May 16, 2019
Comments Off on Federal judge orders FDA to speed up its review of e-cigarettes
WASHINGTON — A federal judge is siding with public health groups suing the Food and Drug Administration to begin reviewing thousands of e-cigarettes on the U.S. market. The ruling handed down Wednesday in district court states that the agency shirked ...
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September 5, 2018
Comments Off on Maryland biopharm gets orphan drug designation
Antidote Therapeutics Inc., a biopharmaceutical company based in Gaithersburg, has received a special designation for its drug under development.
Tagged with: Antidote Therapeutics Inc. FDA gaithersburg Montgomery County orphan drug
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August 14, 2015
Comments Off on Execs behind female sex drive pill have run afoul of FDA
WASHINGTON — A small drugmaker from North Carolina may succeed next week where many of the world’s largest pharmaceutical companies have failed: in winning approval for the first drug to boost women’s sexual desire. The husband-and-wife team that founded Sprout ...
Tagged with: FDA
Read More »Federal health officials on Friday approved the first lower-cost copy of a biotech drug in the U.S., a long-awaited milestone that could save billions for insurers, doctors and patients.
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The Food and Drug Administration is warning doctors against over-prescribing testosterone-boosting drugs for men, saying the popular treatments have not been established as safe or effective for common age-related issues like low libido and fatigue.
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February 20, 2015
Comments Off on FDA OKs varicose vein treatment
The Food and Drug Administration has approved a new technique for treating varicose veins by sealing them with a clear liquid that turns into a solid adhesive. The VenaSeal system is approved for patients with varicose veins of the legs ...
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Read More »The Food and Drug Administration approved 41 first-of-a-kind drugs in 2014, including a record number of medicines for rare diseases, pushing the agency's annual tally of drug approvals to its highest level in 18 years.
Tagged with: FDA food and drug administration health insurance medicine
Read More »Clear Guide Medical, a medical technology company that is a Johns Hopkins University spin-off, announced on Friday that its first clinical product, the Clear Guide One, has been approved by the Food and Drug Administration. Clear Guide One uses an ...
Read More »The Supreme Court on Thursday sided with juice maker Pom Wonderful in its long-running false advertising dispute with Coca Cola, a decision that could open the door to more litigation against food makers for deceptive labeling.
Tagged with: Coca Cola coke FDA lawsuit legal news
Read More »Ice cream lovers beware: The government knows you're unlikely to stop after half a cup.
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