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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 […]
December 20, 2022

FDA Calls for Withdrawal of Multiple Myeloma Drug Pepaxto FDA Calls for Withdrawal of Multiple Myeloma Drug Pepaxto

The US Food and Drug Administration (FDA) has requested that Oncopeptides AB withdraw the US marketing authorization for its multiple myeloma drug Pepaxto (melphalan flufenamide), the […]
December 19, 2022

FDA Expands Approval of Imaging Agent Cytalux for Lung Cancer FDA Expands Approval of Imaging Agent Cytalux for Lung Cancer

The US Food and Drug Administration (FDA) has approved pafolacianine (Cytalux) for use as an injectable imaging agent for adults with lung cancer. The new approval, […]
December 16, 2022

FDA Approves First Gene Therapy for Bladder Cancer FDA Approves First Gene Therapy for Bladder Cancer

The US Food and Drug Administration has approved nadofaragene firadenovec-vncg (Adstiladrin), the first gene therapy for adults with bladder cancer. The adenovirus vector based gene therapy […]
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