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FDA General

ADHD: How Did It Leap from Classroom to Boardroom?

Adults are now routinely diagnosed with ADHD. Why is that? This Lowering the Bar; Medicine in 21st Century report seeks answers

Gluttony -- Once a Deadly Sin, Now a Treatable Disorder

This "Lowering the Bar: Medicine in the 21st Century" MedPageToday/Milwaukee Journal Sentinel report takes a hard look at binge-eating disorder

Smartphone App May Help Monitor Depression

Patients were amenable to data monitoring by docs

How to Avoid Misdiagnosis

How a patient makes you feel may affect your diagnostic acumen

FDA: Avoid Cipro, Similar Drugs for Common Infections

Agency says risks outweigh benefits

FDA Warns of Skin Reaction With Olanzapine

Zyprexa and Symbyax among products to get warning label

FDA Warning: Abilify Tied to Impulse Control Problems

In rare cases, may prompt "uncontrollable urges"

Saxagliptin, Alogliptin Linked to Heart Failure, FDA Warns

Decision comes 1 year after FDA advisory committee vote

FDA Lifts Restriction On Rosiglitazone

Agency sees no need for restrictions after easing them 2 years ago

Slippery Slope: A Targeted Therapy That Misses the Mark?

Afinitor racks up FDA approvals, but where is the evidence?

Chewable Stimulant OK'd for ADHD

Indicated for patients age 6 and older

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

Patient Registries See Promise and Challenges Ahead

Physician-driven registries adapt to a changing health system

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, 木瓜直播 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.

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