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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
