They are made by licensed pharmacies, but not approved or inspected by the FDA. Drug compounding is allowed when drugs are on the FDA's shortage list, or in circumstances when a patient can't take ...
In the AAL, the FDA determined this is a minor amendment, meets the criteria for priority review, and assigned an approval goal date of June 4, 2025. Fabio Chianelli, Chairman and CEO of PharmaThe ...
In the AAL, the FDA determined this is a minor amendment, meets the criteria for priority review, and assigned an approval goal date of June 4. As announced on March 3, PharmaTher provided its ...
Upcoming market catalysts for the second quarter of 2025 include the US approval decisions for clesrovimab (MK-1654) for respiratory syncytial virus (RSV) prophylaxis, sebetralstat for hereditary ...
FDA inspectors have oversight over nearly 300,000 ... But the process for getting charges approved is confusing, the criteria for what counts as an emergency keeps changing, and each request ...
“Making these chemicals immediately illegal until obtaining FDA approval may cause disruptions in the food supply. Ensuring that existing GRAS chemicals are safe to remain in our foods should be ...
The FDA is reviewing the supplemental NDA for cabozantinib in ... absorption and robust efficacy compared with existing DHE products. The Company is seeking approval for acute treatment of migraine ...
The safety communication lists the brands that should not be used, details the FDA's actions, and provides recommendations for consumers. Ultraviolet-C radiation is a type of radiation.
When the FDA formally approves substances for use in food, it can let decades pass without reassessing them — even when subsequent research raises doubts about their safety. In January ...
Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The U.S. Food and Drug ...
Venus Remedies announced on Tuesday that it has received marketing authorization from the Philippines for a medication used to ... agent (SRBA), is Venus Remedies' first global marketing approval. The ...
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