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The FDA revised its emergency authorization of Regeneron’s antibody cocktail, REGEN-COV (casirivimab/imdevimab), to include its use for prevention of COVID-19 infection in individuals 12 years and older who have been exposed to the coronavirus and are at high risk of progressing to severe disease. Read More
The FDA has approved the first-ever interchangeable biosimilar insulin product, which could signal the beginning of the end for the soaring costs of insulin products. Read More
Merck’s cancer immunotherapy Keytruda (pembrolizumab) has become the first drug of its kind to be approved for early triple-negative breast cancer after a previous rejection from the FDA for the indication in March due to lack of data. Read More
Patients who want to start treatment with Biogen’s newly approved Alzheimer’s drug, Aduhelm (aducanumab), should undergo cognitive testing, brain imaging to exclude cerebrovascular disease and have either a lumbar puncture or PET scan to confirm the presence of cerebral amyloid, a new set of treatment recommendations advises. Read More
Bydureon BCise is part of a diabetes drug class known as glucagon-like peptide-1 agonists, which boost insulin levels in the body when blood sugar levels are elevated. Read More
The European Medicines Agency’s (EMA) human medicines committee recommended two new drugs for approval at its monthly meeting last week, including a Sanofi biologic for a rare disorder and a generic of Novartis’ oncology drug Glivac (imatinib). Read More
The FDA has granted full approval for Merck’s blockbuster cancer drug Keytruda (pembrolizumab) in combination with Merck and Eisai’s tyrosine kinase inhibitor Lenvima (lenvatinib) for treating advanced endometrial carcinoma. Read More
Sanofi and nonprofit partners in Africa have won FDA approval for the first oral treatment for sleeping sickness. In addition to the approval, the FDA granted the partners a priority review voucher (PRV) worth millions of dollars. Read More