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On Monday, Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) released topline results from the Phase 3 PALISADE study of plozasiran in patients with genetically confirmed or clinically diagnosed ...
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
Inclisiran was approved for use in the European Union in December 2020. [7] In August 2021, it received NICE approval for use by the National Health Service in the UK. [11] In December 2021, it was approved for medical use in the United States. [6] [9] [12] The U.S. Food and Drug Administration considers it to be a first-in-class medication. [13]
Ulotaront (INN Tooltip International Nonproprietary Name; [1] developmental codes SEP-363856, SEP-856) is an investigational antipsychotic that is undergoing clinical trials for the treatment of schizophrenia and Parkinson's disease psychosis.
The U.S. Food and Drug Administration (FDA) approved the drug for use in acute pain, but Vertex aims to eventually win approval in chronic pain, too. Clinical trials are ongoing, ...
The drug, suzetrigine, received the FDA's official stamp of approval Thursday to be sold as a 50-milligram prescription pill taken every 12 hours, according to a press release.
In April 2016, Nuplazid (pimavanserin) was approved by the FDA for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. [ 20 ] [ 21 ] The non-binding advisory panel recommendation of 12-to-2 in support of approval that preceded the FDA approval action noted that the drug met an important need, despite its ...
(Reuters) -The U.S. Food and Drug Administration has granted approval to a treatment from Verona Pharma for a chronic lung disease that commonly affects smokers, the U.K.-based company said on ...