Pluristem Therapeutics today announced that the FDA has reviewed its PLacental eXpanded (PLX) cell products and granted approval for the company to manufacture them in its new commercial-scale cell manufacturing facility.
Endo Pharmaceuticals has received FDA approval of AVEED (testosterone undecanoate) injection for...
Teva Pharmaceutical has announced the approval of the generic equivalent to Evista® (Raloxifene...
The FDA has approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy.
Iroko Pharmaceuticals, LLC, has announced that the FDA has approved TIVORBEX™ (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20 mg and 40 mg doses for the treatment of mild to moderate acute pain in adults.
Vertex Pharmaceuticals today announced the FDA approved a supplemental New Drug Application (sNDA) for KALYDECO (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have one of eight additional mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
The FDA has approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure.
Shire has announced that the FDA has approved the production of VPRIV drug substance (velaglucerase alfa for injection) in Shire's manufacturing facility in Lexington, Massachusetts. The facility was previously approved by the European Medicines Agency (EMA) for production of VPRIV drug substance.
The FDA has expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.
Genzyme has announced that Mexico’s national regulatory authority, COFEPRIS, has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing remitting forms of multiple sclerosis (MS) to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations.
WHITEHOUSE STATION, N.J. (AP) — Merck & Co. says it's won its first approval for its new immunotherapy tablet for grass allergies, from regulators in Canada. The drug, called Grastek, gradually reduced allergic reactions to grass pollen, by desensitizing the immune system to the substance triggering the allergic reaction.
Biogen Idec said Monday it will launch its new multiple sclerosis drug Tecfidera in Europe in the coming weeks following approval by the European Commission. The European Union regulatory agency cleared the once-a-day pill for patients with relapsing multiple sclerosis, the most common form of the immune disease in which the body attacks the brain and spinal cord.
The FDA approved Hetlioz capsules for patients who have problems sleeping because they can't detect light. The condition, called non-24-hour disorder, is estimated to affect up to 100,000 Americans, most of whom are totally blind.
Valeant Pharmaceuticals International, Inc. announced today that it has received approval from the Food and Drug Administration (FDA) for its Supplemental New Drug Application (sNDA) for Retin-A Micro (tretinoin) Gel microsphere 0.08% for the topical treatment of acne vulgaris.
AstraZeneca and Bristol-Myers Squibb today announced that Xigduo™ (dapagliflozin and metformin hydrochloride in 5mg/850mg and 5mg/1000mg tablets) has been granted Marketing Authorization by the European Commission for the treatment of type 2 diabetes in the European Union (EU).
The Food and Drug Administration has cleared a first-of-a-kind blood test that can help predict intellectual disabilities in infants by analyzing their genetic code. The laboratory test from Affymetrix detects variations in patients' chromosomes that are linked to Down syndrome, DiGeorge syndrome and other developmental disorders.
The FDA has approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (cannot be removed by surgery) or metastatic (late-stage). In May 2013, the FDA approved both drugs as single agents to treat patients with unresectable or metastatic melanoma.
The U.S. Food and Drug Administration has approved the first gel sealant for use in stopping fluid from leaking through the incision in a patient’s cornea after cataract surgery with intraocular lens placement in adults.
Actavis has received approval from the FDA on its Abbreviated New Drug Application (ANDA) for Telmisartan Immediate-Release Tablets, 20 mg, 40 mg and 80 mg, a generic equivalent to Boehringer Ingelheim's Micardis. Actavis intends to launch the product immediately.
The U.S. Food and Drug Administration has approved a new diabetes drug from Bristol-Myers Squibb and AstraZeneca that uses a novel approach to reduce blood sugar. Farxiga is a once-a-day tablet designed to help diabetes patients eliminate excess sugar via their urine. That differs from older...
The Food and Drug Administration approved 27 first-of-a-kind drugs in 2013, down from 39 new medications in 2012, which was a 15-year high. Despite the decline, FDA officials say the tally of innovative medications approved last year is in line with the historical trend. On average, the FDA has approved 28 first-of-a-kind drugs annually over the past five years.
The Food and Drug Administration has approved a new once-a-day inhaler from GlaxoSmithKline PLC that combines two drugs to treat lung disease.
The drug Sovaldi (sofosbuvir) is to be taken in combination with older medications to treat the main forms of hepatitis C, which is caused by a blood-borne virus. Left untreated, the disease can lead to liver failure, cirrhosis and cancer.
Cambrex Corporation announced that the US Food and Drug Administration (FDA) completed an inspection of Cambrex's active pharmaceutical ingredient (API) manufacturing facility in Charles City, Iowa. The inspection found the site to be compliant with the principles and guidelines of Good Manufacturing Practice (GMP) and no Form 483 observations were issued
Gilead Sciences has announced that the FDA has approved the single tablet HIV-1 regimen Complera ® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for use in certain virologically-suppressed (HIV RNA <50 copies/mL) adult patients on a stable antiretroviral regimen in order to replace their current antiretroviral treatment regimen
A panel of federal health advisers has overwhelmingly backed the benefits of an experimental diabetes drug that uses a new method to reduce blood sugar, setting aside previous concerns about the pill's safety. The Food and Drug Administration panel voted 13-1 on Thursday in favor of the drug from...
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 Lymphoseek® (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer.
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