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FDA awards Boehringer Ingelheim Pharmaceuticals an accelerated approval for Hernexeos (zongertinib) for certain adults with unrese...[ Price : $8.95]
FDA prepares to roll out a new bonus program that will reward drug and biologic reviewers for completing high-quality reviews ahea...[ Price : $8.95]
An FDA Voices post by FDA chief operating officer Barclay Butler says the agencys ability to uphold the gold standard of regulator...[ Price : $8.95]
A rare disease advocacy group tells Congress to increase FDA oversight, warning that inconsistent use of regulatory flexibility an...[ Price : $8.95]
FDA approves a Sanofi and Regeneron Pharmaceuticals BLA supplement for Dupixent (dupilumab) and its use for treating adults and ch...[ Price : $8.95]
FDA issues an early alert about a potentially high-risk problem involving certain heart pump components manufactured by Abiomed, w...[ Price : $8.95]
CDER Division of Applied Regulatory Science (DARS) has published its 2025 Annual Report, highlighting significant research advance...[ Price : $8.95]
Rep. Josh Gottheimer introduces several bills to mark Rare Disease Week.