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Drug Approvals

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Latest From Approvals

Abuse-Deterrent Opioids: US FDA Follows The ‘Route Of Abuse’ To Exclusivity

Inspirion’s MorphaBond win suggests agency’s thinking on three-year exclusivity for abuse-deterrent formulations has ‘evolved’ from a formulation-specific approach to one based on route of abuse.

Policy Approvals

Keeping Track: US FDA Files Another Pfizer Cancer Biologic And TMC's New Antibiotic

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

Performance Tracker Approvals

FDA's NDA And BLA Approvals: Ganciclovir

Original new drugs and biologics recently approved by US FDA.

Approvals Regulation

FDA's ANDA Approvals

US generic drug approvals and tentative approvals for mid-February.

Approvals Regulation

Pfizer Warning Letter Trips Up Sandoz/Momenta’s Expected Glatopa Launch

Sandoz/Momenta’s generic of Teva’s 40 mg Copaxone appeared imminent – until apparently unrelated FDA warning letter regarding contract manufacturer Pfizer’s McPherson, Kan., plant put review on hold.

Manufacturing Quality

On Tap: Novel Agents Awaiting US FDA Action In 2017

New molecular entities and novel biologics on US FDA's user fee calendar for 2017.

Approvals Regulation
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