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 The leading web portal for pharmacy resources, news, education and careers September 26, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - September 26, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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8/26/17 - Adamas Pharma given FDA approval for Parkinsons Drug [T-break Tech (Middle East)]
Adamas Pharmaceuticals Inc. received approval from the FDA for its drug GOCOVRI. Prior to the approval of the drug, the FDA had not approved of any drugs to treat Dyskinesia. This FDA approval puts Adamas in a very secured spot for the drug as it faces zero competition, according to SeekingAlpha.
8/26/17 - Biogen, Samsung Humira copy wins EU approval [Arab Finance (Egypt)]
The forces of competition are mounting against Humira, the worlds best-selling drug at $16 billion in global sales, with approval of a second biosimilar in Europe. AbbVie gets about 60% of its revenues from Humira, which last year recorded $10.4 billion in U.S. sales, up 24%, and $5.6 billion in the rest of the world, up 4%. Even though Amgens Amje
8/26/17 - FDA Approves Diabetes Drug Indication to Reduce CV Risk [Syrian Arab News Agency]
Officials with the FDA have approved a new indication for liraglutide, making it the only type 2 diabetes drug indicated to reduce the risk of major adverse cardiovascular events in adults, according to a press release from Novo. The approved indication is based on results from a clinical trial demonstrating that Victoza significantly reduced the r
8/26/17 - US OKs first drug for dyskinaesia in Parkinsons patients [Arab Finance (Egypt)]
The US Food and Drug Administration has cleared Adamas Pharmaceuticals Gocovri extended release capsules for dyskinesia in Parkinsons disease patients receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Dyskinesia is a consequence of levodopa-based Parkinsons disease treatment that affects around 90 percent...
8/25/17 - 22 Stocks Moving In Friday's Pre-Market Session
Gainers Adamas Pharmaceuticals Inc shares rose 56.2 percent to $22.23 in pre-market trading following announcement of the FDA approval of GOCOVRI. Kamada Ltd gained 25.6 percent to $5.40. Kedrion Biopharma and Kamada received FDA approval of KEDRAB for post-exposure prophylaxis against rabies infection. XOMA Corporation rose 22.1 percent to $10.90
8/25/17 - Medizone International Announces Next Steps with FDA on AsepticSure
The FDA recommended that the Company proceed to market through the de novo classification pathway given its novel technology compared to other FDA- regulated disinfection systems. In November 2016, Medizone received clearance from the U.S. Environmental Protection Agency to market AsepticSure ozone disinfectant formula for use for disinfection of..
8/25/17 - Octapharma USA Announces FDA Approval Of NUWIQ New Product Strengths, Expanding Hemophilia A Patient Treatment Options [T-break Tech (Middle East)]
Octapharma USA recently announced the U.S. Food and Drug Administration has approved new product strengths for NUWIQ, offering added convenience by potentially reducing the number of vials needed for Hemophilia A patients. The agency approved new single dose NUWIQ vial strengths of 2500, 3000 and 4000 International Units, which will be available fo
8/25/17 - Titan Pharma (TTNP) Says It was Cleared by FDA to Begin Clinical Study of Parkinson`s Disease Treatment [Sport360]
Titan Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has cleared the Investigational New Drug application for its ropinirole implant intended for treatment of the signs and symptoms of Parkinson`s disease. Aaron Ellenbogen of the Michigan Institute of Neurological Disorders, and the principal investigator at the fi
8/25/17 - Titan Pharmaceuticals Receives FDA Clearance to Begin Clinical Study of Parkinson's Disease Treatment
Release date- 24082017- SOUTH SAN FRANCISCO, Calif.- Titan Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has cleared the Investigational New Drug application for its ropinirole implant intended for treatment of the signs and symptoms of Parkinson's disease. Aaron Ellenbogen of the Michigan Institute of Neurologica
8/25/17 - Titan Pharmaceuticals Receives FDA Clearance To Begin Clinical Study of Ropinirole Implant for Parkinson's Disease
Titan Pharmaceuticals Inc announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its ropinirole implant intended for treatment of the signs and symptoms of Parkinson's disease.
8/25/17 - USFDA OKAYS MARKETING OF CADILA'S HYPERTENSION DRUG
The US Food and Drug Administration has given its final approval to Zydus Cadila to market its anti-hypertension drug, candesartan cilexetil, in USA. Zydus has got approval for selling the tablets in the strengths of 4 mg, 8 mg, 16 mg and 32 mg.
8/25/17 - Victoza (liraglutide) is approved in the US as the only type 2 diabetes treatment indicated to reduce the risk of three major adverse cardiovascular events
The U.S. Food and Drug Administration has approved a new indication for Victoza to reduce the risk of major adverse cardiovascular events, heart attack, stroke and CV death, in adults with type 2 diabetes and established CV disease. 1. "Physicians have come to rely on Victoza as an effective therapy for lowering A1C, and with this new indi
8/25/17 - Victoza approved in the US as the only type 2 diabetes treatment indicated to reduce the risk of major adverse cardiovascular events
Bagsvrd, Denmark, 25 August 2017- The U.S. Food and Drug Administration has approved a new indication for Victoza to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established CV disease. The FDA's decision is based on the results from the landmark LEADER trial, which demonstrated that Victoza statistica
8/24/17 - Adamas Announces FDA Approval of GOCOVRI? as First and Only Medication for the Treatment of Dyskinesia in Parkinson's Disease Patients
Adamas Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has approved GOCOVRI extended release capsules for treatment of dyskinesia in patients with Parkinson s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI, previously granted orphan drug status by the FDA
8/24/17 - Apeaz? is an FDA drug with approved claims for the pain relief of the following conditions:
Apeaz? is an FDA drug with approved claims for the pain relief of the following conditions:.
8/24/17 - AUM Cardiovascular Receives FDA Approval For Revolutionary Diagnostic Heart Device
By a News Reporter-Staff News Editor at Politics& Government Business AUM Cardiovascular announced that it has received clearance from the Food and Drug Administration for CADence,? a non-invasive acoustic and ECG device designed to help physicians detect physiological and pathological heart murmurs. The reusable, non-invasive, radiation-free..
8/24/17 - NetworkNewsBreaks Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) Obtains FDA Clearance to Commence Clinical Study of Parkinson's Disease Treatment
Shares of Titan Pharmaceuticals are 5% higher after the company this morning said its Investigational New Drug application for its ropinirole implant has been cleared by the U.S. Food and Drug Administration. Titan Pharmaceuticals Inc., based in South San Francisco, CA, is developing proprietary therapeutics primarily for the treatment of serious m
8/24/17 - Octapharma USA Announces FDA Approval of NUWIQ New Product Strengths, Expanding Hemophilia A Patient Treatment Options
Release date- 23082017- HOBOKEN, N.J.- Octapharma USA today announced the U.S. Food and Drug Administration has approved new product strengths for NUWIQ, offering added convenience by potentially reducing the number of vials needed for Hemophilia A patients. 'The new vial options will benefit patients, physicians and healthcare professionals by pro
8/24/17 - Pharma Major Lupin Limited - Lupin launches generic Seroquel XR tablets in the US
Release date- 23082017- Mumbai, Baltimore- Pharma Major Lupin Limited announced the launch of its Quetiapine Fumarate Extended Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg having received an approval from the United States Food and Drug Administration earlier. Lupin's Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg,
8/24/17 - Titan Pharmaceuticals Receives FDA Clearance To Begin Clinical Study Of Parkinson's Disease Treatment
Titan Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has cleared the Investigational New Drug application for its ropinirole implant intended for treatment of the signs and symptoms of Parkinson's disease. Aaron Ellenbogen of the Michigan Institute of Neurological Disorders, and the principal investigator at the
8/23/17 - Alexion`s (ALXN) Soliris` Label Expansion Approved in Europe [Arab Times (Kuwait)]
ALXN announced that the European Commission approved a label expansion of lead drug Soliris. The European Commission expanded the indication for Soliris to include the treatment of refractory generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody-positive. The FDA accepted the supplemental Biologics License...
8/23/17 - BESPONSA (inotuzumab Ozogamicin) Approved for Treatment of Adult Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia, Available for Order at Biologics, Inc.
Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, announced today it has been selected by Pfizer, Inc. to be a specialty pharmacy provider for BESPONSA, a promising new IV therapy for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Approved by the U.S. Food and Drug Administra
8/23/17 - FDA Approves Combo Treatment for Uncontrolled Gout [Sport360]
The FDA has approved a novel fixed-dose combination therapy indicated to treat hyperuricemia in patients with uncontrolled gout. Duzallo, manufactured by Ironwood Pharmaceuticals, is a once-daily combination of lesinurad and allopurinol designed to achieve target serum uric acid levels in patients who cannot do so with allopurinol alone.
8/23/17 - FDA Approves IRWD`s Gout Drug, It`s A Thumbs Up For ALXN In EU, CRME Crushed [Arab Finance (Egypt)]
Today`s Daily Dose brings you news about European approval of Alexion`s Soliris for an additional indication; Alkermes` New Drug Application for a major depressive disorder drug; Astellas` MORPHO trial progress; Axovant`s move to NASDAQ from the Big Board; Cardiome`s disappointing update related to its antiarrhythmic drug and FDA approval of Ironwo
8/23/17 - FDA Approves Perrigo Company plc. (NYSE:PRGO) Generic Version of AstraZeneca plc. (ADR)(NYSE:AZN) Nexium
The Food and Drug Administration has granted Perrigo Company plc. Ordinary Shares (NYSE:PRGO) the green light to sell its over the counter version of AstraZeneca plc. (ADR)(NYSE:AZN) Nexium 24hr capsules. The approval according to executive vice president, Jeff Needham, affirms the company's tremendous capabilities in the store brand OTC platform
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