Drugs and Devices

‘Smart’ drug not beneficial

The “smart” drug Modafinil, which many students take to improve their ability to study and increase exam success does not…

2009 Pharmaceutical Grow

IMS Health reports a 5.1% growth in 2009 U.S. sales of pharmaceuticals, to $300.3 billion, compared to a 1.8% growth…

2015 top patient safety concerns

Alarm hazards top the “Top 10 Patient Safety Concerns for Healthcare Organizations,” released by ECRI Institute. Data integrity and managing…

Abbott recalls infant formula

On Sept. 22, Abbott initiated a voluntary recall of certain Similac-brand powder infant formulas because of the possibility of a…

Abbott withdraws Meridia from market

On Oct. 8, Abbott Laboratories voluntarily withdrew its weight loss drug Meridia (sibutramine) from the market in response to a…

ACE inhibitors and acute kidney injury

Researchers in England found that increased prescribing of ACE inhibitors and angiotensin-receptor antagonists (ARAs) was associated with the increased rates…

Alaris Pump Module recall

CareFusion has recalled Alaris Pump Module, Models 8100 because of possible dysfunctions that could lead to pump stoppage. Read more.
alarm stats

Alarming stats about alarms

A study in the American Journal of Critical Care finds that compared to an earlier survey, almost twice as many…

Cannabis use in older adults

An article in The Gerontologist discusses the implications of the rising use of cannabis in older Americans. Read more
cdc fighting antibiotic resistance

CDC: Fighting antibiotic resistance

If you’re looking for ways to better contain bacteria with unusual antibiotic resistance, take a look at suggestions from the…

Counterfeit surgical mesh

On March 11, the U.S. Food and Drug Administration issued a warning about counterfeit surgical mesh being distributed under C.…

Cybersecurity and medical devices

On Jan. 15, the U.S. Food and Drug Administration (FDA) issued a draft guidance outlining important steps medical device manufacturers…

Davol XenMatrix Surgical Graft recall

The U.S. Food and Drug Administration notified healthcare professionals that several lots of XenMatrix Surgical Graft have been recalled because…

Defibtech, LLC, recall

Defibtech, LLC, has recalled DBP-2800 Battery Packs used in the Lifeline AED and ReviveR AED (semi-automatic external defibrillators). Read more…

Drug approval for breast cancer

The U.S. Food and Drug Administration has approved Tykerb (lapatinib) in combination with Femara (letrozole) to treat hormone positive and…
drug-diversion

Drug diversion in healthcare

Prevention and detection for nurses Special report to American Nurse Journal, supported by an educational grant from Fresenius Kabi USA.…

Ebola updates from FDA

The U.S. Food and Drug Administration (FDA) is working to help expedite the development and availability of medical product, such…

Electronic cigarettes are not harmless

A study in JAMA Cardiology reports that habitual use of electronic cigarettes is associated with negative physiologic effects. Read more 

Engage Introducer recalled

On Aug. 13, the U.S. Food and Drug Administration (FDA) announced the recall of 6 French Engage Introducers manufactured between…

FDA Advises to stop using Rotarix

On March 22, the U.S. Food and Drug Administration recommended a temporary suspension of the vaccine Rotarix although currently there…

FDA approvals

On June 1, the Food and Drug Administration (FDA) approved Netspot, the first kit for the preparation of gallium Ga…

FDA approvals—July 11-12, 2016

On July 12, the Food and Drug Administration (FDA) approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and…

FDA approves Afrezza

On June 27, the U.S. Food and Drug Administration (FDA) approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin…

FDA approves artificial heart valve

On June 17, the U.S. Food and Drug Administration (FDA) approved the SAPIEN 3 Transcatheter Heart Valve (THV) for patients…

FDA approves Brilinta for ACSs

The U.S. Food and Drug Administration (FDA) has approved Brilinta (ticarelor) for reducing cardiovascular death and heart attack in patients…

FDA approves CPR devices

On March 9 the U.S. Food and Drug Administration (FDA) approved the ResQCPR System, a system of two devices for…

FDA approves device to treat obesity

On January 14, the U.S. Food and Drug Administration (FDA) approved the Maestro Rechargeable System for certain obese adults, the…
fda abilify mycite pill tracker

FDA approves digital tracking pill

On Nov. 13, the U.S. Food and Drug Administration (FDA) approved Abilify MyCite, a pill with a sensor that digitally…

FDA approves drug for ALS

On May 5, the U.S. Food and Drug Administration (FDA) approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis…

FDA approves drug for rare lung disease

On May 28, the U.S. Food and Drug Administration (FDA) approved Rapamune (sirolimus), to treat lymphangioleiomyomatosis, a rare, progressive lung…

FDA approves drug for scorpion sting

The U.S. Food and Drug Administration (FDA) had approved Anascorp, the first specific treatment for a scorpion sting by Centruroides…
fda drugs breast cancer

FDA approves drugs for breast cancer

On July 18, the U.S. Food and Drug Administration (FDA) approved Kisqali (ribociclib) in combination with an aromatase inhibitor for…
fda approves first biosimilar neulasta

FDA approves first biosimilar to Neulasta

On June 4, the U.S. Food and Drug Administration (FDA) approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to…

FDA approves generic Abilify

On April 28, the U.S. Food and Drug Administration (FDA) approved the first generic versions of Abilify (aripiprazole). Read more.

FDA approves head lice treatment

The U.S. Food and Drug Administration has approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice in…

FDA approves Levaquin for plague

On April 27, the U.S. Food and Drug Administration approved Levaquin (levofloxacin) to treat patients with plague. The drug was…

FDA approves losartan generic

On April 6, the U.S. Food and Drug Administration approved the first generic versions of two drugs used for the…

FDA approves medical device for ADHD

On April 19, the FDA permitted marking of the first medical device to treat attention deficit hyperactivity disorder (ADHD): Monarch…

FDA approves new anticlotting drug

On January 8, the U.S. Food and Drug Administration (FDA) approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the…
fda approves new birth control ring

FDA approves new birth control ring

On August 10, U.S. Food and Drug Administration (FDA) approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), which is…

FDA approves new cholesterol-lowing drug

On July 24, the U.S. Food and Drug Administration (FDA) approved Praluent (alirocumab) injection, the first cholesterol-lowering treatment approved in…

FDA approves new COPD treatment

On July 23, the U.S. Food and Drug Administration (FDA) approved Tudorza Pressair (aclidinium bromide) for the long-term maintenance treatment…

FDA approves new daily treatment for RLS

The U.S. Food and Drug Administration has approved Horizant Extended Release Tablets (gabapentin enacarbil) as a daily treatment for moderate-to-severe…

FDA approves new device for asthma

On April 27, the U.S. Food and Drug Administration approved the first medical device that uses radiofrequency energy to treat…

FDA approves new diabetes drug

On March 29, the U.S. Food and Drug Administration (FDA) approved Invokana (canagliflozin) tablets to treat adults with type 2…

FDA approves new drug for CIC

On Jan. 29, the U.S. Food and Drug Administration (FDA) approved Trulance (plecanatide) for the treatment of chronic idiopathic constipation.…

FDA approves new drug for COPD

The U.S. Food and Drug Administration has approved roflumilast, an oral drug that reduces exacerbations from severe chronic obstructive pulmonary…

FDA approves new drug for eczema

On March 28, the U.S. Food and Drug Administration (FDA) approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema.…

FDA approves new drug for gout

On Dec. 22, the U.S. Food and Drug Administration (FDA) approved Zurampic (lesinurad) to treat high levels of uric acid…

FDA approves new drug for heart failure

On July 7, the U.S. Food and Drug Administration (FDA) approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure.…

FDA approves new drug for hyperkalemia

On Oct. 22, the U.S. Food and Drug Administration (FDA) approved eltassa (patiromer for oral suspension) to treat hyperkalemia. Read…

FDA approves new drug for lupus

The U.S. Food and Drug Administration has approved Benlysta (belimumab) for treatment of lupus. The FDA last approved a drug…

FDA approves new drug for osteoporosis

On June 1, the U.S. Food and Drug Administration (FDA) approved Prolia (denosumab), an injectable treatment for postmenopausal women with…

FDA approves new drug for PAH

On Dec. 22, the U.S. Food and Drug Administration (FDA) approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial…

FDA approves new drug for psoriasis

On January 21, the U.S. Food and Drug Administration (FDA) approved Cosentyx (secukinumab) to treat adults with moderate-to-severe plaque psoriasis.…

FDA approves new drug for psoriasis

On Feb. 15, the U.S. Food and Drug Administration (FDA) approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis.…

FDA approves new drug for schizophrenia

The U.S. Food and Drug Administration has approved Latuda (lurasidone HCL) tables for the treatment of adults with schizophrenia. Read…

FDA approves new drug for thyroid cancer

On February 13, the U.S. Food and Drug Administration (FDA) approved Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid…
antibacterial drug fda urinary tract infection ant

FDA approves new drug for UTI

“The FDA is committed to making new safe and effective antibacterial drugs available,” said Edward Cox, M.D., director of the…

FDA approves new drugs

On Sept. 2, the U.S. Food and Drug Administration (FDA) approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and…

FDA approves new drugs

·On Sept. 22, the U.S. Food and Drug Administration (FDA) approved Lonsurf (a pill that combines two drugs, trifluridine and…

FDA approves new drugs

· On Nov. 16, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Darzalex (daratumumab) to treat patients…

FDA approves new drugs

On Nov. 24, the U.S. Food and Drug Administration (FDA) approved: Fluad, the first seasonal influenza vaccine containing an adjuvant…

FDA approves new drugs

· On Dec. 8, the U.S. Food and Drug Administration (FDA) approved: · Vonvendi, von Willebrand factor (Recombinant), for use…

FDA approves new drugs

·On Dec. 16, the U.S. Food and Drug Administration (FDA) approved Basaglar (insulin glargine injection), a long-acting human insulin analog…

FDA approves new drugs for diabetes

On Sept. 25, the U.S. Food and Drug Administration (FDA) approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin…

FDA approves new hemophilia treatment

On June 6, the U.S. Food and Drug Administration (FDA) approved Eloctate, Antihemophilic Factor (Recombinant), Fc fusion protein, for use…

FDA approves new melanoma drug

The U.S. Food and Drug Administration (FDA) has approved Zelboraf (vemurafenib) for use in patients with metastatic or unresectable melanoma…

FDA approves new MRI agent

The U.S. Food and Drug Administration (FDA) has approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of…

FDA approves new MS drug

On Sept. 12, the U.S. Food and Drug Administration (FDA) approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of…

FDA approves new treatment for eczema

On Dec. 14, the Food and Drug Administration (FDA) approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema in…

FDA approves new weight-loss drug

On July 17, the U.S. Food and Drug Administration (FDA) approved Qsymia (phentermine and topiramate extended-release) as an addition to…