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January 04, 2023

US approval tracker: December 2022

December 30, 2022

Regulatory developments over the Christmas period

The FDA and Biogen come in for fierce Congressional criticism, and a handful of new cancer drugs are approved in Japan.

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November 30, 2022

Go or no go? Mirati heads to the FDA

TG Therapeutics and Gilead also await a verdict, and Cytokinetics is set for a panel.

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September 02, 2022

Brace for an end-of-year boost to drug approvals

The first half of 2022 was slow on the regulatory front, but plenty of big decisions remain for Bristol Myers Squibb, Apellis and others.

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May 04, 2022

US FDA approval tracker: April 2022

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April 22, 2022

What next for developers seeking to emulate Zydelig?

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April 19, 2022

The red flags keep coming with TG Therapeutics

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April 04, 2022

US FDA approval tracker: March 2022

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April 01, 2022

Go or no go? Bristol's first-in-class hopes

April should mark the approval of some of the biggest drugs of 2022, including Alnylam's vutrisiran, while TG will hope to be spared pain at the PI3K adcom.

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March 25, 2022

MEI suffers from the FDA’s brake on accelerated approvals

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February 25, 2022

Go or no go? Bristol’s Lag3 debut

March Pdufa dates are set for relatlimab as well as Akebia’s vadadustat, while Amylyx’s ALS drug heads for a panel.

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