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 The leading web portal for pharmacy resources, news, education and careers July 31, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - July 31, 2014

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 51     Next >>     Go To Page:

7/31/14 - Aflibercept Solution for Injection into the Eye Receives FDA Approval for the Treatment of Diabetic Macular Edema (DME)
Release date- 30072014- Berlin- The U.S. Food and Drug Administration has approved aflibercept solution for injection into the eye for the treatment of diabetic macular edema in the U.S. Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of EYLEA. Bayer HealthCare has licensed the exclusive marketing ri
7/31/14 - France Becomes 17th Country to Clear Cel-Sci for Phase 3 Cancer Trial; Regeneron and Sanofi Announce Plan For Alirocumab U.S. FDA Submission
In the past three months CEL-SCI has also received governmental clearance to expand its trial into the United Kingdom, Austria, Sri Lanka and Turkey. CEL-SCI s Phase III trial is assessing the Company s investigational immunotherapeutic agent Multikine as a potential first-line treatment for advanced primary head and neck cancer. The objectiv
7/31/14 - IGI Laboratories Reports 2Q Results [Professional Services Close - Up]
IGI Laboratories reported its financial results for the second quarter ended June 30. -IGI filed an additional ANDA, under a joint development agreement with Impax Laboratories, Inc. in June 2014. -IGI received its tentative approval from the FDA for an ANDA for diclofenac sodium 1.5 percent topical solution, and executed an agreement to enable the
7/31/14 - Pharmacyclics: U.S. FDA Grants Regular Approval for Imbruvica [Manufacturing Close - Up]
Pharmacyclics, Inc. reported that the U.S. Food and Drug Administration has granted Imbruvica regular approval for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17, including treatment naive and previously t
7/31/14 - Quidel Secures FDA Clearance for AmpliVue Gas Assay [Health & Beauty Close - Up]
Quidel Corp. reported that it has received clearance from the United States Food and Drug Administration to market its AmpliVue GAS Assay for the qualitative detection of Group A- hemolytic Streptococcus nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat.
7/30/14 - AcelRX Selling Off On FDA Reexamination; U.S. FDA Grants Approval for IMBRUVICA
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 28, 2014.{ nfg} Shares of AcelRx Pharmaceuticals are selling off sharply monday morning after a blow from the FDA to Zalviso. AcelRx made the announcement at an unusual time: 9:59 p.m. ET Friday. The FDA is looking for more information on how to u
7/30/14 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; FDA Safety Communication Readership Survey
SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled " FDA Safety Communication Readership Survey" has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 C
7/30/14 - Blue Belt Technologies Receives 510k Clearance for Patellofemoral Joint Replacement Application
By a News Reporter-Staff News Editor at Biotech Week Blue Belt Technologies has received FDA clearance to market their latest surgical application for the Navio Surgical System, patellofemoral joint replacement surgery. Smith and Nephew's patellofemoral joint system, Journey PFJ, will be the first implant system available for use with the Navi
7/30/14 - CorMatrix Gets FDA Approval to Market ECM for Vascular Repair [Professional Services Close - Up]
CorMatrix Cardiovascular reported that it has received U.S. Food and Drug Administration clearance to market the CorMatrix ECM for Vascular Repair. Richard F. Neville, Professor of Surgery, Chief, Division of Vascular Surgery at George Washington University said, "CorMatrix ECM for Vascular Repair is an innovative scaffold permitting the patient's
7/30/14 - FDA Confirms Approval of Gilead's Zydelig; FDA Approves Eagle Pharmaceuticals' Ryanodex
FDA said it has approved Gilead Sciences Inc's Zydelig, a drug to treat three types of blood cancer. The FDA approved the use of Zydelig in combination with Roche AG's Rituxan for patients with relapsed chronic lymphocytic leukemia. It also approved Zydelig under a so-called accelerated approval program for relapsed follicular B-cell non-Hodgkin ly
7/30/14 - IMBRUVICA (ibrutinib) Receives Regular Approval by U.S. FDA in Chronic Lymphocytic Leukemia (CLL) and CLL patients with del 17p
Release date- 29072014- HORSHAM, PA- The U.S. Food and Drug Administration has approved the supplemental New Drug Application for IMBRUVICA capsules for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy. CLL patients with del 17 p are considered to have the poorest prognosis. 2 IMBRUVICA is joi
7/30/14 - Purdue Pharma L.P. Receives FDA Approval for 7.5 mcg/hour Dosage Strength of Butrans Buprenorphine Transdermal System CIII
By a News Reporter-Staff News Editor at Biotech Week Purdue Pharma L.P. announced that the U.S. Food& Drug Administration approved a new 7.5 mcg/hour dosage strength of Butrans Transdermal System CIII. Purdue expects to launch Butrans 7.5 mcg/hour commercially in the United States in October 2014. "This approval provides healthcare professionals
7/30/14 - Review of ADHD drug approvals highlights gaps between approval process, long-term safety assessment
The study highlights gaps in how the long-term safety of drugs intended for chronic use in children is assessed as part of the FDA approval process. "Instead, we point to the need for an agenda emphasizing improved assessment of rare adverse events and long-term safety through post-marketing trials, comparative effectiveness trials and more active
7/30/14 - Trimel Provides Corporate Update and Second Quarter 2014 Financial Results
Trimel Pharmaceuticals Corporation today provided an overview of its corporate accomplishments and reported financial results for the three month period ended June 30, 2014. On May 28, 2014, the United States Food and Drug Administration approved Natesto?, for replacement therapy in adult males for conditions associated with a deficiency or absen
7/30/14 - United States : FDA expands approved use of Imbruvica for chronic lymphocytic leukemia [TendersInfo (India)]
The FDA is also approving new labeling to reflect that Imbruvica s clinical benefit in treating CLL has been verified. We continue to see advances in the availability of therapies to treat chronic lymphocytic leukemia, especially for difficult-to-treat patient populations, said Richard Pazdur, M.D., director of the Office of Hematology and Oncology
7/30/14 - United States : IMBRUVICA (ibrutinib) Receives Regular Approval by U.S. FDA in Chronic Lymphocytic Leukemia (CLL) and CLL patients with del 17p [TendersInfo (India)]
The FDA also approved IMBRUVICA for CLL patients with del 17 p, 1 a genetic mutation that occurs when part of chromosome 17 has been lost. IMBRUVICA was initially approved in February 2014 under Subpart H regulation, the FDA s accelerated approval process, based on data from a Phase 1 b/2 study for patients with CLL who have received at least one p
7/30/14 - United States : MEDTRONIC gets FDA approval to market PRESTIGE LP CERVICAL DISC SYSTEM [TendersInfo (India)]
The U.S. Food and Drug Administration has given approval to Medtronic Inc to market the Prestige LP Cervical Disc System. According to Vincent Traynelis, director of Neurosurgery Spine Services at the Department of Neurosurgery at Rush University Medical Center in Chicago, Our goal was to maintain the same ball-and-trough articulation as in the ori
7/29/14 - AcelRX Selling Off On FDA Reexamination; U.S. FDA Grants Approval for IMBRUVICA
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 28, 2014.{ nfg} Shares of AcelRx Pharmaceuticals are selling off sharply monday morning after a blow from the FDA to Zalviso. AcelRx made the announcement at an unusual time: 9:59 p.m. ET Friday. The FDA is looking for more information on how to u
7/29/14 - Boston Scientific Gets FDA Approval for REBEL Platinum Chromium Coronary Stent System [Manufacturing Close - Up]
Boston Scientific has received FDA approval for the REBEL Platinum Chromium Coronary Stent System, the company's latest generation bare-metal stent for the treatment of coronary artery disease. The REBEL Stent System expands the Boston Scientific family of stents featuring its proprietary platinum chromium alloy and a customized stent architecture.
7/29/14 - Cynosure Announces PicoSure Is FDA-Cleared To Treat Acne Scars
Cynosure, the leader in aesthetic lasers, announced today that PicoSure is the first and only picosecond laser now FDA- cleared to treat acne scars. "We are thrilled to announce that PicoSure, the world's most advanced laser technology for tattoo removal and benign pigmented lesions, has now received FDA- clearance to treat acne scars," says Cynos
7/29/14 - EYLEA (aflibercept) Injection Receives FDA Approval for the Treatment of Diabetic Macular Edema (DME)
Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has approved EYLEA Injection for the treatment of Diabetic Macular Edema. The recommended dosage of EYLEA in patients with DME is 2 milligrams every two months after five initial monthly injections. "Diabetic macular edema is a leading cause of vision l
7/29/14 - Fate Therapeutics Announces FDA Clearance of IND for Clinical Development of PROHEMA in Inherited Metabolic Disorders
Fate Therapeutics, Inc., a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, announced today that the U.S. Food and Drug Administration has cleared its Investigational New Drug Application for the clinical development of PROHEMA in pediatric patients undergoing hematopoie
7/29/14 - Flamel Technologies Announces Second Quarter of Fiscal Year 2014 Results
Flamel Technologies today announced its financial results for the second quarter of fiscal year 2014. Highlights from the quarter include:. Flamel is now the only drug manufacturer offering all three product presentations of phenylephrine hydrochloride injection and will launch before end of the third quarter 2014 The FDA updated its Drug Shortages
7/29/14 - IGI Laboratories Releases 2Q Results [Health & Beauty Close - Up]
IGI Laboratories reported its financial results for the second quarter ended June 30. -IGI filed an additional ANDA, under a joint development agreement with Impax Laboratories, Inc. in June 2014. -IGI received its tentative approval from the FDA for an ANDA for diclofenac sodium 1.5 percent topical solution, and executed an agreement to enable the
7/29/14 - J&J -IMBRUVICA (ibrutinib) Receives Regular Approval by U.S. FDA in Chronic Lymphocytic Leukemia (CLL) and CLL patients with del 17p
Release date- 28072014- HORSHAM, PA,- The U.S. Food and Drug Administration has approved the supplemental New Drug Application for IMBRUVICA capsules for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy. IMBRUVICA is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacycli
Articles(s): 1 - 25 of 51     Next >>     Go To Page:


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