FDA drug approvals

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 HER2-positive advanced breast cancer in postmenopausal women for…

Drugs Today – September 2008

Web Exclusive! An update of drug news, including alerts, approvals, and removals at www.AmericanNurseToday.com/journal.

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 symptoms of dry eye disease. Read more  …

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 to improve glycemic control in adults with diabetes…

FDA approves antiplatelet drug for use during PCI

On June 22, the U.S. Food and Drug Administration (FDA) approved Kengreal (cangrelor), an I.V. antiplatelet drug, for use in adults undergoing undergoing percutaneous coronary intervention (PCI). Read…

FDA approves Boostrix for older people

The U.S. Food and Drug Administration (FDA) has approved the Boostrix vaccine to prevent tetanus, diphtheria, and pertussis in people 65 years and older. Read more.

FDA approves contrast agent for CNS MRI scans

The U.S. Food and Drug Administration has approved Gadavist (gadobutrol), a contrast agent for use in patients undergoing magnetic resonance imaging (MRI) of the central nervous system. Read…

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 (ALS). Read more

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 disease that primarily affects women of childbearing age.…

FDA approves drug for rare metabolic disorder

On Sept. 4, the U.S. Food and Drug Administration (FDA) approved Xuriden (uridine triacetate), the first FDA-approved treatment for patients with hereditary orotic aciduria, a rare metabolic disorder…

FDA approves drug to reduce risk of preterm birth

The U.S. Food and Drug Administration (FDA) has approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery in pregnant women with a history of at…

FDA approves drug to treat multi-drug resistant TB

On Dec. 31, 2012, the U.S. Food and Drug Administration (FDA) approved Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB)…

FDA approves first drug for myelofibrosis

The U.S. Food and Drug Administration has approved Jakafi (ruxolitinb), the first drug approved to treat patients with the bone marrow disease myelofibrosis. Read more.

FDA approves first drug for tardive dyskinesia

On April 11, the U.S. Food and Drug Administration (FDA) approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. It’s the first drug approved by the FDA…

FDA approves first generic version of Nexium

On January 26, the U.S. Food and Drug Administration (FDA) approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in…

FDA approves Gazyva for chronic lymphocytic leukemia

On Nov. 1, the U.S. Food and Drug Administration (FDA) approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia.…

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 generic Strattera for ADHD

On May 30, the U.S. Food and Drug Administration (FDA) approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.…

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 patients 4 years and older. Read more at…

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 approved under the agency’s Animal Efficacy Rule, which…

FDA approves Marqibo for rare type of leukemia

On Aug. 9, the U.S. Food and Drug Administration (FDA) approved Marqibo (vincristine sulfate liposome injection) to treat adults with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL).…

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 risk of stroke and dangerous blood clots (systemic…

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 a new class of drugs known as proprotein…

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 diabetes. Invokana has been studied as a stand-alone…

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 disease (COPD). Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm244989.htm

FDA approves new drug for cystic fibrosis

On July 2, the U.S. Food and Drug Administration (FDA) approved Orkambi (lumacaftor 200 mg/ivacaftor 125 mg) for the treatment of cystic fibrosis (CF) in patients 12 years…

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. Read more

FDA approves new drug for Gaucher disease

On August 19, the U.S. Food and Drug Administration (FDA) approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease,…

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 in the blood (hyperuricemia) associated with gout, when…

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 more.

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 for lupus in 1955. Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm246489.htm.

FDA approves new drug for metastatic lung cancer

On Oct. 9, the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) to treat patients with metastatic non-small cell lung cancer whose disease progressed during or after…

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 osteoporosis who are at high risk of fractures.…

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 hypertension (PAH). Read more.

FDA approves new drug for pancreatic cancer

On Oct. 22, the U.S. Food and Drug Administration (FDA) approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with metastatic pancreatic cancer…

FDA approves new drug for Parkinson’s disease

On March 21, the U.S. Food and Drug Administration (FDA) approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa…

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. Read more.

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 more here.

FDA approves new drug for serious skin infections

On June 20, the U.S. Food and Drug Administration (FDA) approved Sivextro (tedizolid phosphate) to treat patients with acute bacterial skin and skin structure infections caused by certain…

FDA approves new drug for severe asthma

On Nov. 4, the U.S. Food and Drug Administration (FDA) approved Nucala (mepolizumab) for use with other asthma medicines for the maintenance treatment of severe asthma in patients…

FDA approves new drug for skin infections

On August 6, the U.S. Food and Drug Administration (FDA) approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections. Read more.

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 cancer whose disease progressed despite receiving radioactive iodine…

FDA approves new drug for type 2 diabetes

On August 1, the U.S. Food and Drug Administration (FDA) approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with…
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 Office of Antimicrobial Products in the FDA’s Center…

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 to improve glycemic control in adult and pediatric…

FDA approves new drugs

· On Dec. 8, the U.S. Food and Drug Administration (FDA) approved: · Vonvendi, von Willebrand factor (Recombinant), for use in adults 18 years of age and older…

FDA approves new drugs

· On Nov. 16, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least…

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 tipiracil) for patients with advanced colorectal cancer who…

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 aspart injection) to improve glucose control in adults…

FDA approves new implanted hearing system

On March 17, the U.S. Food and Drug Administration announced the approval of the Esteem, an implanted hearing system for moderate to severe sensorineural hearing loss. Read the…

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 who have the BRAF V600E mutation. Read more.

FDA approves new melanoma treatments

On Oct. 28, the U.S. Food and Drug Administration (FDA) expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with…

FDA approves new treatment for advanced melanoma

On Nov. 10, the U.S. Food and Drug Administration (FDA) approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to…

FDA approves new treatment for carcinoid syndrome

On Feb. 28, the U.S. Food and Drug Administration (FDA) approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid…

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 patients 2 years of age and older. Read…
hepatitis c fda

FDA approves new treatment for hepatitis C

On July 18, the U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or…

FDA approves new treatment for metastatic melanoma

The U.S. Food and Drug Administration has approved Yervoy (ipilimumab) for the treatment of patients with metastatic melanoma. Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm1193237.htm.

FDA approves new treatment for multiple myeloma

On Nov. 30, the U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received…

FDA approves new type of drug for insomnia

On August 13, the U.S. Food and Drug Administration (FDA) approved Belsomra (suvorexant) tablets for treating insomnia. Belsomra is the first approved orexin receptor antagonist. Read more

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 a reduced-calorie diet and exercise for chronic weight…

FDA approves Perjeta for late-stage breast cancer

On June 8, the U.S. Food and Drug Administration (FDA) approved Perjeta (pertuzumab), a new anti-HER2 therapy, to treat patients with HER2-positive late-stage breast cancer. Read more.

FDA approves Pomalyst for advanced multiple myeloma

On Feb. 8, 2013, the U.S. Food and Drug Administration (FDA) approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease has progressed after being treated with…

FDA approves Simponi for ulcerative colitis

May 15, the U.S. Food and Drug Administration (FDA) approved a new use for Simponi (golimumab) injection: to treat adults with moderate to severe ulcerative colitis. Read more.

FDA approves Synribo for chronic myelogenous leukemia

On Oct. 26, the U.S. Food and Drug Administration (FDA) approved Synribo (omacetaxine mepesuccinate) for the treatment of adults with chronic myelogenous leukemia. Synribo blocks certain proteins that…

FDA approves Tanzeum to treat type 2 diabetes

On April 3, the U.S. Food and Drug Administration (FDA) approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type…

FDA approves treatment for hereditary angioedema

The U.S. Food and Drug Administration (FDA) has approved Firazyr (icatibant) Injection for the treatment of acute attacks of hereditary angioedema in people ages 18 years and older.…

FDA approves treatment of non-small cell lung cancer

The U.S. Food and Drug Administration (FDA) has approved Xalkori (crizotinib) to treat patients with late-stage non-small cell lung cancers who express the abnormal anaplastic lymphoma kinase (ALK)…

FDA approves two drugs for idiopathic pulmonary fibrosis

On Oct. 15, the U.S. Food and Drug Administration (FDA) approved Ofev (nintedanib) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418994.htm and Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis. Read more about nintedanib…

FDA approves vaccine for meningococcal disease

On Oct. 29, the U.S. Food and Drug Administration (FDA) approved Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria…

FDA approves Xeljanz for rheumatoid arthritis

On Nov. 6, the U.S. Food and Drug Administration (FDA) approved Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis who have had an inadequate…

FDA approves Zykadia for NSCLC

On April 29, the U.S. Food and Drug Administration (FDA) approved Zykadia for patients with a certain type of late-stage non-small cell lung cancer (NSCLC). Read more.
duodenoscope distal cap

FDA clears duodenoscope with disposable distal cap

On Sept. 20, the U.S. Food and Drug Administration (FDA) cleared Pentax ED34-i10T, the first duodenoscope with a disposable distal cap, which will improve access for cleaning and…

FDA expands approved use of Kalydeco for CF

On May 17, the U.S. Food and Drug Administration (FDA) expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis (CF), tripling the number of rage gene…
United States Food and Drug

FDA expands use of artificial heart valve

Expanded use approval relies on real world evidence The U.S. Food and Drug Administration today approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for…

FDA expands use of cooling cap

On July 3, the U.S. Food and Drug Administration (FDA) cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce alopecia during chemotherapy. This is…
ethics inbox right try ant

From the Ethics Box: Right to Try

My patient is terminally ill. There may be a treatment, but it isn’t FDA approved. Do patients have a right to try investigational treatments, and what are the…
estrogen women woman note

Take Note – August 2007

Good news for younger women taking estrogen     Estrogen therapy may have cardioprotective effects for women who start taking it in their 50s. A study from the Women’s Health…
type 2 diabetes

Take Note – July 2007

On-line video-based course on emergency preparedness   The need for better coordination between governmental agencies and hospitals became apparent after 9/11 and again after Hurricane Katrina. To fill this…
breast feeding breastfeeding baby

Take Note – November 2006

American Diabetes Association releases food guidelines for specific medical categories “When you’re talking about diabetes, there is no ‘one size fits all’ diet,” said Ann Albright, PhD, RD,…

Reader Survey

Please share your feedback! We’re interested to learn more about your experience with American Nurse Journal.

cheryl meeGet your free access to the exclusive newsletter of American Nurse Journal and gain insights for your nursing practice.

NurseLine Newsletter

  • Hidden

*By submitting your e-mail, you are opting in to receiving information from Healthcom Media and Affiliates. The details, including your email address/mobile number, may be used to keep you informed about future products and services.

Test Your Knowledge

What are the key elements to consider when creating a successful initial prompt for AI in nursing education?