The U.S. Food and Drug Administration has approved the first generic of Restasis (cyclosporine ophthalmic emulsion) 0.05% single-use vials (eye drops) to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (commonly known as dry eye). Increased tearContinue Reading
After the Department of Veterans Affairs sent an email to all employees mandating that all its health care personnel receive the COVID-19 shots, the Department of Justice (DOJ) issued an absurd Memorandum Opinion (memo) that completely ignores the law. NOTE: FDA EMERGENCY USE AUTHORIZATION FDA must ensure that recipients of the vaccineContinue Reading
On Monday, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injectionContinue Reading
On Monday, the U.S. Food and Drug Administration (FDA) approved Aduhelm (aducanumab) for the treatment of Alzheimer’s disease. Aduhelm was approved using the accelerated approval pathway, the FDA noted, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.Continue Reading
The U.S. Food and Drug Administration authorized marketing of a new prescription only device intended to reduce snoring and mild obstructive sleep apnea. Unlike devices used while patients sleep, this is the first device used while awake that is intended to improve tongue muscle function, which in time can helpContinue Reading
By Teddy Cambosa The Food and Drug Administration has approved the use of the generic form of glucagon for treating severe hypoglycemia. According to their online statement, FDA notes that the generic glucagon must be administered in an injection USP 1, 1mg vial packed in an emergency kit. Furthermore, theContinue Reading
On Friday, the US Food and Drug Administration (FDA) approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. “Today’s approval marks the first oral drug in this class and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a healthContinue Reading
