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Alvotech and Teva Announce U.S. FDA Approval of Additional Presentation of SELARSDI™ (ustekinumab-aekn), Expanding its Label to Include Further Indications Approved for Reference Product, Stelara® (ustekinumab)

Alvotech and Teva Announce U.S. FDA Approval of Additional Presentation of SELARSDI™ (ustekinumab-aekn), Expanding its Label to Include Further Indications Approved for Reference Product, Stelara® (ustekinumab)

Approval of SELARSDI 130 mg/26 mL in a single-dose vial for intravenous infusion expands label to include treatment of adults with Crohn’s disease and ulcerative colitis The FDA previously approved SELARSDI 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection in April 2024 SELARSDI’s U.S. launch for all indications is [...]

Sandoz Receives FDA Approval for Enzeevu™ (aflibercept-abzv), Further Strengthening US Biosimilar Position

Sandoz Receives FDA Approval for Enzeevu™ (aflibercept-abzv), Further Strengthening US Biosimilar Position

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules Enzeevu™ (aflibercept-abzv) approved to treat neovascular age-related macular degeneration Further enhances leading US ophthalmology portfolio and increases access for patients Expected to be key biosimilar growth driver in US Basel, August 12, 2024 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, [...]

Nyxoah Submits Fourth and Final Module in PMA Application for Genio to the US FDA

Nyxoah Submits Fourth and Final Module in PMA Application for Genio to the US FDA

Nyxoah Submits Fourth and Final Module in PMA Application for Genio to the US FDA Mont-Saint-Guibert (Belgium), July 1, 2024, 8:00am CET / 2:00am ET – (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the Company submitted the fourth and final module [...]

FDA Approves Biosimilar Pyzchiva® (ustekinumab-ttwe), to Be Commercialized by Sandoz in US

FDA Approves Biosimilar Pyzchiva® (ustekinumab-ttwe), to Be Commercialized by Sandoz in US

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules Pyzchiva® (ustekinumab-ttwe) is approved by FDA for all indications of reference medicine FDA granted provisional determination for interchangeability designation for Pyzchiva® Extends Sandoz immunology portfolio and further strengthens biosimilar position Expected to be among first wave of ustekinumab biosimilars to launch in US [...]

Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW171, a novel 2+1 T-cell Targeting Bispecific Antibody for Mesothelin-expressing Cancers

Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW171, a novel 2+1 T-cell Targeting Bispecific Antibody for Mesothelin-expressing Cancers

VANCOUVER, British Columbia, June 17, 2024 (Korea Bizwire) – Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for ZW171, [...]

Sandoz Receives FDA Approval for First and Only Denosumab Biosimilars

Sandoz Receives FDA Approval for First and Only Denosumab Biosimilars

Wyost® (denosumab-bddz) and Jubbonti® (denosumab-bddz) interchangeable with and approved by FDA for all indications of reference medicines Xgeva ®* (denosumab) and Prolia®* (denosumab) FDA approval based on robust clinical studies and totality of evidence, which show no clinically meaningful differences from reference medicines Basel, March 5, 2024 (Korea Bizwire) – Sandoz, the global leader in generic and biosimilar medicines, [...]

S. Korean Coronavirus Test Kit Firms Earn U.S. FDA Pre-approval

S. Korean Coronavirus Test Kit Firms Earn U.S. FDA Pre-approval

SEOUL, March 29 (Korea Bizwire) — Three South Korean COVID-19 test-kit companies have obtained preliminary approval from the U.S. Food and Drug Administration (FDA), the foreign ministry said Saturday. The initial FDA approval will allow the Korean test-kit makers to sell the products in the United States, where the number of confirmed coronavirus cases has [...]