FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa
- Details
- Category: FDA
The U.S. Food and Drug Administration has granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa's blood-thinning effects.
FDA approves new injectable drug to treat schizophrenia
- Details
- Category: FDA
The U.S. Food and Drug Administration approved Aristada (aripiprazole lauroxil) extended release injection to treat adults with schizophrenia. Aristada is administered by a health care professional every four to six weeks using an injection in the arm or buttocks.
FDA approves Keytruda for advanced non-small cell lung cancer
- Details
- Category: FDA
The U.S. Food and Drug Administration has granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1.
EMA's medical literature monitoring enters into full operation
- Details
- Category: EMA
The European Medicines Agency (EMA) has started its full medical literature monitoring service on 1 September 2015. A total of 400 active substance groups (300 chemical active substance groups and 100 herbal active substance groups) will now be monitored by EMA. The service will benefit over 4,000 companies.
FDA approves first treatment for sexual desire disorder
- Details
- Category: FDA
The U.S. Food and Drug Administration today approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi's approval, there were no FDA-approved treatments for sexual desire disorders in men or women.
FDA takes action to protect consumers from potentially dangerous counterfeit medicines and devices sold online
- Details
- Category: FDA
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 1,050 websites that illegally sell potentially dangerous, unapproved prescription medicines and medical devices to consumers.
FDA approves anti-clotting drug Savaysa
- Details
- Category: FDA
The U.S. Food and Drug Administration has approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
More Pharma News ...
- FDA warns consumers about fraudulent Ebola treatment products
- FDA issues guidance to support the responsible development of nanotechnology products
- FDA launches openFDA to provide easy access to valuable FDA public data
- FDA requires removal of certain restrictions on the diabetes drug Avandia
- EMA and US FDA release first conclusions of parallel assessment of quality-by-design applications
- FDA approves new drug to treat HIV infection
- FDA alerts companies to stop illegal sale of treatments for diabetes