乌鸦传媒

Washington Watch

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<乌鸦传媒>FDA Lifts Restriction On Rosiglitazone

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

<乌鸦传媒>Slippery Slope: A Targeted Therapy That Misses the Mark?

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

<乌鸦传媒>Chewable Stimulant OK'd for ADHD

Indicated for patients age 6 and older

<乌鸦传媒>FDA Advisory Panel Unmoved by Gepirone Data

Recommends against novel antidepressant; FDA's fairness questioned

<乌鸦传媒>Evidence Lacking for Some Fluoroquinolone Use

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

<乌鸦传媒>FDA Presses Pause on Novel Testosterone Product

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

<乌鸦传媒>Is SAMHSA to Blame for a Broken Mental Health System?

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

<乌鸦传媒>'Too Toxic' Colorectal Cancer Drug Now OK'd

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

<乌鸦传媒>Some Yohimbe Supplements Stronger than Labeled

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

<乌鸦传媒>Patient Registries See Promise and Challenges Ahead

Physician-driven registries adapt to a changing health system

<乌鸦传媒>FDA Approves First PCSK9 Inhibitor

Indication given for heterozygous HF and secondary prevention

<乌鸦传媒>FDA Approves Drug for Basal Cell Carcinoma

Sonidegib becomes second hedgehog inhibitor for locally advanced disease.

<乌鸦传媒>Diabetic Seniors Lobby for Medicare to Cover CGM Devices

Senate panel highlights glucose control issues facing Medicare patients with diabetes.

<乌鸦传媒>Purdue Pulls New OxyContin Application, and Questions Follow

FDA disavows previous requirement for study of abuse-deterrent formulation

<乌鸦传媒>House Committee Votes to Defund AHRQ

Attempt to restore funding fails on voice vote

<乌鸦传媒>Pricey Drugs Prompt AMA to Ask FDA and FTC for Help

This time it's generics not brands

<乌鸦传媒>Evolocumab Receives Mixed FDA Review

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

<乌鸦传媒>FDA Okays Stiolto for COPD

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

<乌鸦传媒>Three Diabetes Drugs Linked to Ketoacidosis, FDA Warns

FDA targets SGLT2 inhibitors canagliflozin, dapagliflozin, and empagliflozin.

<乌鸦传媒>FDA Panel Gets Earful on Homeopathy

Speakers ranged from harsh critics to vocal proponents.

<乌鸦传媒>Slippery Slope: Diet Drugs No Help for Heart

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

<乌鸦传媒>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.

<乌鸦传媒>SNUS: Is This a 'Safe' Tobacco Product?

Swedish smokeless tobacco maker wants FDA to soften warning label.

<乌鸦传媒>Citing Risks, FDA Calls for Label Changes to T Therapy

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

<乌鸦传媒>HDAC Inhibitor OK'd for Multiple Myeloma

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

<乌鸦传媒>Cosentyx Gets FDA Nod for Psoriasis

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

<乌鸦传媒>FDA Advisers Unimpressed by Nocdurna

Another setback for nocturia indication

<乌鸦传媒>FDA Launches Compounding Advisory Committee

The 14 committee members come from a variety of disciplines.

<乌鸦传媒>AstraZeneca's Move to Protect Nexium Market Ruled Legal

"Pay to delay" strategy upheld by court.

<乌鸦传媒>FDA Panel Wants Safer Epidural Steroid Shots

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

<乌鸦传媒>FDA Panel Torn on Watchman Device

Calls the device safe, but splits on its efficacy.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>Calif. Docs Among Top Billers for Complex Visits

Three California doctors are among the top five nationally in billing for the most complex office visits, according to data released by Medicare and analyzed by ProPublica and KQED.

<乌鸦传媒>Medtronic's Infuse Moves From Operating Room to Courtroom

An investigative series by 乌鸦传媒/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.

<乌鸦传媒>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.

<乌鸦传媒>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.

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