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Roberts Laboratories Inc.

Latest From Roberts Laboratories Inc.

End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timeframes

Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year. 

Pink Sheet Perspectives US FDA Performance Tracker

Pfizer In Pole Position To Benefit From Novartis Sickle Cell Drug Setback

Pfizer joined Novartis as the market leader in sickle cell disease when it acquired Global Blood Therapeutics last year. The US giant's Oxbryta may now move ahead following a clinical and regulatory setback for the Swiss major's Adakveo.

Blood & Coagulation Disorders Drug Review

Ophthalmic Bevacizumab & CRISPR-Based Gene Therapy Among Latest EU Filings

Investigational drugs from Outlook Therapeutics and Vertex/CRISPR could become first-of-their-kind products if they win marketing approval.

Europe Drug Review

Keeping Track: Two Targeted Oncologics And A Novel SGLT-2 Inhibitor Clear US FDA

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Approvals Review Pathway
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