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Product Reviews & Approvals

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Approvals

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Latest From Approvals

Keeping Track: FDA's Review Actions Carry On During Shutdown

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

Japan Approvals Include World Firsts For Romosozumab, Spinal Injury Cell Therapy

The latest group of new product approvals in Japan includes the first marketing clearances worldwide for fracture-reducing osteoporosis antibody romosozumab and a stem cell-based therapy for spinal cord injury, as well as two new Daiichi drugs and Pfizer's lung cancer therapy dacomitinib. 

Japan Approvals

Oncology Dominates As China Approves Record 48 New Drugs In 2018

Despite multiple adverse factors including a leadership shakeup and the departure of its top regulator, the China FDA seemed determined to refresh itself after a name change and to speed up new drugs to market.

China Approvals

EU New Drug Approvals 2018: Anticancers, Orphans, The First CAR-Ts – And More

New drug approvals in the EU were again dominated by oncology in 2018, although medicines for infectious diseases came a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some key new arrivals in the areas of multiple sclerosis, genetic disorders, metabolism and migraine.
Approvals Europe

US FDA’s Record Year For Drug Approvals? Wall Street Is Unimpressed

Pace of new US drug approvals is unprecedented, but investors continue to shun biopharma industry. Uncertainty about pricing environment is clearly outweighing the favorable regulatory climate. Stocks in the sector closed the year down more than 15% are still trading well below 2015 levels. 
Pricing Debate Approvals

42 New Substances Among 84 EU Approval Recommendations In 2018

The EMA’s CHMP recommended EU marketing authorization for a total of 84 new drugs in 2018, containing a total of 42 new active substances. They included the EU’s first two CAR-T cell therapies, Kymriah and Yescarta, which were also among the 21 orphan medicines to gain a positive opinion from the committee.
Approvals Europe
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Drug Reviews

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Latest From Drug Review

CBER's Regulatory Activity in 2018: A Reading List

The US FDA's biologics center invested heavily in preparation for coming waves of advanced therapies. 
Regulation Biologics

US FDA’s Biologics Center Faces Exciting 2019 After Quiet Year For Novel Approvals

CBER’s novel biologic approvals in 2018 were few, long, and with a low level of innovation. But the center’s work to build regulatory framework for emerging technologies is setting the stage for a different story in 2019.
Vaccines Biologics

Scenes From A Shutdown: US FDA Hides It Well

FDA's two recent advisory committee meetings at its White Oak campus offer no obvious clues that agency is struggling due to dwindling carryover balances and furloughed employees.
FDA Leadership

Keeping Track: FDA's Review Actions Carry On During Shutdown

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

Evenity Likely Headed For Approval With Amgen's Proposed Indication, But Postmarketing Requirements Remain Unclear

US FDA advisory committee splits on whether Amgen's osteoporosis drug romosozumab needs observational study or randomized controlled trial to assess cardiovascular risks. 
Advisory Committees Orthopedics
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