May 31, 2024
The European Medicines Agency (EMA) has recommended granting a marketing authorization in the European Union for Ixchiq (Valneva Austria), the first vaccine for EU countries intended […]
May 30, 2024
The US Food and Drug Administration (FDA) has approved Onyda XR (clonidine hydrochloride) for the treatment of attention-deficit/hyperactivity disorder (ADHD), drug manufacturer Tris Pharma announced in […]
May 21, 2024
The US Food and Drug Administration (FDA) has approved Benlysta (belimumab) autoinjector for patients aged 5 years or older with active systemic lupus erythematosus (SLE) on […]
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 […]