… Citizen Petition with the US Food and Drug Administration (FDA), seeking the removal of Benzethonium … manufacture, while it awaits generic approval. The Company is additionally seeking … file an NDA for Accelerated Approval for NRX-101 in patients …

… that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug ( … into clinical development. This IND approval reflects Innovent's strong … (NMPA) and approved by the U.S. Food and Drug Administration (FDA). A multi-regional …

The U.S. Food and Drug Administration (FDA) has approved an investigational new drug application … newsletters here. References “Anbogen Receives FDA Clearance to Initiate Phase 1 …

… Secured: Anbogen Therapeutics receives FDA approval to start Phase I … development and commercialization. The FDA has granted Anbogen Therapeutics … 1 References Anbogen Receives FDA Clearance to Initiate … /anbogen-receives-fda-clearance-to-initiate-phase …

… need to modernize our approval processes and post-market … , as there are no FDA-approved 7-OH drugs.1 In … threatening American consumers. News release. FDA. July 29, 2025. Accessed … products-threatening-american-consumers 3. FDA. 7-hydroxymitragynine (7-OH): …

Anbogen Therapeutics has received US FDA approval for its investigational new drug ( … in mCRC. With the FDA's IND approval, Anbogen Therapeutics is … -301. REFERENCES: 1. Anbogen Receives FDA Clearance to Initiate Phase 1 …

… the first country to approve PYRUKYND for the treatment … . Food and Drug Administration is September 7, 2025. PYRUKYND is also approved for … Agios’ expectations for the FDA’s review of its sNDA … and maintain requisite regulatory approvals and to enroll patients …

… the company announced that the Food and Drug Administration (FDA) had rejected its application for … Therapy designation by the FDA, its Accelerated Approval pathway, and assurances … approve the application in its present form." More critically, the FDA …

… Key Takeaways: FDA-mandated label changes: The FDA is requiring … need to modernize our approval processes and post-market … for OxyContin was initially approved without study data supporting … data from two large FDA-required observational studies, called …

… needs to be done," FDA Commissioner Marty Makary, M. … press release, adding that drug approval and post-market monitoring processes … epidemic. Required labeling updates The FDA's opioid safety … use. Industry impact The FDA says it has sent letters …