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Product Reviews & Approvals

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Approvals

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Latest From Approvals

Zulresso Postmarket Commitment Hints At Easier Dosing In Postpartum Depression

US FDA wants Sage Therapeutics to explore Zulresso use in alternative settings in a postmarketing trial. A successful study could expand access to the new approved brexanolone, whose administration is now long, complicated, and restricted to certified healthcare facilities.
Approvals Neurology

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances now includes three new products including Lusutrombopag Shionogi for treating severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).

Europe Approvals

J&J’s Esketamine: A Model “Breakthrough” Program For US FDA

J&J’s treatment-resistant depression drug esketamine had an easy time at an FDA advisory committee despite raising some tough regulatory questions. If you are looking for a showcase of how “Breakthrough” drug development collaboration can help a new therapy get to patients faster, this might be it.

Review Pathway Approvals

Leaving On A High Note: US FDA Commissioner’s Departure Fits A Pattern

Scott Gottlieb is leaving after a record number of drug approvals. If history is any guide, his successor will likely preside over a dip in output.
Approvals FDA

Janssen’s Spravato Enters US Market With Enhanced REMS And Plans For A Monotherapy Trial

Restrictive risk management plan for antidepressant nasal spray requires patients be monitored for two hours after dosing and enroll in a patient registry; Janssen has agreed to conduct a monotherapy efficacy trial as a postmarketing commitment.

Approvals Drug Approval Standards

EU ‘Repurposing’ Project Plans Pilot Phase

A dedicated working group is taking forward a drug repurposing proposal originally devised by European industry bodies, with a view to determining the procedures to be used and running a pilot project with individual drug candidates.
Research and Development Strategies Regulation
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Drug Reviews

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Latest From Drug Review

US FDA Reorg Emphasizes Office of Therapeutic Biologics and Biosimilars

Final reorganization structure includes new office within OND to coordinate review of biologics and biosimilars applications, as well as new oncology and hematology divisions.

FDA Biosimilars

Keeping Track: Two Goal Date Extensions, Another Herceptin Biosimilar Approval, And A BLA Withdrawal

The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA Performance Tracker Drug Review

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

J&J’s Esketamine: A Model “Breakthrough” Program For US FDA

J&J’s treatment-resistant depression drug esketamine had an easy time at an FDA advisory committee despite raising some tough regulatory questions. If you are looking for a showcase of how “Breakthrough” drug development collaboration can help a new therapy get to patients faster, this might be it.

Review Pathway Approvals

Real-Time Oncology Review Quickly Grows Popular; Venclexta Is Latest To Join Pilot

Genentech/AbbVie drug becomes the seventh product known to be pilot-testing US FDA's new pathway; our infographic details the program's goals and how it has been used so far for more efficient reviews of supplemental oncology indications.
Drug Review Review Pathway

Breakthrough Designation Rescissions: Who Might US FDA Drop Next?

Our chart details the pipeline candidates who might lose the coveted status as treatment paradigms change and trial results come in.
Review Pathway Drug Review
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