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Cubist Pharmaceuticals, Inc.

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Latest From Cubist Pharmaceuticals, Inc.

Coronavirus Update: Gilead's Veklury Gets Full FDA Approval, Roche Partners With Atea

Gilead's remdesivir is first drug fully approved by FDA to treat COVID-19. Roche and Atea team up on an investigational direct acting antiviral while Moderna reaches the 30,000-patient enrollment target for its Phase III COVE study of the company's investigational mRNA vaccine. 

Coronavirus COVID-19 Vaccines

Legal Notebook: Catalyst’s Suit vs. FDA Is Tossed, Avonex Patent Invalidity Verdict Is Reinstated

Court finds US FDA did not impede Catalyst orphan exclusivity for Firdapse as it approved different indication for competing product. Biogen loses 10-year patent battle against competing multiple sclerosis drug makers.

FDA Intellectual Property

A Matter Of Precedent: US FDA Sometimes Labors Under Weight Of Unpopular Or Unfavorable Decisions

As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.

FDA Coronavirus COVID-19

FDA OKs Blueprint/Roche's Gavreto As Rival To Lilly's Retevmo

Regulators in the US have approved Gavreto for metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer, setting the stage for a head-to-head battle for market share with Eli Lilly's Retevmo.

Approvals Cancer
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