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January 20, 2023

FDA OKs Zanubrutinib (Brukinsa) for CLL or SLL FDA OKs Zanubrutinib (Brukinsa) for CLL or SLL

The US Food and Drug Administration (FDA) granted accelerated approval for zanubrutinib (Brukinsa) to treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). […]
January 20, 2023

Tucatinib Plus Trastuzumab Approved for HER2+ CRC Tucatinib Plus Trastuzumab Approved for HER2+ CRC

A combination of HER2-targeted drugs used in breast cancer is now available for use in colorectal cancer. The US Food and Drug Administration (FDA) has granted […]
January 12, 2023

FDA OKs Tdap Shot in Pregnancy to Protect Newborns From Pertussis FDA OKs Tdap Shot in Pregnancy to Protect Newborns From Pertussis

The Food and Drug Administration has approved another Tdap vaccine option for use during pregnancy to protect newborns from whooping cough. The agency on Jan. 9 licensed Adacel […]
January 6, 2023

FDA Approves Second Anti-Amyloid for Alzheimer’s Disease FDA Approves Second Anti-Amyloid for Alzheimer’s Disease

The US Food and Drug Administration (FDA) has approved the anti-amyloid beta protofibril antibody lecanemab (Leqembi, Eisai) for the treatment of Alzheimer’s disease (AD). Like its […]
January 3, 2023

FDA Approves Wegovy (Semaglutide) for Obesity in Teens 12 and Up FDA Approves Wegovy (Semaglutide) for Obesity in Teens 12 and Up

The US Food and Drug Administration has approved semaglutide 2.4 mg (Wegovy), a once-weekly subcutaneous injection, for the additional indication of treating obesity in adolescents aged […]
December 28, 2022

Lupin Recalls Quinapril Tablets Due to Potential Carcinogen Lupin Recalls Quinapril Tablets Due to Potential Carcinogen

Lupin Pharmaceuticals is recalling four lots of quinapril tablets because of unacceptable levels of the nitrosamine impurity, N-nitroso-quinapril, a potential carcinogen. Nitrosamines “may increase the risk […]
December 23, 2022

FDA Approves First-in-Class Drug for Follicular Lymphoma FDA Approves First-in-Class Drug for Follicular Lymphoma

The US Food and Drug Administration has approved mosunetuzumab-axgb (Lunsumio) for use in patients with relapsed or refractory follicular lymphoma who have received at least two […]
December 22, 2022

FDA Approves First-in-Class Drug for HIV FDA Approves First-in-Class Drug for HIV

The US Food and Drug Administration (FDA) has approved the medication lenacapavir (Sunlenca) for adults living with multi-drug resistant HIV-1 infection. After the initial doses are […]
December 22, 2022

FDA Approves Abaloparatide (Tymlos) for Osteoporosis in Men FDA Approves Abaloparatide (Tymlos) for Osteoporosis in Men

The US Food and Drug Administration (FDA) has approved an additional indication for abaloparatide (Tymlos) to increase bone density in men with osteoporosis at high risk […]
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