FDA drug approvals

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…
Web Exclusive! An update of drug news, including alerts, approvals, and removals at www.AmericanNurseToday.com/journal.
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  …
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…
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…
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.
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…
On May 5, the U.S. Food and Drug Administration (FDA) approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS). Read more
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.…
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…
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…
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)…
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.
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…
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…
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.…
On April 28, the U.S. Food and Drug Administration (FDA) approved the first generic versions of Abilify (aripiprazole). Read more.
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.…
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…
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…
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).…
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…
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…
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…
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
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…
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
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,…
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…
On Oct. 22, the U.S. Food and Drug Administration (FDA) approved eltassa (patiromer for oral suspension) to treat hyperkalemia. Read more.
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.
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…
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.…
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.
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…
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…
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.
The U.S. Food and Drug Administration has approved Latuda (lurasidone HCL) tables for the treatment of adults with schizophrenia. Read more here.
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…
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…
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.
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…
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
“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…
·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…
· 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…
· 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…
·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…
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…
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…
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.
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…
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…
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…
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
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…
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.
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…
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
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…
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.
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…
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.
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…
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…
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.…
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)…
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…
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…
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…
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.
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
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…
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
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
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
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
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,…

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…

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…

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…

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.…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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 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)…

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.…

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…

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…

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 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…

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…
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…

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…

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…

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…

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…

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…

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…

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…

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 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…

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…

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.…

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…

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…
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,…
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…
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…
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…

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