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Following discussions with the FDA, it was decided that the NDA resubmission would seek accelerated approval for elamirpretide on the basis of improvement in knee extensor muscle strength.
The drug, Dawnzera, is approved to prevent symptoms of a rare genetic disease called hereditary angioedema (HAE) in adults ...
Attorney General Kris Mayes wants the U.S. Food and Drug Administration to remove restrictions on one of two drugs used in non-surgical abortions.
Ionis Pharmaceuticals won FDA approval for a drug that prevents painful swelling attacks triggered by a rare genetic ...
In 2024, Hurricane Helene triggered a nationwide shortage of the country's intravenous (IV) fluids after damaging a facility ...
Ionis on Thursday said the FDA green light covers Dawnzera for prophylaxis to prevent attacks of hereditary angioedema in patients 12 years of age and older and makes the drug is the first and only ...
Dawnzera is the third medicine cleared by U.S. regulators this year for the rare genetic condition, and the second wholly owned medicine Ionis has brought to market.
The Food and Drug Administration is cautioning consumers against eating select packages of Great Value raw frozen shrimp sold ...
A series of panels convened by the Food and Drug Administration is raising concerns that the agency is skirting federal rules and promoting fringe views about antidepressants and other products ...
The recalled frozen shrimp were sent to 13 different states and were shipped into the country through four different ports.
Abortion pills are safe, FDA-approved, and accessible by mail in Florida. The first two assertions are correct. The third runs up against the plain text of Florida law and puts the provider and the ...
The FDA has recalled Walmart's Great Value frozen raw shrimp after possible contamination with a radioactive isotope. Here’s ...
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