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Drug Approvals

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Latest From Approvals

Keeping Track: Zelboraf Takes Breakthrough Path For Rare Blood Disease; Teva Resubmits Generic EpiPen

The latest drug development news and highlights from our US FDA Performance Tracker.

Performance Tracker Approvals

FDA's NDA And BLA Approvals: Qvar, Carospir, Nikita

Original new drugs and biologics recently approved by US FDA.

Approvals Regulation

US FDA's Search For Meaning: Interpretation Of Regulatory Language Can Inspire Conflict In Drug Reviews

The Pink Sheet's Drug Review Profile series illustrates the challenge of reconciling review realities and broad statutory directives.

Drug Review Profile Review Pathway

FDA's Generic Approvals Catch A Bit Of Breath In July But Continue At Fast Pace

US Generic drug approvals drop in July, but still are above the monthly average for the year, potentially signaling a new expected output.

FDA Generic Drugs

Keeping Track: US FDA Approvals Of Mavyret, Idhifa, Vyxeos Headline Week Of Breakthroughs, Hematology And Hematology BTDs

The latest drug development news and highlights from our FDA Performance Tracker.

Approvals Biosimilars

Don't Lose Track: Review And Approval News On Opdivo, Kalydeco And More

US FDA had a busy week. Here's some bullet points of product development events you may have missed.

Approvals Drug Review
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