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More Consistent Rare Disease Flexibility Needed: Attorneys

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Three Hyman, Phelps & McNamara attorneys call on FDA to be more consistently flexible in dealing with regulatory approvals of rare...

Lilly Sees Positive Data in TaltzZepbound Combo

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Eli Lilly says that combining its psoriasis biologic Taltz (ixekizumab) with obesity drug Zepbound (tirzepatide) led to significan...

FDA Accepts for Review Hansa Biopharma Imlifidase BLA

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FDA accepts for review the Hansa Biopharma BLA for imlifidase to be used in kidney transplantation.

GLP-1 Crackdown, OTC Push and Faster Ph.1 Timelines: Makary

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FDA commissioner Marty Makary says the agency will step up enforcement against unlawful mass compounding of GLP-1 weight-loss drug...

Rare Disease Innovation Hub 2026 Strategic Agenda

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The FDA Rare Disease Innovation Hub sets eight action items for 2026.

BMS Files NDA for Multiple Myeloma

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FDA accepts for priority review a Bristol Myers Squibb NDA for iberdomide in combination with daratumumab and dexamethasone for pa...

Debate Intensifies Over Politicization of mRNA Vaccines

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FDAs refusal to review Modernas mRNA influenza vaccine reignites concerns that vaccine policy particularly involving mRNA technol...

FDA Warns Elanco Animal Health About Pradalex Ads

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The Center for Veterinary Medicine warns Elanco Animal Health about false and misleading claims in promotional materials for its P...

CGMP Issues at Australias Cosmetic Manufacturers Pty

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FDA warns Australias Cosmetics Manufacturers about CGMP violations in its production of drugs as a contract manufacturer.

Compass Pathways Reports 2nd Positive Trial for Depression Drug

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Compass Pathways reports that its investigational psilocybin therapy met the primary endpoint in a second pivotal Phase 3 trial fo...