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Novel US FDA Approvals Could Rebound In 2017: 40+ Candidates Already Under Review

Novel approvals by US FDA in 2017 could easily surpass the 28 agents approved by the agency's drug and biologics centers in 2016. The big question is whether last year's spike in complete response letters was an anomaly or the start of a trend.

Approvals Review Pathway

EU Decentralized Procedure Pilot Seeks To Speed Up Validations

All marketing approval applications submitted via Europe’s decentralized procedure are being processed under a new pilot that should help regulators validate applications faster. The pilot might also give companies a better understanding of the validation process and how omissions or mistakes in their documentation might invalidate or delay their applications.

Review Pathway Drug Review

Podcast: FDA’s Leah Christl Talks Biosimilars

US agency's Associate Director for Therapeutic Biologics Leah Christl gives the most up-to-date snapshot of biosimilar regulatory development, the potential areas for further FDA collaboration with European regulators – and how long it may be until the agency approves the first interchangeable biosimilar.

Biosimilars Review Pathway

QIDP Designations

Qualified Infectious Disease Product Designations granted by FDA. Updated upon new designations.

Performance Tracker Review Pathway

Generic Drug Review At US FDA: Has Submission Rush Ended Or Just Paused?

Excitement to get a 10-month ANDA review may have waned in January as submissions plummet, but can approvals keep up?

Approvals Generic Drugs

Trump Promises Changes To 'A Lot Of Rules' At US FDA

In meeting with PhRMA, president says FDA approval must be faster and that a commissioner pick is coming.

Drug Review FDA

RAT Race Begins: FDA Accepting Regenerative Advanced Therapy Designation Requests

As part of a flurry of actions in the waning days of the Obama Administration, FDA formally announced a process for requesting the new “Regenerative Advanced Therapy” designation. Much like the early days of “Breakthrough,” the standards are uncertain for now.

FDA Review Pathway

Advair Competition: Teva’s AirDuo Approved But Not Therapeutically Equivalent

US FDA approves Teva’s fluticasone/salmeterol fixed-dose combination product under the 505(b)(2) NDA route with an asthma indication but no labeling claim for chronic obstructive pulmonary disease.

Approvals Regulation

Bristol, AstraZeneca Changes To IO Strategy Could Ultimately Be Regulatory Gain

Bristol's filing of Yervoy/Opdivo in first-line lung cancer is delayed as the company drops its plans for accelerated approval, but could be on a more solid regulatory footing if the pivotal trial is successful. Meanwhile, AstraZeneca is using adaptive trial design to update MYSTIC, which could result in broader approvals.

Clinical Trials Cancer
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