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Tag archive for ‘FDA approval’
By The Dispatch On Monday, August 11th, 2014
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Colorectal cancer: FDA approves Cologuard for colorectal screening

The U.S. Food and Drug Administration today approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain More...

By The Dispatch On Thursday, July 31st, 2014
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COPD drug, Striverdi Respimat, receives FDA approval

Today, the U.S. Food and Drug Administration approved Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema More...

By The Dispatch On Wednesday, July 23rd, 2014
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FDA approves Targiniq ER, extended-release oxycodone, to treat severe pain

Today, the U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat More...

By The Dispatch On Wednesday, July 23rd, 2014
1 Comment

Gilead Sciences cancer drug, Zydelig, receives FDA approval

The U.S. Food and Drug Administration today approved Zydelig (idelalisib) to treat patients with three types of blood cancers. Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic More...

By The Dispatch On Thursday, July 17th, 2014
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FDA approves Ruconest for the treatment of acute attacks in patients with hereditary angioedema

The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema More...

By The Dispatch On Thursday, July 3rd, 2014
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Spectrum Pharmaceuticals Beleodaq for non-Hodgkin lymphoma treatment gets FDA nod

The U.S. Food and Drug Administration today approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action More...

By The Dispatch On Saturday, June 28th, 2014
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Afrezza Inhalation Powder receives FDA nod for control of diabetes mellitus

The U.S. Food and Drug Administration today approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting More...

By The Dispatch On Tuesday, June 17th, 2014
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Novartis seeks FDA approval for meningitis B vaccine, Bexsero

Basel, June 17, 2014 – Novartis announced today the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for marketing approval for the use of Bexsero® (Multicomponent More...

By The Dispatch On Friday, June 6th, 2014
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Eloctate, Antihemophilic Factor receives FDA approval for treatment of Hemophilia A

The U.S. Food and Drug Administration today approved Eloctate, Antihemophilic Factor (Recombinant), Fc fusion protein, for use in adults and children who have Hemophilia A. Eloctate is the first Hemophilia A treatment More...

By The Dispatch On Friday, May 30th, 2014
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Celebrex generics receive FDA approval for RA treatment

PRESS RELEASE The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and More...

By The Dispatch On Wednesday, May 21st, 2014
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Molecular blood typing assay receives FDA approval

PRESS RELEASE The U.S. Food and Drug Administration today approved the Immucor PreciseType Human Erythrocyte Antigen (HEA) Molecular BeadChip Test – the first FDA-approved molecular assay used in transfusion medicine More...

By The Dispatch On Wednesday, May 21st, 2014
2 Comments

Entyvio receives FDA approval for the treatment of ulcerative colitis and Crohn’s disease

The U.S. Food and Drug Administration Tuesday approved Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn’s disease.Entyvio More...

By The Dispatch On Thursday, May 8th, 2014
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Zontivity tablets, to reduce heart attacks and strokes, gets FDA approval

PRESS RELEASE   The U.S. Food and Drug Administration today approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood More...

By The Dispatch On Tuesday, April 29th, 2014
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Lung cancer drug, Zykadia, receives accelerated FDA approval

PRESS RELEASE The U.S. Food and Drug Administration today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC). Zykadia More...

By The Dispatch On Wednesday, April 23rd, 2014
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Castleman’s disease drug, Sylvant, gets FDA approval

The U.S. Food and Drug Administration today approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes). MCD causes More...

By The Dispatch On Monday, April 21st, 2014
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Stomach cancer drug, Cyramza, receives FDA approval

PRESS RELEASE The U.S. Food and Drug Administration today approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the More...

By The Dispatch On Wednesday, April 16th, 2014
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Diabetes drug, Tanzeum, receives FDA approval

PRESS RELEASE The U.S. Food and Drug Administration Tuesday approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Type More...

By The Dispatch On Thursday, April 3rd, 2014
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Evzio, for reversing opioid overdose, gets FDA approval

PRESS RELEASE The U.S. Food and Drug Administration today approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio More...

By Robert On Friday, March 28th, 2014
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Janssen Pharmaceuticals, Topamax, for migraine prevention gets FDA nod

PRESS RELEASE Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug More...

By The Dispatch On Friday, March 21st, 2014
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Celgene’s Otezla receive FDA approval for treating psoriatic arthritis

PRESS RELEASE The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA). PsA is a form of arthritis that affects some people with psoriasis. Most More...


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