Regulatory Affairs Syndicator

Takeda Pharmaceuticals North America, Inc. announced that the U.S. Food and Drug Administration has approved the New Drug Application for duetact , pronounced “Duet Act,” for the treatment of type 2 diabetes.

Political Gateway - LONDON, July 31 (UPI) — A drug designed to attack cancer by inhibiting a key enzyme to signals cells to multiply became available Monday across Britain. Already licensed by the U.S. Food and Drug Administration, Sutent (sunitinib) has been licensed …

GSK files allergy drug with EMEA and FDATherapeutics Daily (subscription) (press release), PA - 2 hours ago… allergy drug fluticasone furoate, under the proposed trade name Avamys/Allermist, to both the European Medicines Agency and the US …

Britain gets cancer 'wonder drug'United Press International - 1 hour agoAlready licensed by the US Food and Drug Administration, Sutent (sunitinib) has been licensed in Britain to treat two kidney cancer and gastrointestinal …

Atlanta Business Chronicle - CBST) on the drug HepeX-B, but said Cubist stopped its investment in the project because of stringent Food and Drug Administration requirements. Xoma and Cubist made a deal in September 2005 in which Xoma worked to find new ways of manufacturing …

Merck & Co. Inc., racing to compete in a growing diabetes-treatment market, said it has asked regulators to approve an additional version of its yet-unapproved new prescription drug Januvia.

Abbott Laboratories Inc. said Monday the Food and Drug Administration has approved its anti-inflammatory drug Humira for a third use.

Abbott Laboratories Inc. said Monday the Food and Drug Administration has approved its anti-inflammatory drug Humira for a third use.

July 31, 2006 - CytRx Corporation today announced completion of the Phase I clinical trial of the novel HIV DNA + protein vaccine that it has exclusively licensed.

FDA has announced it is proceeding to work with Duramed, a subsidiary of Barr Pharmaceuticals, to resolve the remaining policy issues associated with the marketing of Plan B as an over-the-counter option.

In an 11th hour move, the Food and Drug Administration said on Monday it is reconsidering over-the-counter sales of Plan B, the so-called morning after pill, which scientists said nearly three years ago was safe enough to be sold without a prescription.

Phyton Biotech And Insmed Sign Development Agreement - Quick FactsTrading Markets, CA - 1 hour agoThe company stated that the Food and Drug Administration approved IPLEX in December 2005 for the treatment of growth failure in children with se…

The government is considering allowing over-the-counter sales of the morning-after pill to women 18 and older _ a surprise move Monday that revives efforts to widen access to the emergency contraceptive almost …

A once-daily treatment for Parkinson’s disease, designed to block the breakdown of a chemical that contributes to problems with movement and coordination, launched in the United States on Monday.

Financial News USA - Food and Drug Administration approved its genital herpes drug Famvir. The drug is a single-day treatment for recurrent genital herpes in patients with the ability to develop immune responses. The approved dosage involves two 1,000 milligram tablets …