At its May 30 meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) endorsed the approval of several cancer […]
The Committee for Medicinal Products for Human Use (CHMP) has recommended dropping a previous ban on donations of blood or plasma for fractionation from individuals who […]
In its May 2024 meeting, the European Medicines Agency (EMA) gave the go-ahead for Durveqtix to treat severe and moderately severe hemophilia B in adults who […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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