FDA Authorizes All ZYN Nicotine Pouch Products Currently Marketed by Swedish Match in the U.S.

Richmond, Va., United States:   FDA decision makes ZYN the first authorized nicotine pouch product Science-based decision affirms that ZYN nicotine

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Galderma Receives U.S. FDA Approval for Nemluvio® (Nemolizumab) for Patients with Moderate-to-Severe Atopic Dermatitis

Zug, Switzerland:   Ad hoc announcement pursuant to Art. 53 LR   Approximately 7% of people in the United States

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U.S. FDA Approves AOP Health’s Rapiblyk™ (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting

Vienna, Austria:   AOP Orphan Pharmaceuticals GmbH (AOP Health), based in Vienna, Austria, announced that the U.S. Food and Drug Administration

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US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (denosumab)

Shanghai, China & JERSEY CITY, N.J., United States:   Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the

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Paragonix Technologies receives FDA 510(k) clearance for KidneyVault portable renal perfusion system

Paragonix Technologies, a leading organ preservation company recently acquired by Getinge, receives FDA clearance for the innovative transportable perfusion device KidneyVault,

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Environmental Factor – March 2020: FDA reviews asbestos testing in cosmetics and powders

The U.S. Food and Drug Administration (FDA) hosted a public meeting Feb. 4 to hear comments about improving test methods for detecting asbestos and similar minerals

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Fujirebio Submits FDA Regulatory Filing for Lumipulse® G pTau 217/ß-Amyloid 1-42 Plasma Ratio In-Vitro Diagnostic Test as an Aid to Identify Patients With Amyloid Pathology Associated With Alzheimer’s Disease

TOKYO, Japan & MALVERN, Pa., United States:   —Expected to Be First Commercially-Available Blood-Based In-Vitro Diagnostic for Patients Being Assessed for

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Environmental Factor – May 2021: FDA chief scientist presents 20th annual NIEHS Spirit Lecture

Rear Admiral Denise Hinton, chief scientist of the U.S. Food and Drug Administration (FDA), inspired listeners at the 20th annual NIEHS Spirit Lecture on April

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Implantica announces finalization of remarkable 5-year pivotal CE mark study results and gears up for the Module 2 submission of PMA application to FDA for RefluxStop™

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including a unique device

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Neu-REFIX Beta glucan receives rare pediatric disease and orphan drug designations from the US FDA for treatment of Duchenne Muscular Dystrophy

TOKYO, Japan:   Neu REFIX Beta glucan, made in Japan has received both Rare Pediatric Disease Designation (RPDD) and Orphan Drug

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