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The FDA has given Akorn tentative approval to market a generic version of Novartis'Voltaren Ophthalmic Solution, a drug used for the treatment of post-operativeinflammation in ophthalmic surgeries.
Teva Pharmaceutical has won tentative FDA approval to market sumatriptan succinate, a generic version of GlaxoSmithKline's (GSK) Imitrex, a drug used for the acute treatment of migraine headaches.
Outgoing Senate Majority Leader Bill Frist's (R-Tenn.) last-minute effort to
push through the Bush administration's choice to be the FDA commissioner was
successful as the Senate voted overwhelmingly last night to approve the nomination.
The FDA is calling on the pharmaceutical industry to help its regulatory project managers gain a greater understanding of the drug manufacturing process as part of its ongoing effort to bridge the information gap between industry and the agency.
October saw the highest number of drug approvals of any month in 2006, which could become a record year for drug approvals, according to research by Friedman, Billings, Ramsey (FBR).
The Senate is attempting to enact biodefense protections before Congress recesses this week, but faces the daunting task of getting the House to agree to the language.
The average cost of developing a new therapeutic biotechnology product is more than $1.2 billion, including the costs of drugs that fail in testing and the time associated with bringing these products to market, according to a new study by the Tufts Center for the Study of Drug Development.
HHS has notified Acambis that it would no longer consider the firm for a contract under the U.S. government's modified vaccinia ankara (MVA) smallpox vaccine tender process.
The outgoing chairman of the Senate committee with jurisdiction over the FDA is calling on his colleagues to confirm Andrew von Eschenbach as the commissioner of the FDA before the end of the 109th Congress to provide the leadership necessary to change what he calls an agency in turmoil.
A group of physicians and advocacy groups is taking on pharmaceutical promotions, calling in a journal article for an overhaul of the way healthcare professionals are educated on how to handle them.