FDA

15 articles in the TruthFoundry index. Each links out to the original.

• FDA Issues Temporary Policies for Neonatal Parenteral Nutrition Compounding · FDA announces immediate implementation of temporary compounding policies for neonatal nutrition products due to market exit.
• FDA Releases 2026 Draft Guidance on Drug Development and Biosimilars · The FDA published a comprehensive list of new draft guidance documents covering drug development, biosimilars, and clinical trials in 2026.
• FDA Approves Multiple New Cancer Drugs in 2026 · The FDA granted accelerated or traditional approvals for several new therapies treating breast, pancreatic, lung, and prostate cancers.
• FDA Grants Accelerated Approval for Camizestrant in ESR1-Mutated Breast Cancer · FDA approved camizestrant plus CDK4/6 inhibitor for ESR1-mutated HR-positive, HER2-negative metastatic breast cancer.
• FDA Issues Public Notifications on Hidden Ingredients in Weight Loss Products · Regulatory bodies warn consumers that numerous weight loss supplements contain undisclosed pharmaceutical ingredients.
• FDA Warns Against ZUBB Supplement Containing Hidden Sildenafil · FDA advises consumers not to use ZUBB Dietary Supplement due to undisclosed sildenafil.
• EL-PFDD Hosts Condition-Specific Patient Listening Sessions and Meeting Reports · The EL-PFDD platform hosted numerous patient listening sessions and meetings covering rare diseases and medical conditions.
• FDA Lists Dates for Upcoming Externally-Led Patient-Focused Drug Development Meetings · The FDA publishes a schedule of upcoming Externally-Led PFDD meetings across various disease areas.
• FDA Reports GDUFA Type II API DMF Payment Receipts for 2023-2026 · The FDA published a report detailing monthly GDUFA Type II API DMF payment receipts from fiscal years 2023 through 2026.
• FDA Clears Dental Technologies Inc. Corrective Actions on 2021 Violations · FDA confirms Dental Technologies Inc. adequately addressed violations from a 2021 warning letter.
• FDA Releases Compressed Drugs@FDA Database Files for Public Use · The FDA provides a compressed data file containing 12 tables of the Drugs@FDA database for users to import into spreadsheets or databases.
• FDA Announces Multiple Rare Disease Drug Approvals in 2026 · The FDA approved several new treatments for rare diseases including Alexander disease and narcolepsy type 1 in 2026.
• FDA Approves 37 Novel Drugs for Cancer, Diabetes, and Rare Diseases in 2026 · The FDA approved 37 new drug treatments in 2026 for conditions including cancer, diabetes, and rare genetic disorders.
• FDA Extends Use Dates for Specific Drug Lots to Alleviate Shortages · FDA approves extended use dates for specific lots of bupivacaine and dextrose to address supply shortages.
• FDA Publishes 2027 Self-Identified Generic Drug Facility Lists · The FDA released the FY 2027 list of self-identified generic drug facilities, sites, and organizations.