Semaglutide was approved in 2019 by the FDA to treat Type 2 diabetes, sold under the brand name Ozempic, albeit at a lower dose. At the higher dose of 2.4 mg, the drug acts on centers in the brain to reduce appetite, leading to potentially significant weight loss when combined wit...
Two new longer-acting versions of amantadine have been approved by the FDA: amantadine ER and amantadine HCl tablets (the latter combining both IR and ER forms). The potential benefit of a longer duration of action has been suggested to reduce higher nocturnal levels of drug that may trigger ...
Nearly one third of drugs newly approved by the US Food and Drug Administration (FDA) are affected by safety issues that were not known at the time of approval, a study has shown. Biologic and psychiatric drugs, as well as those that received accelerated approval or were approved within 60 ...
There are few pharmaceutical treatments forCryptosporidiuminfection. The only medication that the Food and Drug Administration has approved is NTZ6. NTZ reduces oocyst shedding and treats diarrhoea for 3–4 days7. Results in HIV-infected individuals are not encouraging, and there is marked debate on...
The FDA has set a Prescription Drug User Fee Act, or target action, date of January 20, 2024. The results are also being discussed with regulatory authorities worldwide. In the U.S., KEYTRUDA has two approved i...
KEYTRUDA, as a single agent, is indicated for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following p...
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Our study approaches the ALA formulation by assessing the preformulation parame- ters, the critical quality attributes in order to obtain a FSP with a dissolution profile similar to the reference listed drug (RLD) according to the USP. US FDA Guidance describes the model-independent mathematical ...
Andexanet alpha is FDA approved for treatment of life threating and uncontrolled bleeding episodes with rivaroxaban, but it is associated with adverse effects such as deep vein thrombosis, pulmonary embolism, myocardial infarction, and ischemic stroke [16]. Drug-drug interactions of rivaroxaban are ...