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Daiichi Sankyo, Merck Lung Cancer Therapy Gets Priority Review

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FDA accepts for priority review a Daiichi Sankyo and Merck BLA for ifinatamab deruxtecan, an investigational therapy for patients ...

Pfizers Adcetris Social Media Ads are Misleading: FDA

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FDA cites Pfizer over social media promotions for its cancer drug Adcetris, stating that certain Facebook advertisements are false...

Cato Institute urges FDA overhaul to keep pace with AI

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A new policy analysis from the Cato Institute urges FDA to modernize its regulatory framework for artificial intelligence in healt...

Telix NDA Resubmission for Brain Cancer Imaging Agent

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FDA accepts a Telix Pharmaceuticals resubmitted NDA for TLX101-Px, an investigational PET imaging agent for glioma.

FDA Cites Manufacturing, Quality Lapses at Orchid Pharma

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FDA cites significant manufacturing and quality control deficiencies at an active pharmaceutical ingredient facility operated by O...

FDA rejects Replimune Melanoma Therapy Again

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FDA issues Replimune another complete response letter, declining to approve its BLA for vusolimogene oderparepvec in combination w...

Alert on Cook Medical Sizing Catheters

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FDA issues an early alert regarding a potential safety issue affecting certain sizing catheters manufactured by Cook Medical.

Rep. Auchincloss Seeks FDA Whistleblowers

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Representative Jake Auchincloss (D-MA) urges FDA whistleblowers to come forward to disclose instances of wrongdoing by agency mana...

Will the Push for DTC Pre-Review Grow?

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Two Hyman, Phelps & McNamara attorneys describe the impacts on industry if FDA responds to a congressional push for more pre-revie...

RFK Jr. Tones Down Vaccine Skepticism in Run Up to Midterms

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HHS secretary Robert F. Kennedy Jr. curtails his public commentary on vaccines as part of a deliberate political strategy by the T...