The US Food and Drug Administration (FDA) has given approval to Takeda’s supplemental Biologics License Application (sBLA) for the expanded use of TAKHZYRO (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients 2 to less than 12 years of age.
Spruce Biosciences and Kaken Pharmaceutical have signed an exclusive licensing agreement for the development and commercialisation of Spruce’s product candidate, tildacerfont, to treat congenial adrenal hyperplasia (CAH) in Japan.
Novartis has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Cosentyx (secukinumab) for usage either alone or in combination with methotrexate.
AbbVie has submitted applications seeking approval for SKYRIZI (risankizumab-rzaa, 150 mg) and SKYRIZI (risankizumab, 150 mg) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively, for the treatment of adults with active psoriatic arthritis.
The U.S. Food and Drug Administration (FDA) has approved Emergency Use Authorization (EUA) for investigational bamlanivimab and etesevimab as a combination therapy for the treatment of mild to moderate Covid-19 patients.
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