Drugs

Olympia Pharmaceuticals Hit With 483 Over Sterile Manufacturing

FDA has cited Olympia Pharmaceuticals for eight observations involving aseptic processing, environmental monitoring, component testing and other manufacturing controls following an inspection last month at the company's Orlando, FL, outsourcing facility.

The Form 483 said Olympia’s aseptic processing areas had deficiencies in environmental and personnel monitoring. Investigators observed sterile filling-line processes taking place without concurrent environmental or personnel monitoring.

FDA also said the company had not adequately established/followed procedures designed to prevent microbiological contamination of sterile drugs. Among other findings, investigators questioned whether sterilized filling-machine components remained sterile during storage and found deficiencies in smoke studies intended to demonstrate appropriate airflow during aseptic operations.

Additionally, investigators cited discrepancies between written procedures and actual manufacturing practices, deficiencies in qualification of employees conducting visual inspections of injectable products and shortcomings in the stability program for Sermorelin Acetate injection.

FDA Unveils Transparency Roadmap — Plans More Disclosures

FDA has unveiled a new Transparency Roadmap that calls for expanded public disclosure of complete response letters, clinical study reports, inspection records and other regulatory information as part of a broader fiscal year 2027 transparency initiative. The roadmap builds on FDA’s 2025 initiative to publicly release complete response letters

FDA Grants Fast Track Status to Trethera’s Lung Cancer Drug

The FDA has granted fast track status to Trethera’s TRE-515 in combination with KRAS inhibitors for certain patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). The designation covers TRE-515 combined with KRAS inhibitors for patients with G12C mutation-positive NSCLC previously treated with an

FDA Urged to Clarify Rare Disease Approval Pathways

FDA’s new commissioner, once confirmed and sworn in, should provide greater clarity on regulatory pathways for rare disease therapies, especially the use of single-arm clinical trials, a rare disease advocate argued in a new Washington Examiner commentary. David Gusick said uncertainty over FDA’s expectations could delay development

FDA Flags Evolus Instagram Promotion for Jeuveau

FDA’s Office of Prescription Drug Promotion (OPDP) has cited Evolus over an Instagram promotion for wrinkle treatment Jeuveau (prabotulinumtoxinA-xvfs), saying the post exaggerated the drug's effectiveness and onset of action while minimizing serious risks. OPDP noted that it had raised similar concerns with Evolus in 2019

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FDA Unveils Transparency Roadmap — Plans More Disclosures

FDA Grants Fast Track Status to Trethera’s Lung Cancer Drug

FDA Urged to Clarify Rare Disease Approval Pathways

FDA Flags Evolus Instagram Promotion for Jeuveau