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November 09, 2016
What’s ahead for the healthcare and pharmaceutical industries?
November 02, 2016
The biosimilar pathway permits licensure based on less than full clinical data.
October 24, 2016
FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.
October 20, 2016
FDA leaders insist that the decision to approve Sarepta’s Exondys (eteplirsen) should not be considered a model for future development of orphan drugs.
October 10, 2016
PharmTech's Editorial Director, Rita Peters, addresses the CPhI Pharma Awards' finalists at this year's CPhI Awards Gala.
October 05, 2016
Value assessment initiatives are expected to have a major impact on drug use and reimbursement.
September 15, 2016
Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.
September 12, 2016
Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.
September 09, 2016
If FDA’s proposed generic-drug labeling rule is passed in 2017, generic drug companies would need documented processes for safety tracking and label updates.
August 30, 2016
Can Competition Block Excessive Pharma Price Hikes? EpiPen Saga Shows It’s Hard