News

Eagle-Tribune16d
US Food and Drug Administration (FDA) Grants Interchangeability Designation to Samsung Bioepis and Organon HADLIMA™ (adalimumab-bwwd) Injection
Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration ...
Eagle-Tribune16d
Savara Receives Refusal to File (RTF) Letter From the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for MOLBREEVI* to Treat Patients With ...
Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced that the Company received an RTF letter from the FDA for ...
Medical Xpress1mon
Drug to slow Alzheimer's well tolerated outside of clinical trial setting, study finds
The Food and Drug Administration's approval in 2023 of lecanemab—a novel Alzheimer's therapy shown in clinical trials to modestly slow disease progression—was met with enthusiasm by many in ...
TechCrunch1mon
OpenAI and the FDA are reportedly discussing AI for drug evaluations
OpenAI has met with officials from the U.S. Food and Drug Administration (FDA) to discuss the agency’s use of AI to speed up drug evaluations, Wired reported on Wednesday. According to the ...
Wired1mon
OpenAI and the FDA Are Holding Talks About Using AI In Drug Evaluation
The Food and Drug Administration has been meeting with OpenAI to discuss the agency’s use of AI, according to sources with knowledge of the meetings. The meetings appear to be part of a broader ...
The New England Journal of Medicine1mon
Chemical Complexity of Food and Implications for Therapeutics
costly safety trials required for approval by the Food and Drug Administration. Furthermore, knowledge of the targets of NDM molecules with validated mechanisms of action can help identify ...
UPI1mon
FDA to boost surprise inspections at foreign-based food, medical plants
May 6 (UPI) --The U.S. Food and Drug Administration said Tuesday it will ... that produce items such as food products or essential "medical products." Unannounced inspections, according to the ...
Benzinga.com1mon
FDA Expands Surprise Inspections At Foreign Drug And Food Facilities, Targets Double Standards In Overseas Manufacturing Oversight
The U.S. Food and Drug Administration (FDA ... essential medicines, and other medical products intended for American consumers and patients. This change builds upon the agency’s Office of ...
KEYT1mon
Nipomo Woman Pleads Guilty to Faking Medical Immigration Forms and Drug Trafficking
LOS ANGELES – Chantelle Lavergne Woods pleaded guilty Monday to misusing the identities of medical professionals ... Woods used the Drug Enforcement Administration registration number of a ...
Morningstar1mon
Genmab to Submit Supplemental Biologics License Application (sBLA) to U.S. Food and Drug Administration for Epcoritamab Plus Rituximab and Lenalidomide (R2) in Patients with ...
Decision to submit based on a positive overall response rate (ORR) (p-value < 0.0001), one of the dual primary endpoints in the Phase 3 EPCORE® FL-1 trial ... the U.S. Food and Drug ...
Acsh.org1mon
FDA in Crisis: How Trump Administration Downsizing Is Slowing Medical Innovation and Endangering Public Health
Gutted by Administration-initiated layoffs and seemingly ideologically-motivated cuts, the agency tasked with keeping your food safe and ... librarians who secured medical and scientific journal ...