Approves Fifth Ustekinumab Biosimilar
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 ...
Benzinga.com9 天
FDA Approves Pfizer's Second Hemophilia Drug With Six Months
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 ...
FiercePharma5 天
Astellas nabs class-first FDA approval for CLDN18.2 gastric cancer med Vyloy
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 ...
Medscape13 天
FDA Approves Pfizer's Hympavzi for Hemophilia A, B
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 ...
pharmaphorum5 天
FDA approves Herceptin biosimilar as US patent expires
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 ...
centerforbiosimilars13 天
FDA Approves Imuldosa, a Biosimilar to Stelara
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 ...
Yahoo Finance6 天
FDA Approves AbbVie's Parkinson's Treatment, Medicare Coverage Expected Next Year
On Thursday, the FDA approved AbbVie Inc’s (NYSE:ABBV) Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for motor fluctuations ...
WebMD24 天
FDA Approves First Injectable for Relapsing and Progressive MS
The FDA has approved a new injectable form of the multiple sclerosis drug ocrelizumab for use in adults with relapsing and progressive forms of the disease. Multiple sclerosis occurs when the body ...
Time26 天
FDA Approves the First New Schizophrenia Drug in Decades
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 ...
Medical Xpress27 天
FDA approves new kind of drug for schizophrenia
"This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed." According to the FDA, about 1% of people have schizophrenia ...