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- FDA CBER director overrides review team to grant accelerated approval for Replimune's melanoma therapy TudriqevA senior official at the FDA's Center for Biologics Evaluation and Research stepped in to reverse a prior rejection by the agency's review panel. The director of the office of clinical evaluation a…
- Medline expands recall of reprocessed electrophysiology and ultrasound catheters due to contamination riskMedline Industries has issued an expanded recall that adds new lots of reprocessed electrophysiology and ultrasound catheters after the FDA identified possible residual particulates in the devices.…