The FDA has approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions.
Navidea Biopharmaceuticals announced today that the FDA has granted Fast Track designation to...
U.S. health officials have approved a highly anticipated hepatitis C drug from Gilead Sciences...
The Food and Drug Administration on Friday approved the first drug to treat an unusual condition...
AstraZeneca today announced that the European Commission (EC) has granted Marketing Authorization to FluenzTM Tetra. Fluenz Tetra is a nasally administered four-strain live attenuated influenza vaccine for the prevention of influenza in children and adolescents from 24 months up to 18 years of age
Immunomedics said today its cancer drug IMMU-132 will receive orphan drug incentives as a treatment for small cell lung cancer. The Morris Plains, N.J., company said IMMU-132 is in mid-stage testing as a treatment for small cell lung cancer and other types of solid tumors.
Specialty drugmaker BTG PLC has received U.S. approval to market an injectable drug to treat patients with varicose veins. The drug, Varithena, is pharmaceutical foam dispensed from a canister device.
Mylan has announced that its partner Biocon has received approval for a Mylan-Biocon trastuzumab product from the Drug Controller General of India. This is the first regulatory approval for a Mylan-Biocon developed biosimilar product. The product is a biosimilar to Roche's Herceptin, indicated for the treatment of HER2 overexpressing breast cancer.
The FDA has expanded approval of a Bayer drug to treat patients with thyroid cancer. Bayer's pill Nexavar is already approved to treat kidney cancer and liver cancer that cannot be surgically removed. Now the FDA has approved the drug to treat cancerous growth of the thyroid gland, which is located in the neck.
The U.S. government has for the first time approved an adjuvanted vaccine to protect against H5N1 bird flu. The vaccine was made by Quebec City-based ID Biomedical, a subsidiary of pharmaceutical giant GlaxoSmithKline.
Federal regulators on Friday approved a new drug from Johnson & Johnson for use in treating chronic hepatitis C infections. The U.S. Food and Drug Administration said it approved the drug, a protease inhibitor that blocks a protein needed by the virus to replicate.
Pfizer has announced that the FDA has granted XALKORI ® (crizotinib) regular approval for the treatment of patients with metastatic ALK-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
BioMarin Pharmaceutical Inc. said Tuesday that a U.S. Food and Drug Administration advisory committee has voted in favor of its drug Vimizim for the treatment of Morquio A syndrome. Vimizim is designed to treat a rare disease called mucopolysaccharidosis Type IVA, or Morquio A Syndrome.
Valeant Pharmaceuticals said Friday that the Food and Drug Administration approved its Luzu cream, which is designed to treat fungal infections. The Canadian drugmaker said Luzu, or luliconazole, is intended to treat athlete's foot, jock itch, and ringworm. It said the cream is indicated for...
GW Pharmaceuticals announced today that the U.S. Food and Drug Administration has granted orphan drug designation for Epidiolex, which contains plant-derived Cannabidiol (CBD) as its active ingredient, for use in treating children with Dravet syndrome, a rare and severe form of infantile-onset, genetic, drug-resistant epilepsy syndrome.
The FDA has approved Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer. MCL is a rare form of non-Hodgkin lymphoma and represents about 6 percent of all non-Hodgkin lymphoma cases in the United States. By the time MCL is diagnosed, it usually has already spread to the lymph nodes, bone marrow and other organs.
An experimental cancer drug that has shown promise in the treatment of melanoma has also shown early potential as an effective treatment for patients with non-small cell lung cancer, the leading cause of cancer death among men and women worldwide.
The U.S. Food and Drug Administration has approved a stronger, single-ingredient version hydrocodone, the widely-abused prescription painkiller. The agency said Friday it approved the extended-release pill Zohydro ER for patients with pain that requires "daily, around-the-clock, long-term...
The FDA has approved Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer's disease (AD) and dementia.
UCB has announced hat the FDA has approved Cimzia (certolizumab pegol) for the treatment of adults with active ankylosing spondylitis (AS). The FDA also issued a Complete Response Letter relating to the supplemental Biologics License Application (sBLA) of Cimzia for the treatment of adults with active axial spondyloarthritis (axSpA).
Bayer HealthCare said Tuesday its drug Adempas has been approved as a treatment for two types of pulmonary hypertension, or high blood pressure in the arteries of the lungs. Bayer said it is already launching the drug, and called Adempas the first drug approved by the Food and Drug Administration...
Pfizer said Thursday the Food and Drug Administration approved its new hormone pill, Duavee, to treat hot flashes and osteoporosis associated with menopause. Regulators approved the drug for women who still have a uterus and are experiencing moderate to severe hot flashes.
Medivir AB has reported that Janssen Pharmaceutical R&D Ireland (Janssen) has been informed by the Japanese Ministry of Health, Labour and Welfare (MHLW) that simeprevir has been approved for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection.
Johnson & Johnson said Monday that the Food and Drug Administration expanded the approval of its psoriasis drug Stelara, allowing the company to market Stelara as a treatment for psoriatic arthritis in adults. Psoriatic arthritis is a form of arthritis that causes joint pain, stiffness and...
PCI Synthesis, a custom chemical manufacturer of new chemical entities (NCE), generic active pharmaceutical ingredients (API), and other specialty chemical products, announced the completion of the sixth inspection of the company's cGMP site in Newburyport, MA by the FDA.
Teva Pharmaceutical has announced that the FDA approved TREANDA (bendamustine HCI) Injection, a new formulation of the currently approved TREANDA (bendamustine HCI) for Injection.
Dr. Reddy’s Laboratories announced today that Azacitidine for Injection 100 mg/vial, a bioequivalent generic version of VIDAZA ® (azacitidine for injection), is approved by the United States Food & Drug Administration (USFDA) on September 16, 2013.
The FDA today approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic), and metastatic breast cancer. Teva Pharmaceuticals USA has gained FDA approval to market generic capecitabine in 150 and 500 milligram strengths.
Roche has announced that a new injectable (subcutaneous) formulation of Herceptin (trastuzumab) has been approved by the European Commission for the treatment of HER2-positive breast cancer, an aggressive sub-type of the disease. The approval is for both early and later stages of treatment.
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