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Regeneron Phase 3 Fianlimab Combination Misses Primary PFS Endpoint in First-Line Metastatic Melanoma
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FDA Warns Against Use of Expired Amazon Basic Care Levonorgestrel 1.5 mg Across Multiple Lots

Pharma Now Editorial Team

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Regeneron Phase 3 Fianlimab Combination Misses Primary PFS Endpoint in First-Line Metastatic Melanoma

Regeneron's Phase 3 fianlimab-cemiplimab trial misses PFS significance vs. pembrolizumab, prompting manufacturing and pipeline reassessment.

Pharma Now Editorial Team

Pharma Now

FDA Warns Against Use of Expired Amazon Basic Care Levonorgestrel 1.5 mg Across Multiple Lots

FDA flags multiple Amazon Basic Care levonorgestrel 1.5 mg lots delivered past expiration, raising distributor oversight and expiry control concerns.

Pharma Now Editorial Team

Pharma Now

GSK Secures Updated FDA Approval Letter for TWINRIX Combination Hepatitis Vaccine in May 2026

FDA issues a May 2026 approval letter for GSK's TWINRIX, continuing a documented post-approval supplement cycle for the combination hepatitis vaccine.

Pharma Now Editorial Team

Pharma Now

GlaxoSmithKline Biologicals Gains FDA Approval Action on BOOSTRIX in May 2026

FDA issued a May 14, 2026 approval letter for GSK Biologicals' BOOSTRIX Tdap vaccine, continuing a multi-year supplemental BLA activity pattern.

Pharma Now Editorial Team

Pharma Now