January 6, 2023
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
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 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
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
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
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
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
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
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 […]