May 21, 2024
The US Food and Drug Administration (FDA) has announced the withdrawal of its 2021 accelerated approval of infigratinib (Truseltiq) for patients with a certain type of […]
May 16, 2024
The US Food and Drug Administration has granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen) for extensive-stage small cell lung cancer (SCLC) with disease progression on or […]
May 16, 2024
The US Food and Drug Administration has granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics /Bristol Myers Squibb) for adults with relapsed or refractory follicular […]
May 8, 2024
The US Food and Drug Administration (FDA) has announced that Tandem Diabetes Care, Inc has issued a recall regarding version 2.7 of the Apple iOS t:connect […]
May 7, 2024
The US Food and Drug Administration (FDA) has approved ColoSense (Geneoscopy, Inc), a multitarget stool RNA (mt-sRNA) test for colorectal cancer (CRC) screening in adults aged […]
May 2, 2024
The US Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of adalimumab-adbm (Cyltezo), a biosimilar of Humira, Boehringer Ingelheim announced. This high-concentration formulation […]
April 26, 2024
The US Food and Drug Administration (FDA) has approved a new treatment for uncomplicated urinary tract infections (UTIs). The agency on April 24 approved pivmecillinam tablets […]
April 26, 2024
The European Medicines Agency (EMA) this week recommended granting a marketing authorization for Altuvoct (efanesoctocog alfa) for the treatment and prophylaxis of bleeding in patients with hemophilia […]
April 26, 2024
A marketing authorization should be given for the medicinal product Obgemsa (vibegron) for treating adults with overactive bladder (OAB) syndrome, the European Medicines Agency (EMA) has […]