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May 28, 2024 · Kessler and David Raben, MD, professor of radiation oncology at the CU School of Medicine, started Rueda on hormone therapy, as well as a course of radiation therapy, followed by chemotherapy. The treatment worked so well that soon after it ended, Rueda, a longtime runner, was able to complete a half marathon and two full marathons.
May 17, 2024 · During the litigation, Bayer failed to exclude an expert for plaintiffs: former FDA commissioner Dr. David Kessler. Kessler, who served from 1990 to 1997, said Bayer withheld vital information about the risks associated with Yaz during the approval process.
5 days ago · A Food and Drug Administration advisory panel on Tuesday declined to recommend the approval of MDMA, commonly known as ecstasy or molly, as a treatment for post-traumatic stress disorder, a major...
6 days ago · SAN JOSE, Calif., June 4, 2024 /PRNewswire/ -- Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, announced the outcome of the U.S. Food and Drug Administration's ...
May 29, 2024 · The lawsuit challenges the Final Rule because FDA has exceeded its statutory authority and acted arbitrarily and capriciously in violation of the Administrative Procedure Act. “FDA’s Final Rule is the wrong approach, both as a matter of law and public policy, and represents regulatory overreach,” said ACLA President Susan Van Meter.
6 days ago · The role of PDAC is to provide the FDA with independent, expert advice and recommendations based on their review and evaluation of data concerning the safety and effectiveness of investigational medicines for use in the practice of psychiatry and related fields. 1 The FDA's approval decision is expected by the Prescription Drug User Fee Act ("PDUFA") target action date of August 11, 2024.
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1 day ago · The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the...
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