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  1. financialpost.com › globe-newswire › fda-approves-biosimilarFDA approves biosimilar Pyzchiva® (ustekinumab-ttwe), to be ...

    5 days ago · Basel, July 1, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) has approved biosimilar Pyzchiva®* (ustekinumab-ttwe) 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection and 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion.

  2. www.medthority.com › news › 2024Sandoz + Samsung Bioepis' Pyzchiva,(ustekinumab-ttwe), a...

    4 days ago · Sandoz, the global leader in generic and biosimilar medicines, announced that the FDA has approved biosimilar Pyzchiva (ustekinumab-ttwe) 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection and 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion

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  4. www.dermatologytimes.com › view › fda-approves-biosimilarFDA Approves Biosimilar Ustekinumab-ttwe for All Indications of...

    5 days ago · The US Food and Drug Administration (FDA) has granted approval to Pyzchiva (ustekinumab-ttwe), a biosimilar developed by Samsung Bioepis Co., Ltd., to be commercialized by Sandoz in the United States. 1. The approval encompasses all indications of its reference medicine, including treatments for adult and pediatric patients with moderate to ...

  5. markets.businessinsider.com › news › stocksSandoz To Commercialize Samsung Bioepis' FDA Approved Biosimilar...

    5 days ago · Jul. 1, 2024, 01:31 AM. (RTTNews) - Sandoz Group AG (SDZNY), a Swiss maker of generic and biosimilar medicines, announced Monday that the US Food and Drug Administration has approved biosimilar ...

  6. www.fiercepharma.com › pharma › regulatory-tracker-second-halfRegulatory tracker: Sandoz, Samsung Bioepis gain FDA approval for...

    5 days ago · Sandoz and Samsung Bioepis' Pyzchiva, ... to spread to areas in Europe that were previously unaffected," Valneva's chief medical officer, Juan Carlos Jaramillo, M.D., said in a statement. ...

  7. drugstorenews.com › sandoz-obtains-fda-nod-stelara-biosimilarSandoz obtains FDA nod for Stelara biosimilar | Drug Store News

    3 days ago · Sandoz has received the Food and Drug Administration’s permission for Pyzchiva (ustekinumab-ttwe), 45 mg/0.5 ml and 90 mg/ml pre-filled syringes for subcutaneous injection and 130 mg/26 ml (5 mg...

  8. www.drugs.com › medical-answers › many-biosimilars-approvedWhat biosimilars have been approved in the United States? -...

    4 days ago · There are currently 57 biosimilars approved by the U.S. Food and Drug Administration (FDA). The most recent biosimilar approvals were Nypozi (filgrastim-txid), Pyzchiva (ustekinumab-ttwe) and Ahzantive (aflibercept-mrbb) on June 28, 2024.