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Food and Drug Administration--Press Releases
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Last updated about 6 hours ago
FDA Roundup: September 27, 2024
about 6 hours ago
The U.S. Food and Drug Administration is providing an at-a-glance summary of...
FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia
1 day ago
FDA approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for...
FDA Approves New Drug to Treat Niemann-Pick Disease, Type C
3 days ago
FDA approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with...
FDA Roundup: September 24, 2024
3 days ago
The U.S. Food and Drug Administration is providing an at-a-glance summary of...
FDA Roundup: September 20, 2024
7 days ago
The U.S. Food and Drug Administration is providing an at-a-glance summary of...
FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration
7 days ago
FDA approves FluMist for self- or caregiver-administration. FluMist is approved for use...
FDA Approves First Treatment for Niemann-Pick Disease, Type C
8 days ago
The FDA approved Miplyffa (arimoclomol), an oral medication for the treatment of...
FDA Roundup: September 17, 2024
10 days ago
The U.S. Food and Drug Administration is providing an at-a-glance summary of...
FDA Issues Draft Guidance on Conducting Multiregional Clinical Trials in Oncology
12 days ago
The FDA issued a draft guidance that, when finalized, will provide sponsors...
FDA Roundup: September 13, 2024
14 days ago
The U.S. Food and Drug Administration is providing an at-a-glance summary of...
FDA Authorizes First Over-the-Counter Hearing Aid Software
15 days ago
The FDA authorized the first over-the-counter hearing aid software device, Hearing Aid...
FDA Issues Warning Letters to Two Chinese Firms Regarding Data Quality and Integrity Concerns, Violative Lab Practices
16 days ago
FDA issued warning letters to two Chinese nonclinical testing laboratories, citing both...