Ketorolac Tromethamine is indicated for the short-term (more than or equal to 5 days) management of moderately severe acute pain in adult patients
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In a late-stage study, the antibody-based drug, otilimab, did not make a meaningful difference to improving swelling and tenderness in joints to aid movement in patients who had not responded to other forms of treatment before
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The meeting, scheduled for Nov. 18, was delayed to review additional information, and no new date has yet been set, in a setback for what was expected to be the first approved daily OTC birth control pill in the United States
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Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary.
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Biogen said it had submitted responses to the FDA's information requests, which the agency said would require additional time for review and set a new target action date of April 25, 2023
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Danco, one of two U.S. companies that make the medicine, said that right now it has no plans to do so."At this time, we are not planning to submit (an application) for miscarriage management, but may reconsider in the future," a spokesperson said
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As a part of the regulation for CE certification, the EU MDR accreditation is mandatory for sales to European countries and several other regulated markets. The purpose of the regulation is to ensure that manufacturers produce safe products, meeting global safety standards, the statement said
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ALS, also known as Lou Gehrig's disease, breaks down nerve cells in the brain and spinal cord that make muscles work, leading to progressive paralysis and death. It affects more than 30,000 patients in the United States, according to the patient advocacy group ALS Association.
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