BASEL- The U.S. Food and Drug Administration approved Opdivo or nivolumab to treat patients with advanced or metastatic renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy. Opdivo is marketed by Bristol-Myers Squibb based in Princeton, New Jersey. Torisel is marketed by Pfizer, based in New York, New Yor
Emergent BioSolutions Inc. today announced that the U.S. Food and Drug Administration approved its supplemental Biologics License Application to expand the label of BioThrax to include post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure when administered in conjunction with recommended...
FDA approves first seasonal influenza vaccine containing an adjuvant. The U.S. Food and Drug Administration today approved Fluad, the first seasonal influenza vaccine containing an adjuvant. "Fluad provides another alternative for a safe and effective influenza vaccine in people 65 years of age and older," said Karen Midthun, M.D., director of the
INDIANAPOLIS, Nov. 24, 2015/ PRNewswire/ Eli Lilly and Company announced today that the U.S. Food and Drug Administration has approved Portrazza?, in combination with gemcitabine and cisplatin, as the first biologic for the first-line treatment of people with metastatic squamous non-small cell lung cancer. Portrazza has been granted Orphan Drug
HAYWARD, Calif., No. 24, 2015/ PRNewswire/ Impax Laboratories, Inc. today announced that on November 20, the Company's development and manufacturing partner received final approval by the U.S. Food and Drug Administration for a generic version of dutasteride capsules, 0.5 mg. This is the 13 th generic product launched in 2015 by Impax's generic d
Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration has approved NINLARO capsules, the first and only oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Shkreli and other investors have committed to an equity investment of at least US $3 mln in KaloBios and additionally to a US $10 million equity financing facility. The company also elected David Moradi, Tony Chase, and Marek Biestek to its Board. The company's IND in CMML, an orphan oncology indication, has been cleared by the U.S. Food and Drug A
HERTFORDSHIRE, England and PITTSBURGH, Nov. 24, 2015/ PRNewswire/ Mylan N.V. today announced the U.S. launch of Clozapine Orally Disintegrating Tablets, 25 mg and 100 mg, the generic version of Jazz Pharmaceutical's FazaClo . Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for th
Vascular Solutions, Inc. today announced that it has received 510 clearance from the U.S. Food and Drug Administration for a new and enhanced version of the R350 guidewire, an extra-long guidewire designed for use in complex interventional procedures. Initial clinical evaluations of the new version of the R350 guidewire were performed in Canada, wh
RIVERVIEW, Mich., Nov., 23, 2015/ PRNewswire/ Ash Stevens, Inc., a leading provider of global contract pharmaceutical chemical development and API manufacturing services, is pleased to announce the U.S Food and Drug Administration has approved ASI's facility in Riverview, Michigan for the manufacture of the API ixazomib, an oral proteasome inhibi
Cumberland Pharmaceuticals Inc., a specialty pharmaceutical company focused on hospital acute care and gastroenterology announced the approval of Caldolor Injection for pediatric patients six months of age and older. The approval was based on data submitted to the U.S. Food and Drug Administration as part of a post-marketing commitment following
Entellus Medical, Inc., a medical technology company focused on delivering superior patient and physician experiences through products designed for the minimally invasive treatment of chronic and recurrent sinusitis patients, today announced the Company has received 510 clearance from the United States Food and Drug Administration for use of its.
Federal health regulators have expanded approval of a cancer drug from Bristol-Myers Squibb to treat an advanced form of kidney cancer. The Food and Drug Administration says the injectable-drug, Opdivo, is approved for patients with renal cell carcinoma who have previously tried certain other drugs. More than 14,000 U.S. patients are expected to
By a News Reporter-Staff News Editor at Clinical Trials Week Exelixis, Inc. announced that the U.S. Food and Drug Administration has approved COTELLIC? as a treatment for patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with vemurafenib. COTELLIC is a selective inhibitor of MEK that was disc
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration approved Pradaxa for the prophylaxis of deep venous thrombosis and pulmonary embolism in patients who have undergone hip replacement surgery. "This milestone represents the fourth FDA- approved indication for PRADAXA in five years a testam
FDA approves vaccine for use after known or suspected anthrax exposure. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure. "With today's approval of BioThrax, we now have a vaccine that can be used, together with antibiotic treatment, to prevent disease after exposure to an
Generon Corporation, a leading biotech company in China, announced today that the US FDA has cleared a phase IIa IND entitled An open-label, cohort dose escalating study to assess the safety and efficacy of F-652 in patients with alcoholic hepatitis. Vijay Shah, Chair, Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN. Generon had r
By a News Reporter-Staff News Editor at Cancer Vaccine Week AstraZeneca announced that the US Food and Drug Administration has approved TAGRISSO? 80 mg once-daily tablets for the treatment of patients with metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer, as detected by an FDA- approved test, who ha
Takeda submitted a New Drug Application for NINLARO to the FDA in July 2015, and in September NINLARO was granted Priority Review status with a PDUFA date of March 10, 2016, reflecting the profound and continuing unmet need for new treatments for multiple myeloma, a devastating, relapsing and incurable rare cancer. Since that time, we've significan
Aurobindo Pharma Ltd has secured the approval of US Food and Drug Administration for manufacturing and marketing tablets for treatment of high blood pressure. It would manufacture the generic version of Pfizer's Revatio 20 milligrams tablets. The product would be launched in US during Jan- Mar 2016.