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 The leading web portal for pharmacy resources, news, education and careers January 27, 2015
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - January 27, 2015

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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1/26/15 - Octapharma USA Announces FDA Approval for 2nd Octagam 10% Manufacturing Site, Expanding Product Availability
Octapharma USA today announced that the U.S. Food and Drug Administration has approved the company s manufacturing facility in Vienna, Austria for the production of Octagam 10%, which became available in the U.S. during October 2014. Octapharma USA today announced that the U.S. Food and Drug Administration has approved the company's manufacturin
1/26/15 - Symplmed Announces FDA Approval of Prestalia for Treatment of Hypertension
CINCINNATI& BEND, Ore. Symplmed Pharmaceuticals today announced that the U.S. Food and Drug Administration has approved Prestalia tablets, licensed from Servier, for the treatment of hypertension. This is a significant milestone for Symplmed and for our development partner Servier as it is the first product from our perindopril pipeline t
1/26/15 - Teva Receives FDA Approval for First Generic NexiumDelayed-Release Capsulesin the United States
Teva Pharmaceutical Industries Ltd. announces the Food and Drug Administration approval of the first generic equivalent to Nexium Delayed-Release Capsules in the United States. Teva is preparing to launch the product in the near future. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more
1/26/15 - TOS: FDA Approves First Medical Device for Obesity Treatment Targeting Brain-to-Stomach Signaling
"This is a novel device that interrupts signals from the stomach to the brain that are believed to be involved with stomach emptying and feelings of fullness," said Martin Binks, PhD, FTOS, Secretary/Treasurer of The Obesity Society and Associate Professor of Nutritional Sciences at Texas Tech University. "In clinical trials the device resulted in
1/26/15 - U.S. FDA Approves Rockwell's Triferic(TM) for Iron Replacement and Maintenance of Hemoglobin in Hemodialysis Patients
Rockwell Medical, Inc., a fully-integrated biopharmaceutical company targeting end-stage renal disease and chronic kidney disease with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that the U.S. Food& Drug Administration has approved its drug Triferic for...
1/25/15 - Novartis Bexsero vaccine approved by FDA for the prevention of meningitis B, the leading cause of bacterial meningitis in the US
NOVARTIS FINANCE S.A./ Novartis Bexsero vaccine approved by FDA for the prevention of meningitis B, the leading cause of bacterial meningitis in the US. Basel, January 23, 2015- Novartis announced today that the US Food and Drug Administration has granted accelerated approval of Bexsero for active immunization to prevent invasive meningococcal d
1/24/15 - FDA Approves Natpara (parathyroid hormone) for Injection as an Adjunct to Calcium and Vitamin D to Control Hypocalcemia in Patients with Hypoparathyroidism
NPS Pharmaceuticals, Inc., a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced that the U.S. Food and Drug Administration has approved Natpara as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.
1/24/15 - Signostics Secures FDA 510k Clearance for Handheld Bladder Scanner [Professional Services Close - Up]
Signostics has received clearance from the U.S. Food and Drug Administration to launch the SignosRT Bladder, the company's new hand-held bladder scanner. The product is already sold in Australia and New Zealand with applications across a number of medical sectors including aged care, home nursing, midwifery, urology and palliative care.
1/24/15 - Switzerland : Novartis Bexsero vaccine approved by FDA for the prevention of meningitis B, the leading cause of bacterial meningitis in the US [TendersInfo (India)]
Novartis announced today that the US Food and Drug Administration has granted accelerated approval of Bexsero for active immunization to prevent invasive meningococcal disease caused by serogroup B in adolescents and young adults from 10 years through 25 years of age. As part of the accelerated approval process, Novartis will complete its ongoing..
1/24/15 - United States : FDA approves a second vaccine to prevent serogroup B meningococcal disease [TendersInfo (India)]
The U.S. Food and Drug Administration today approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Bexsero is the second vaccine approved by the FDA in the past three months to prevent this disease. With today s approval of Bexsero, the U.S. now h
1/24/15 - United States : FDA approves Natpara to control low blood calcium levels in patients with hypoparathyroidism [TendersInfo (India)]
The U.S. Food and Drug Administration today approved Natpara to control hypocalcemia in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 people in the United States. The FDA granted Natpara orphan drug designation because it is intended to treat a rare disease. People with hypoparathyroidism have limited treatment.
1/24/15 - United States : Medtronic Introduces Enhanced Therapy to Treat Debilitating Symptoms of Serious Stomach Disorder [TendersInfo (India)]
Medtronic, Inc. today announced it has received United States Food and Drug Administration approval, under a humanitarian device exemption*, for the Medtronic Enterra II System. The system is used to treat chronic, intractable nausea and vomiting associated with gastroparesis of diabetic or unknown origin when more conservative treatments fail o
1/23/15 - ADVAXIS, INC. FILES (8-K) Disclosing Regulation FD Disclosure, Other Events
A copy of the press release of Advaxis, Inc. dated January 22, 2015 relating to the announcement discussed in Item 8.01 below is attached hereto as Exhibit 99.1. On January 22, 2015, the Company announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application to conduct a Phase 1 b clinical study of ADXS-HER
1/23/15 - Astellas Announces FDA Anti-Infective Drugs Advisory Committee Recommends Approval of CRESEMBA (isavuconazonium) for Treatment of Invasive Aspergillosis and Mucormycosis
Release date- 23012015- NORTHBROOK, Ill.,- Astellas today announced that the U.S. Food and Drug Administration's Anti-infective Drugs Advisory Committee voted unanimously to recommend approval of the investigational once-daily intravenous and oral broad-spectrum CRESEMBA for the treatment of invasive aspergillosis, and 8 to 2 with one abstention to
1/23/15 - Basilea announces that FDA's Anti-Infective Drugs Advisory Committee recommends approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis
Basilea's partner Astellas presented the data to the FDA and, if approved, intends to market the drug as Cresemba in the United States. 'The Advisory Committee's positive vote is an important regulatory step in the ongoing FDA review of isavuconazole,' said Ronald Scott, Basilea's Chief Executive Officer. The FDA is not bound by the Advisory Commit
1/23/15 - FDA approves 2nd vaccine against meningitis strain
WASHINGTON Federal health regulators have approved a second vaccine to prevent a strain of bacteria that can cause deadly cases of meningitis. The Food and Drug Administration said it cleared Novartis' Bexsero vaccine against a subtype of meningococcal bacteria in people ages 10 to 25. The agency cleared a similar vaccine from Pfizer last Octobe
1/23/15 - FDA Approves MED-EL's SYNCHRONY Cochlear Implant
MED-EL USA announced today that the U.S. Food and Drug Administration has approved the new SYNCHRONY cochlear implant. MED-EL USA announces the FDA approval of the SYNCHRONY cochlear implant. MED-EL has continued its unprecedented advancement in the area of cochlear implant and MRI safety, said Raymond Gamble, President& CEO, MED-EL North Ame
1/23/15 - GNW-News: Novartis Bexsero vaccine approved by FDA for the prevention of meningitis B, the leading cause of bacterial meningitis in the US (english)
Novartis Bexsero vaccine approved by FDA for the prevention of meningitis B, the leading cause of bacterial meningitis in the US. Novartis International AG/ Novartis Bexsero vaccine approved by FDA for the prevention of meningitis B, the leading cause of bacterial meningitis in the US. approval in Europe, over 1 million doses have been distri
1/23/15 - Medtronic Introduces Enhanced Therapy to Treat Debilitating Symptoms of Serious Stomach Disorder
FDA-Approved System May Provide Long-Term Symptom Relief for Patients Suffering from Gastroparesis MINNEAPOLIS- January 23, 2015- Medtronic, Inc. today announced it has received United States Food and Drug Administration approval, under a humanitarian device exemption, for the Medtronic Enterra II System. The system is used to treat chronic, intrac
1/23/15 - Novartis Bexsero vaccine approved by FDA for the prevention of meningitis B, the leading cause of bacterial meningitis in the US
BASEL, Switzerland, Jan. 23, 2015/ PRNewswire/ Novartis announced today that the US Food and Drug Administration has granted accelerated approval of Bexsero for active immunization to prevent invasive meningococcal disease caused by serogroup B in adolescents and young adults from 10 years through 25 years of age. "While rare, meningitis B is
1/23/15 - Switzerland : Novartis announces FDA approval for first IL-17A antagonist Cosentyx(TM) (secukinumab) for moderate-to-severe plaque psoriasis patients [TendersInfo (India)]
Novartis today announced the US Food and Drug Administration has approved Cosentyx (TM) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. "The FDA's approval of Cosentyx signifies a turning point for psoriasis patients, who can now benefit from the first and only app
1/23/15 - The National Meningitis Association (NMA) Applauds FDA Approval of Second Vaccine To Protect Against Serogroup B Meningococcal Disease
Today the U.S. Food and Drug Administration announced the approval of Novartis' Bexsero for the prevention of serogroup B meningococcal disease in individuals ages 10 to 25. Bexsero and Pfizer's vaccine Trumenba , which received FDA approval in October, represent a significant step forward in helping prevent this devastating disease.
1/23/15 - US approves 2nd vaccine against meningitis strain
WASHINGTON U.S. government health regulators have approved a second vaccine to prevent a strain of bacteria that can cause deadly cases of meningitis. The Food and Drug Administration said it cleared Novartis' Bexsero vaccine against a subtype of meningococcal bacteria in people ages 10 to 25. The agency cleared a similar vaccine from Pfizer las
1/22/15 - Advaxis Announces FDA Acceptance of Its Investigational New Drug Application to Commence First-in-Human Clinical Trials of ADXS-HER2
Advaxis, Inc., a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application to conduct a Phase 1 clinical study of ADXS-HER2 for the treatment of patients with metastatic HER2 expressing solid tumors. The clinical trial, wh
1/22/15 - Astellas Announces FDA Anti-Infective Drugs Advisory Committee Recommends Approval of CRESEMBA (isavuconazonium) for Treatment of Invasive Aspergillosis and Mucormycosis
"We look forward to working with the FDA to bring this important new therapy to patients to address an unmet need in the treatment of these life-threatening infections." The Advisory Committee provides the FDA with independent expert advice and recommendations. The FDA is not bound by the committee's guidance, but its input will be considered by th
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