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Swissmedic Approval: BeiGene’s BRUKINSA to Treat WM

Swissmedic Approval: BeiGene’s BRUKINSA to Treat WM

Feb 18, 2022 | News, Regulatory

BeiGene has announced their Bruton’s tyrosine kinase (BTK) inhibitor BRUKINSA (zanubrutinib) has been approved by Swissmedic to treat adult patients with Waldenström’s macroglobulinemia (WM). WM is a rare B-cell lymphoma that is primarily found in bone marrow and...
FDA Approval: Prophylactic Treatment for Type 3 VWD

FDA Approval: Prophylactic Treatment for Type 3 VWD

Jan 31, 2022 | FDA, News, Regulatory

The U.S. Food and Drug Administration (FDA) has approved Takeda Pharmaceutical’s VONVENDI to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand disease (VWD). VWD is the most common inherited bleeding disorder that is caused by a...
FDA Approves Thermo Fisher’s CDx Cancer Tissue Test

FDA Approves Thermo Fisher’s CDx Cancer Tissue Test

Dec 10, 2021 | FDA, News, Regulatory

The U.S. Food and Drug Administration (FDA) has granted premarket approval for Thermo Fisher’s Oncomine Dx Target Test as a companion diagnostic (CDx) developed to help identify non-small cell lung cancer (NSCLC) patients. Lung cancer is the leading cause of...
Pfizer COVID-19 Vaccine Received Full FDA Approval

Pfizer COVID-19 Vaccine Received Full FDA Approval

Aug 24, 2021 | FDA, News, Regulatory

Marketed under the name, Comirnaty, The US FDA (Food and Drug Administration) granted the Pfizer-BioNTech COVID-19 vaccine full approval yesterday, the first COVID-19 vaccine to become fully licensed in the US. In the US, the vaccine is now approved for people aged 16...