The Advisory Committee for Reproductive Health Drugs and Drug Safety and the Risk Management Advisory Committee are likely to look at similar adverse events reported for other approved testosterone injectable products

Briefing documents released ahead of Wednesday's Pulmonary-Allergy Drugs Advisory Committee pointed to some inconsistent data for Breo (fluticasone furoate/vilanterol), the combination inhaled corticosteroid and long-acting beta2 agonist (LABA) from GlaxoSmithKline plc and Theravance Inc

This is a new indication for FDA, and the standard approach would be to go to an advisory committee," Mills said

Ironwood Pharmaceuticals Inc., of Cambridge, Mass., added Benjamin Cravatt to its pharmaceutical advisory committee

analyst Eric Schmidt said in a January research note, "Tecfidera is one thing we do not worry about." (See BioWorld Today, Jan. 29, 2013.) Wall Street also saw a positive omen in the fact that the FDA declined to schedule an advisory committee meeting to discuss Tecfidera's risk/benefit profile, despite public pressure from MS competitor Teva Pharmaceutical Industries Ltd

Safety concerns were front and center at Thursday's meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) reviewing Titan Pharmaceuticals Inc.'s application for Probuphine, an implantable device delivering a steady dose of buprenorphine for up to six months for opioid dependence

Briefing documents released ahead of a scheduled meeting March 21 of the Psychopharmacologic Drugs Advisory Committee sent shares of Titan Pharmaceuticals Inc

The FDA's Oncologic Drugs Advisory Committee was convinced, voting 15 to 1 in favor of the drug

The company said it expects an advisory committee meeting to be scheduled between late June and late July

The FDA has scheduled an advisory committee meeting May 3 to discuss the safety and efficacy of the currently approved drugs as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident.

The company said it expects an advisory committee meeting to be scheduled between late June and late July

They also pledged to uphold aspects of independence for advisory committees and included provisions to ensure research undergoes peer review

The Reproductive Health Drugs and the Drug Safety and Risk Management advisory committees voted 20-1 that sponsors of calcitonin drugs in development should be required to submit fracture efficacy data for approval

A sequestration of the magnitude contemplated, and this late in the budget year, will have public health consequences for an agency that is already making every dollar count." – Statement from FDA "We believe the hurdles for approval of a non-hormonal treatment for hot flashes remain high." – Jim Schoeneck, president and CEO, Depomed Inc., following the FDA's Reproductive Health Drugs Advisory Committee vote of 12-2 against its product Sefelsa

served to delay the scheduled FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting last week, South San Francisco-based Theravance Inc

Unigene Laboratories Inc., of Boonton, N.J., said that the outcome of an FDA Advisory Committee Meeting on March 5 regarding calcitonin salmon for postmenopausal osteoporosis will have a materially adverse effect on its finances and operations

Drugmakers with calcitonin salmon products under development for postmenopause osteoporosis (PMO) may have to do a lot more work to get the drugs approved following a joint FDA advisory committee meeting Tuesday...The Reproductive Health Drugs and the Drug Safety and Risk Management advisory committees voted 20-1 that sponsors of calcitonin drugs in development should be required to submit fracture efficacy data for approval

The modest reduction in menopause-related vasomotor symptoms (VMS) recorded in three Phase III trials was not sufficient to warrant the side-effect risk associated with gabapentin, according to the FDA's Reproductive Health Drugs Advisory Committee, which voted 12-2 Monday to recommend against Depomed Inc.'s Sefelsa (formerly Serada