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Latest From Sanofi

Keeping Track: Recarbrio Approval Highlights Two-Week Roundup

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

US FDA Performance Tracker Approvals

Insulin Application Reviews Would Continue After March 2020 Under Senate Bill

Bill would change US FDA's approach to handling follow-on applications submitted under Section 505 once products become "deemed" as biologics 23 March 2020, and could amend a provision in the Senate HELP Committee's health care bill, which aligns with FDA policy.

Biosimilars Biologics

US FDA, Advisory Committees Rarely Disagree

A Milbank Quarterly study and a Pink Sheet analysis show that disagreement between the US FDA and its advisory committee meetings doesn't happen often; it is even rarer for the agency to approve a drug against the advice from a panel.
Advisory Committees Approvals

AstraZeneca’s Farxiga Fails To Get FDA OK As Insulin Supplement In Type 1 Diabetes

The UK pharma said the FDA had issued a complete response letter, declining its application for using Farxiga in the new T1D indication. Analysts suspect worries over diabetic ketoacidosis risk lie behind the rejection.

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