WASHINGTON – After discussing it for the past two years, the FDA has set a due date, Aug. 17, for makers of extended-release and long-acting opioids to come up with a risk evaluation and mitigation strategy (REMS) for their products.

With a new road map in hand, Durata Therapeutics Inc. has its lead candidate, dalbavancin, back on course for what it hopes is the final lap to FDA approval for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

While they could have the answers in hand to the serious health issues facing workers at Japan's crippled Fukushima reactors, several biotechs may have to be content with learning the lessons of the ongoing disaster – and being ready for similar emergencies.

WASHINGTON – The biopharmaceutical industry could be one of the casualties as Congress and the president prepare the field for the battle of the 2012 budget.

WASHINGTON – Flexing its enforcement muscle, the Department of Health and Human Services (HHS) is threatening to exclude Forest Laboratories Inc.'s founder, CEO and president from participation in federal health care programs.

WASHINGTON – Caught in a vicious circle of spiraling drug imports, the FDA is scrambling to develop the tools and get the authority it needs to ensure the safety of the nation's medicine chest.

SILVER SPRING, MD – Hope overrode the FDA's concerns about clinical trial conduct when an advisory committee gave a thumbs up Tuesday to Novartis Pharmaceuticals Corp.'s Afinitor and Pfizer Inc.'s Sutent as treatments for pancreatic neuroendocrine tumors (pNET).

Like thousands of other federal workers, folks at the FDA and SEC kept their fingers crossed Friday, hoping the House and Senate would come to terms on a spending bill in time to keep the government from shutting down.

WASHINGTON – Everybody's doing it, even the FDA. Using social media, that is. But the online community can be hostile territory for biopharma as the FDA has provided little guidance on where drugmakers can go and what they can do in this 21st century neighborhood.

WASHINGTON – Optimism, and eight years of hard work, paid off for Optimer Pharmaceuticals Inc. Tuesday when an FDA advisory committee unanimously recommended approval of Dificid (fidaxomicin) as a treatment for Clostridium difficile infection (CDI).