FDA Approvals

Roche announced that the US FDA has approved Xofluza™ (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years...

EC approves new easy-to-use, once-weekly Bydureon BCise device for patients with type-2 diabetes

FDA Approvals

AstraZeneca announced that the EC has approved Bydureon BCise as a new formulation within the marketing authorisation for Bydureon for the treatment of patients...

Exact Sciences and Pfizer Enter into U.S. Promotion Agreement for Cologuard®

FDA Approvals

Exact Sciences Corp and Pfizer Inc. announced an agreement through 2021 to co-promote Cologuard, the first and only FDA-approved non-invasive stool DNA screening test...

U.S. FDA approves opdivo as the first new medication in nearly 20 years for certain patients with previously treated small cell lung cancer

FDA Approvals

Bristol-Myers Squibb Company announced that Opdivo (nivolumab) received approval from the U.S. FDA as the first and only Immuno-Oncology treatment option for patients with...

Eisai And Merck announce FDA approval of LENVIMA capsules for first-line treatment of Unresectable Hepatocellular Carcinoma

FDA Approvals

Eisai Inc. and Merck , known as MSD outside of the United States and Canada , announced that the U.S. FDA approved the kinase...

FDA approves first generic version of EpiPen

FDA Approvals

The U.S. FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those...

FDA approves new treatment for a rare genetic disorder, Fabry disease

FDA Approvals

The U.S. FDA approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease. The drug is indicated for adults...

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