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 The leading web portal for pharmacy resources, news, education and careers August 19, 2018
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - August 19, 2018

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 82     Next >>     Go To Page:

8/19/18 - FDA approves Teva's generic of Mylan's EpiPen [Jerusalem Post (Israel)]
The US Food and Drug Administration has approved Teva Pharmaceutical Industries Ltd. s generic version of Mylan NV s life-saving allergy injection, EpiPen, at a time when regulators are looking to lower healthcare costs. There has also been a shortage of EpiPen in North America, Europe and Canada since earlier this year due to manufacturing d
8/18/18 - Albumin (As Excipient) Market to Reach US$ 1200 Mn by 2019
Albany, NY 08/18/2018 Global Albumin Market Snapshots. The global albumin market was valued at US$ 750 Mn in 2017 and is anticipated to reach US$ 1200 Mn by 2026 at a CAGR of over 5.0% from 2018 to 2026. For instance, in May 2017, China's Food and Drug Administration granted approval to clinical trials of human blood albumin produced from
8/18/18 - FDA approves first generic competitor to EpiPen [T-break Tech (Middle East)]
It was approved after the FDA issued new guidance for generic copies of products like the EpiPen, which combines a drug with a specialized device to deliver it fast when people have life-threatening allergic reactions. This approval means patients living with severe allergies who require constant access to lifesaving epinephrine should have a lower
8/18/18 - FDA Clears SPR Therapeutics Non-opioid SPRINT endura and extensa Peripheral Nerve Stimulation Systems for Pain Management [Tehran Times (Iran)]
SPR Therapeutics, Inc., a leader in neurostimulation technology for pain, today announced that the U.S. Food and Drug Administration has cleared its SPRINTendura and extensa Peripheral Nerve Stimulation Systems. With the ease of use and dual lead capabilities weve built into the SPRINT System we look forward to advancing the early use of neurostimu
8/18/18 - KALYDECO approved as first CF drug in children under 24 months [Syrian Arab News Agency]
Vertex Pharmaceuticals Incorporated has announced the U.S. Food and Drug Administration approved KALYDECO to include use in children with cystic fibrosis ages 12 to.
8/17/18 - Alnylam Announces First-Ever FDA Approval of an RNAi Therapeutic, ONPATTRO for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults
CAMBRIDGE- Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced today that the United States Food and Drug Administration approved ONPATTRO lipid complex injection, a first-of-its-kind RNA interference therapeutic, for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
8/17/18 - Amicus Therapeutics - FDA Approves Galafold for the Treatment of Certain Adult Patients with Fabry Disease
CRANBURY- Amicus Therapeutics today announced that the U.S. Food and Drug Administration has granted accelerated approval of Galafold 123 mg capsules. As a condition of accelerated approval, Amicus Therapeutics will continue to study Galafold in a confirmatory Phase 4 program. John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeu
8/17/18 - Antares Pharma Announces FDA Approval of Generic EpiPen Utilizing VIBEX Auto Injector
Antares Pharma announced that the U.S. Food and Drug Administration has approved Teva Pharmaceutical, epinephrine auto injector drug-device combination product indicated for emergency treatment of severe allergic reactions including those that are life threatening in adults and certain pediatric patients. We are extremely pleased with the FDA
8/17/18 - Bristol-Myers Squibb Says FDA Approves Opdivo
NEW YORK CITY- Bristol-Myers Squibb Co. said that Opdivo received approval from the U.S. Food and Drug Administration as the first and only Immuno-Oncology treatment option for patients with metastatic small cell lung cancer whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indic
8/17/18 - Cipla Receives Final Approval for Generic Reyataz
Mumbai- Cipla Limited today announced that it has received final approval for its Abbreviated New Drug Application for Atazanavir Caps 100 mg, 150 mg, 200 mg, 300 mg from the United States Food and Drug Administration. Cipla's Atazanavir Caps 100 mg, 150 mg, 200 mg, 300 mg is AB-rated generic therapeutic equivalent version of Bristol-Myers Squibb P
8/17/18 - FDA Approves EYLEA (aflibercept) Injection sBLA in Wet Age-related Macular Degeneration
Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for EYLEA Injection in patients with wet age-related macular degeneration. "We are pleased that the FDA has approved an updated label for EYLEA," said George D. Yancopoulos, M.D., Ph.D., Presiden
8/17/18 - FDA Approves First Generic Version of EpiPen
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening, in adults and pediatric
8/17/18 - FDA approves first generic version of lifesaving EpiPen
FDA Commissioner Scott Gottlieb, insurers and advocates said the copycat device from Teva Pharmaceuticals, an Israeli company, could be a lifeline for patients looking to save money and access vital medication, after Mylan reported supply shortages with its manufacturing partner, Pfizer. Under pressure from Congress, Mylan didn't slash prices, but
8/17/18 - FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease
The U.S. Food and Drug Administration today approved Onpattro infusion for the treatment of peripheral nerve disease caused by hereditary transthyretin-mediated amyloidosis in adult patients. This is the first FDA- approved treatment for patients with polyneuropathy caused by hATTR, a rare, debilitating and often fatal genetic disease characterized
8/17/18 - FDA OKs Teva product as 1st generic version of EpiPen
WASHINGTON- The Food and Drug Administration approved the first generic version of EpiPen on Thursday, a move that will bring new competition for the lifesaving allergy injection that helped spark public furor over high drug prices. There has been "limited availability of EpiPen in certain areas in the U.S., including both pharmacy-level supply dis
8/17/18 - GI DYNAMICS, INC. FILES (8-K) Disclosing Other Events, Financial Statements and Exhibits
On August 13, 2018, GI Dynamics, Inc. announced that it had received approval of an investigational device exemption from the U.S. Food and Drug Administration to begin enrollment in a pivotal trial evaluating the safety and efficacy of EndoBarrier in the United States pending Institutional Review Board approval. A copy of the press release announc
8/17/18 - New Drugs Approved In July
The FDA approved SIGA Technologies Inc.' s oral TPOXX, also known as Tecovirimat and ST-246, for the treatment of smallpox on July 13. Only two labs in the world have been permitted to store the smallpox virus for research- the Centers for Disease Control and Prevention in the United States, and the Russian State Centre for Research on Virology and
8/17/18 - New Peptide Hormones Study Findings Have Been Reported from Emory University (Angiotensin II : a new therapeutic option for vasodilatory shock)
According to news reporting originating in Atlanta, Georgia, by NewsRx journalists, research stated, "Angiotensin II, part of the renin-angiotensin-aldosterone system, is a potent vasoconstrictor and has been recently approved for use by the US Food and Drug Administration in high-output shock. The news reporters obtained a quote from the research
8/17/18 - Regeneron Pharma: FDA Okays EYLEA Injection SBLA In Wet AMD
WASHINGTON- Regeneron Pharmaceuticals, Inc. said that the U.S. Food and Drug Administration or FDA has approved a supplemental Biologics License Application or sBLA for Eylea Injection in patients with wet age-related macular degeneration or wet AMD. The sBLA was based on second-year data from the Phase 3 VIEW 1 and 2 trials in which patients with
8/17/18 - Teva wins FDA nod for EpiPen
U.S. regulators cleared the first generic competitor to Mylan's EpiPen, after a lengthy delay that many said contributed to the emergency allergy drug's rapid rise in price. Teva Pharmaceuticals received Food and Drug Administration approval for generic versions of both the EpiPen and EpiPen Jr, the agency said in a statement Thursday.
8/17/18 - Therapy for rare cancers receives FDA approval following trials at Penn's Abramson Cancer
By a News Reporter-Staff News Editor at Health& Medicine Week PHILADELPHIA- The U.S. Food and Drug Administration has approved the first ever non-surgical treatment for the rare neuroendocrine cancers pheochromocytoma and paraganglioma. The approval was based on a multi-center trial led by researchers in the Abramson Cancer Center of the Universi
8/17/18 - U.S. Food and Drug Administration Approves Opdivo (nivolumab) as the First New Medication in Nearly 20 Years for Certain Patients with Previously Treated Small Cell Lung Cancer
Bristol-Myers Squibb Company today announced that Opdivo received approval from the U.S. Food and Drug Administration as the first and only Immuno-Oncology treatment option for patients with metastatic small cell lung cancer whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. 1 Approval for this...
8/16/18 - Antares Pharma Announces FDA Approval of Generic EpiPen Utilizing VIBEX Auto Injector
Antares Pharma, Inc. today announced that the U.S. Food and Drug Administration has approved Teva Pharmaceutical Industries, Ltd. s epinephrine auto injector drug-device combination product indicated for emergency treatment of severe allergic reactions including those that are life threatening in adults and certain pediatric patients.
8/16/18 - FDA approves first generic EpiPen
The U.S. Food and Drug Administration gave approval Thursday for the first generic version of EpiPen, an injection device to treat severe allergic reactions. "The path to developing generic drug-device combination products like this one is challenging," FDA Commissioner Scott Gottlieb said. Mylan and its CEO, Heather Bresch, were accused of price-
8/16/18 - FDA approves first generic version of EpiPen
The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening, in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrin
Articles(s): 1 - 25 of 82     Next >>     Go To Page:


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