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FDA Advisory Panel Unmoved by Gepirone Data

Recommends against novel antidepressant; FDA's fairness questioned

Evidence Lacking for Some Fluoroquinolone Use

FDA panel says risk-benefit data don't support current labeling

FDA Presses Pause on Novel Testosterone Product

Gives FDA chance to "back away from the circus," says sponsor's CEO

Is SAMHSA to Blame for a Broken Mental Health System?

Two members of Congress differ on how to fix a failing system

'Too Toxic' Colorectal Cancer Drug Now OK'd

FDA approves tipiracil-trifluridine combo, to be sold as Lonsurf

Some Yohimbe Supplements Stronger than Labeled

Pharmaceutical-grade yohimbine, used for sexual dysfunction, is passing for a botanical supplement

FDA Approves First PCSK9 Inhibitor

Indication given for heterozygous HF and secondary prevention

FDA Approves Drug for Basal Cell Carcinoma

Sonidegib becomes second hedgehog inhibitor for locally advanced disease.

Purdue Pulls New OxyContin Application, and Questions Follow

FDA disavows previous requirement for study of abuse-deterrent formulation

Pricey Drugs Prompt AMA to Ask FDA and FTC for Help

This time it's generics not brands

Evolocumab Receives Mixed FDA Review

FDA sees strong efficacy of new injectable heart drug, but questions appropriateness of study population

FDA Okays Stiolto for COPD

Will include black-box warning about increased risk of asthma-related death.

Three Diabetes Drugs Linked to Ketoacidosis, FDA Warns

FDA targets SGLT2 inhibitors canagliflozin, dapagliflozin, and empagliflozin.

FDA Panel Gets Earful on Homeopathy

Speakers ranged from harsh critics to vocal proponents.

Slippery Slope: Diet Drugs No Help for Heart

In another edition of the Slippery Slope series examining use of surrogate endpoints in drug approvals, 番茄社区 and the Milwaukee Journal Sentinel find diet drugs are approved without solid evidence of benefits, but with hints of harm.

Slippery Slope: $$ in, Diet Drugs Out, How Five Drugs Came to Market

Makers of diet drugs spent more than $60 million on payments to doctors, organized medicine, and lobbyists to get their drugs approved.

SNUS: Is This a 'Safe' Tobacco Product?

Swedish smokeless tobacco maker wants FDA to soften warning label.

Citing Risks, FDA Calls for Label Changes to T Therapy

Agency requires warning on heart attacks, strokes with testosterone replacement.

HDAC Inhibitor OK'd for Multiple Myeloma

Panobinostat targets histone deacetylases; first of its kind to win approval in myeloma.

Cosentyx Gets FDA Nod for Psoriasis

Anti-IL17 drug secukinumab OK'd for moderate-to-severe disease.

FDA Advisers Unimpressed by Nocdurna

Another setback for nocturia indication

FDA Launches Compounding Advisory Committee

The 14 committee members come from a variety of disciplines.

AstraZeneca's Move to Protect Nexium Market Ruled Legal

"Pay to delay" strategy upheld by court.

FDA Panel Wants Safer Epidural Steroid Shots

Majority votes to end epidural injections with "particulate" steroids.

FDA Panel Torn on Watchman Device

Calls the device safe, but splits on its efficacy.

FDA: Black Box Warning on Viscous Lidocaine for Teething

WASHINGTON -- Topical viscous lidocaine should not be used to treat infants' teething pain, the FDA said Thursday, emphasizing that teething pain generally needs no medicinal treatment.

FDA Panel Puts Brakes on Anti-PARP Drug

WASHINGTON -- Approval of a PARP inhibitor for patients with advanced ovarian cancer should await results of an ongoing clinical trial that has the potential to answer questions about the drug's safety and efficacy, according to an FDA advisory committee that voted against immediate approval.

AMA Highlights: VA, Cheerleaders, and Guns

CHICAGO -- Wrapping up a full agenda, the AMA agrees cheerleading is a sport, doctors outside the VA need to pitch in to help care for veterans, and e-cigarettes need to be regulated.

Give Me That Old Time AMA

After an absence of a few years, I find myself back in Chicago for the AMA's annual meeting and discover that not much has changed.

How To Tell Fake Neck Pain From Real: The Pain Medicine News Report

A regular update on what鈥檚 new in surgery from our friends at Pain Medicine News.

Medtronic's Infuse Moves From Operating Room to Courtroom

An investigative series by 番茄社区/Milwaukee Journal Sentinel has been tracking the spinal fusion device called Infuse in a 4-year-long series and now reports how a flawed FDA system for device approval may have led to a long string of adverse events culminating in thousands of liability suits.

FDA Slashes Starting Dose for Lunesta

SILVER SPRING, Md. -- Patients starting on the sleep drug eszopiclone (Lunesta) should take no more than 1 mg at bedtime -- one-third the current label-recommended dose -- because of the risk of next-day impairment, the FDA said Thursday.

FDA Panel Nixes OTC Singulair

Montelukast (Singulair) should not be allowed over-the-counter use for hay fever and other upper respiratory allergy symptoms, an FDA advisory panel recommended Friday.

FDA Warns of Cancer Risk With Laparoscopic Device

WASHINGTON -- Hysterectomy and procedures to remove uterine fibroids should avoid use of laparoscopic power morcellation, according to a safety advisory from the Food and Drug Administration.

FDA Panel Says Yes to Inhaled Insulin Device

HYATTSVILLE, Md. -- An FDA advisory panel has voted in favor of approving a new inhaled insulin device, Afrezza, as a short-acting treatment to improve glycemic control in both type 1 and type 2 diabetes.

Cologuard Cancer Test Aces FDA Panel Review

WASHINGTON -- An FDA advisory committee unanimously affirmed the safety and efficacy of a DNA stool test for colorectal cancer screening.

Culture Shock: Homeopathic Recall is No Joke

Did you hear about the homeopathic physician who was treating himself and one day forgot to take his pills?

CT Appears Safe in Patients With Pacemakers, ICDs

Patients with cardiac rhythm management devices showed no clinically significant major or minor events related to computed tomography imaging over a 10-year period at two large-volume care centers, researchers reported.

FDA OKs Northera for Hypotension

The FDA has approved droxidopa (Northera) for the treatment of neurogenic orthostatic hypotension, a rare disease that results in a drop in blood pressure when patients try to stand up.

Droxidopa for OH Slammed by FDA Reviewers

SILVER SPRING, Md. -- Droxidopa (Northera) is getting a second look by an FDA advisory committee for the treatment of orthostatic hypotension stemming from neurological disorders like Parkinson's disease, but an agency review doesn't look promising for approval.

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