FDA

Examination of cancer drug approvals shows FDA is faster than EMA, disproving an ‘urban myth’

Monday, July 11, 2011 08:00 AM

It has been a long-held belief that European regulators are willing to take more innovative approaches to ushering drugs through the regulatory process. And several recent reports have criticized the FDA for being inefficient in its approval process for medical devices compared to the European Medicines Agency (EMA). Complaints about cancer drugs being held up in the U.S. regulatory process are particularly widespread.

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FDA says drug approvals highest in two decades

Friday, July 8, 2011 02:15 PM

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, testified before the U.S. House Energy and Commerce's health subcommittee that first-cycle drug approvals are at a 20-year high, and more than two-thirds of new treatments are being cleared within the time frames given to new drug applications.

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Study results support BYDUREON’s NDA

Friday, July 8, 2011 12:21 PM

Amylin Pharmaceuticals, Eli Lilly and Alkermes announced results from QT (tQT) study of exenatide to increase the QT interval across a wide range of plasma concentrations. The study was conducted to satisfy a requirement by the FDA in support of the New Drug Application (NDA) for BYDUREON (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes.

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Medivir receives Fast Track designation from FDA

Wednesday, July 6, 2011 01:21 PM

Medivir’s investigational protease inhibitor TMC435 has received Fast Track designation from the FDA for treatment of chronic hepatitis C (CHC) genotype-1 infection, based on its potential to address medical needs in CHC infection compared to currently approved therapies.

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FDA approves first LazandaR nasal spray

Wednesday, July 6, 2011 10:03 AM

Archimedes Pharma and its subsidiary, Archimedes Pharma U.S., have won FDA approval of LazandaR (fentanyl) nasal spray for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain.

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FDA to post inspection information online

Thursday, June 2, 2011 01:46 PM

The FDA will publish more details about inspections and court actions on its web site as part of a drive toward transparency, according to a report on InPharm.

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U.S. R&D productivity often undercounted, as most reports omit FDA biologics approvals

Tuesday, May 31, 2011 09:44 AM

Most reports of pharmaceutical R&D productivity undercount the number of new drugs that reach the market each year, missing out on billions of dollars of sales, because they omit approvals from the Food and Drug Administration’s (FDA) biologics division, according to a new report by London-based research company EvaluatePharma.

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Abbott receives FDA approval for molecular test for HVC

Thursday, May 19, 2011 10:35 AM

Abbott has received approval from the FDA to market its RealTime PCR (polymerase chain reaction) test for measuring the viral load of hepatitis C (HCV). 

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FDA drug approvals on the rise despite slow development time

Wednesday, May 11, 2011 01:02 PM

The FDA has passed nearly twice as many biopharmaceutical drug approvals in the last 10 years than it did in the 1990s, a news release from the Tufts Center for the Study of Drug Development (CSDD) has indicated, according to Mass High Tech.

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FDA approves Novartis drug to treat pancreatic neuroendocrine tumors

Friday, May 6, 2011 12:34 PM

The FDA has approved the Novartis drug Afinitor(everolimus) for the treatment of advanced pancreatic neuroendocrine tumors. 

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