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The FDA has updated its list of planned guidances for the calendar year to include one on evaluating the abuse-deterrent properties of generic solid oral opioid drugs. Read More
Two state legislatures are considering biosimilar substitution bills, but are taking opposite approaches to the issues of prescriber notification and patient consent. Read More
The FDA will hold a June 5 public hearing at its White Oak, Md., campus to discuss FY 2016 regulatory science research priorities for generic drugs. Read More
Republican lawmakers warned the FDA March 4 to expect fiscal year 2016 funding levels to be in line with this year’s $4.4 billion, not the full $4.9 billion requested. Read More
The FDA March 6 gave a green light to the first U.S. biosimilar, finding Sandoz’s Zarxio clinically comparable to Amgen’s blockbuster chemotherapy product Neupogen. Read More
The House yesterday passed a bill that would allow drugs to be sold before the Drug Enforcement Agency permanently assigns them to a controlled substance schedule. Read More
The European Medicines Agency Tuesday approved Novartis’ Jakavi for patients with polycythemia vera — a rare blood cancer — who cannot take hydroxyurea. Read More
Generics maker Sandoz will pay out $12.64 million to settle accusations it misrepresented average sales price information in reports to Medicare. Read More
The FTC is fighting to keep secret the reports drugmakers must file with the commission on patent infringement litigation in an ongoing and closely watched pay-for-delay lawsuit with Actavis. Read More