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Product Reviews & Approvals

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Approvals

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Latest From Approvals

Ocrevus Launching Quickly Even After Manufacturing Worries Delayed US Approval

Genentech’s ocrelizumab, a CD20-directed antibody, becomes first US-approved treatment for primary progressive multiple sclerosis and is also indicated for relapsing disease. Labeling includes warnings about infusion reactions, infections and malignancy but lacks a boxed warning or REMS.

Approvals Biologics

CHMP’s March Recommendations Include Dinutuximab, Nonacog Beta Pegol And Trumenba

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) meets monthly to review applications for centralized EU marketing authorization. Here’s a summary of their March 2017 recommendations.

Approvals Europe

User Fees: Should US FDA Incur Penalties For Missed Deadlines?

Sen. Burr asks FDA whether fee revenue should be rebated for not meeting some PDUFA V goals.

Approvals FDA

Keeping Track: US FDA Clears Three Novel Agents Over Three Days – Bavencio, Symproic And Xadago

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

Performance Tracker Approvals

FDA's NDA And BLA Approvals: Xadago, Bavencio, Symproic

Original new drugs and biologics recently approved by US FDA.

Approvals Regulation

Newron's Parkinson's Drug Xadago Has Narrower Indication Than Teva's Azilect

After overcoming regulatory hurdles, Newron may have tough time competing in US against market stalwart Azilect; eight Parkinson's drugs are in Phase III trials.

Approvals Regulation
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Drug Reviews

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Latest From Drug Review

Genentech's Subcutaneous Rituximab Breezes Through US FDA Advisory Committee

Lack of concerns about reformulation of product among either Oncologic Drugs Advisory Committee members or FDA reviewers and the decades-long existence of the molecules raises questions as to why the meeting was needed.

Advisory Committees Drug Review

Subcutaneous Rituximab Seems Headed For US FDA Advisory Panel OK

Genentech used pharmacokinetic bridging studies for new route of administration, which uses the enzyme hyaluronidase and is strongly preferred by patients over the IV; firm is seeking indications for follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia.

Advisory Committees Drug Review

User Fees: Should US FDA Incur Penalties For Missed Deadlines?

Sen. Burr asks FDA whether fee revenue should be rebated for not meeting some PDUFA V goals.

Approvals FDA

Recent And Upcoming FDA Advisory Committee Meetings

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

Regulation Advisory Committees

100% User Fees For US FDA? Trump Budget Revives Important Issue For Industry – But Not This Year

Trump Administration’s surprising call for increased user fees probably won’t have much impact on pending reauthorization process, but it does put on the table an important question for the biopharma industry to consider for the long term: should FDA be fully funded by user fees?

FDA Legislation

Gottlieb's FDA: Specialized Groups Could Create Review Consistency, Speed

US FDA commissioner nominee might employ modular specialists to work with review divisions on issues related to gene therapies, molecularly-targeted drugs, adaptive clinical trial designs, or other complex issues.

Drug Review FDA
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