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Q BioMed’s Uttroside-B Receives U.S. FDA Orphan Drug Designation in the Treatment of Liver Cancer

The Pharma Data

billion by 2027. is a biotech acceleration and commercial stage company focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. An estimated 700,000 people are diagnosed with HCC each year, with the global market for liver cancer drugs expected to grow to $3.9 About Q BioMed Inc.

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Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Agency IQ

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

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Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

CDER, CBER 9/30/2027 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Digital Health Technologies Publish draft guidance describing a process to evaluate a predetermined change control plan for digital health devices. Priority B List. primary and secondary).

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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

RE47,739 for Ibrance by more than four years until March 2027. 7) BNT162b2 has not been approved or licensed by the U.S. In February 2021, Pfizer announced that the U.S. Patent and Trade Office issued a U.S. Patent Term Extension certificate extending the term of U.S. If approved, TicoVac would be the first vaccine in the U.S.

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Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

October 1, 2023 [link] Regulations Expected to be Published in Q3These are taken from the most recent version of the White House’s Unified Agenda. Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.

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Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

FDA Law Blog: Biosimilars

A state-regulated cannabis industry better protects consumers than the illicit market or the unregulated intoxicating hemp-derived marketplace. Demand for cannabis products will continue, and meeting that demand only in a regulated, legal marketplace better protects consumers. January 29, 2024).