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 The leading web portal for pharmacy resources, news, education and careers March 31, 2015
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - March 31, 2015

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 46     Next >>     Go To Page:

3/30/15 - AstraZeneca Says FDA Approves New Administration Option For BRILINTA
LONDON- AstraZeneca PLC announced the US FDA has approved a new administration option for acute coronary syndrome patients who are unable to swallow BRILINTA 90 mg tablets whole. The company said, unlike other P2Y12 inhibitors, BRILINTA has FDA approval to be crushed and administered in water by swallowing or via nasogastric tube. Shares in AstraZe
3/30/15 - AstraZeneca: FDA Approves New Administration Option For BRILINTA
LONDON- AstraZeneca announced the US FDA has approved a new administration option for acute coronary syndrome patients who are unable to swallow BRILINTA 90 mg tablets whole. The company said, unlike other P2Y12 inhibitors, BRILINTA has FDA approval to be crushed and administered in water by swallowing or via nasogastric tube. BRILINTA is an oral..
3/30/15 - Boston Scientific announces FDA and CE Mark Approval Of The EMBLEM? S-ICD System
By a News Reporter-Staff News Editor at Biotech Business Week Boston Scientific Corporation has received FDA and CE Mark approval of the EMBLEM? Subcutaneous Implantable Defibrillator System. A controlled and limited market release has begun in a small number of European centers with a broad European launch scheduled for May 2015 and subsequent
3/30/15 - Boston Scientific Receives FDA Approval for WATCHMAN? Left Atrial Appendage Closure Device
By a News Reporter-Staff News Editor at Biotech Business Week Boston Scientific Corporation has received U.S. Food and Drug Administration approval for the WATCHMAN Left Atrial Appendage Closure Device. "The WATCHMAN Device is an important step forward in stroke management for patients with AF," said Vivek Reddy, M.D., Director of the Cardiac Ar
3/30/15 - BRILINTA Receives US FDA Approval for New Administration Option
AstraZeneca today announced that the US Food and Drug Administration has approved a new administration option for acute coronary syndrome patients who are unable to swallow BRILINTA 90 mg tablets whole. Unlike other P2Y12 inhibitors, BRILINTA has FDA approval to be crushed and administered in water by swallowing or via nasogastric tube.
3/30/15 - CASI Pharmaceuticals Receives Approval From CFDA For Phase 2 Clinical Trial In China With ENMD-2076 For Ovarian Clear Cell Carcinoma
CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced today that the China Food and Drug Administration has approved the Company's application.
3/30/15 - CHOLBAM cholic acid Now Approved In The U.S. For Patients With Bile Acid Synthesis Disorders
By a News Reporter-Staff News Editor at Pharma Business Week Asklepion Pharmaceuticals, LLC. announced that the U.S. Food and Drug Administration approved CHOLBAM? as a once-daily treatment for cholic acid deficiency in bile acid synthesis disorders due to single enzyme defects. CHOLBAM is the first medication approved by the FDA to turn off a.
3/30/15 - Genzyme's Cerdelga (eliglustat) Capsules Approved in Japan
Genzyme, a Sanofi company, announced today that the Ministry of Health, Labor and Welfare has granted marketing approval for Cerdelga , the only oral therapy for the treatment of adults with Gaucher disease type 1 in Japan. Cerdelga was approved by the U.S. Food and Drug Administration in August 2014, the European Commission in January 2015, and
3/30/15 - GNW-News: Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload (english)
Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload. Novartis International AG/ Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload. Basel, March 30, 2015- Novartis announced today that the US Food and Drug...
3/30/15 - Just Approved By FDA, New Ground Breaking Procedure for Heart Rhythm Patients
By a News Reporter-Staff News Editor at Pharma Business Week The Arizona Heart Rhythm Center will be the only medical facility in Arizona with access to a new device developed to lower the risk of stroke in patients with an irregular heartbeat who require blood thinning medications. The device, called the Watchman Left Atrial Appendage Closure
3/30/15 - Kalorama: 23andMe FDA Approval Clears Way for More Sequencing-Based Tests
By a News Reporter-Staff News Editor at Biotech Business Week- Kalorama information suggests that the FDA approval of a rare gene test from Mountain View, Calif.- based personal genetics company 23 andMe will open the way for more genetic tests sold to consumers or prescribed by doctors that use next-generation sequencing technology. A Feb. 19 ap
3/30/15 - Novartis announces FDA approval for Jadenu? to simplify treatment administration for patients with chronic iron overload
Novartis announced today that the US Food and Drug Administration has approved Jadenu? tablets, a new oral formulation of Exjade tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes i
3/30/15 - Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload
Novartis International AG/ Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload. Processed and transmitted by NASDAQ OMX Corporate Solutions. *Jadenu, a new formulation of Exjade, is the only once-daily oral tablet for iron chelation* Jadenu, taken with or without food, simplifies
3/30/15 - Semler Announces FDA Clearance for Next Generation PAD Testing System
By a News Reporter-Staff News Editor at Pharma Business Week Semler Scientific, Inc., an emerging medical risk assessment company that develops, manufactures and markets patented products that assist healthcare providers in monitoring patients and evaluating chronic diseases, announced receipt of 510 marketing clearance from the U.S. Food and Dru
3/30/15 - Toshiba's Infinix 4DCT Receives FDA Clearance with Aquilion PRIME CT Configuration
By a News Reporter-Staff News Editor at Cardiovascular Week ACC Booth #1916- Expanding the industry's first seamless integration between interventional labs and CT technology, Toshiba America Medical Systems, Inc.' s all-new Infinix? 4 DCT has received FDA clearance with the Aquilion? PRIME CT system configuration. Toshiba's Infinix 4 DCT is
3/30/15 - U.S. Food and Drug Administration Approves Cholbam for the Treatment of Rare Bile Acid Synthesis Disorders and Grants Rare Pediatric Disease Priority...
By a News Reporter-Staff News Editor at Clinical Trials Week Retrophin, Inc. announced that the U.S. Food and Drug Administration has approved Cholbam capsules, the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders.
3/30/15 - Vertex Receives U.S. Food and Drug Administration Approval of KALYDECO ivacaftor for Children with Cystic Fibrosis Ages 2 to 5 who have Specific...
By a News Reporter-Staff News Editor at Pharma Business Week Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration approved KALYDECO for use in children ages 2 to 5 with cystic fibrosis who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator gene. The approval is based on previ
3/30/15 - VuCOMP Announces FDA Approval of M-Vu Computer-Aided Detection CAD for Mammography Version 3.2
By a News Reporter-Staff News Editor at Pharma Business Week VuCOMP, Inc., leading developer of advanced computer vision systems for the detection of breast cancer, announced that it has received U.S. Food and Drug Administration approval for M-Vu CAD for mammography version 3.2. In addition to M-Vu CAD, VuCOMP has developed and commercialized M-
3/28/15 - Boston Scientific Gets FDA and CE Mark Approval of the EMBLEM S-ICD System [Manufacturing Close - Up]
Boston Scientific Corp. has received FDA and CE Mark approval of the EMBLEM Subcutaneous Implantable Defibrillator System. A controlled and limited market release has begun in a small number of European centers with a broad European launch scheduled for May 2015 and subsequent U.S. launch planned for the third quarter of 2015.. "We are excited to
3/28/15 - FDA Approves Biotronik ProMRI Eluna Pacemaker System [Professional Services Close - Up]
Biotronik reported that the Food and Drug Administration has approved its ProMRI Eluna pacemaker system. In a release, Biotronik noted that its ProMRI technology allows patients to undergo full-body magnetic resonance imaging scans with both single-chamber and dual-chamber Eluna pacemakers when implanted with Setrox pacing leads.
3/27/15 - Boston Scientific Reports First U.S. Commercial Procedures with WATCHMAN Left Atrial Appendage Closure Device [Health & Beauty Close - Up]
Boston Scientific reported that three patients in the United States received the first implants of its WATCHMAN Left Atrial Appendage Closure Device. The WATCHMAN Device received U.S. Food and Drug Administration approval on Friday, March 13. "Boston Scientific is proud to work with physicians in making a meaningful impact on patient lives by brin
3/27/15 - Dr. Robert Leonard Applauds FDA Clearance of Capillus272Pro? Hair Loss Laser Cap
Earlier this year, the Capillus272Pro? received FDA clearance for the promotion of hair regrowth in adult men and women with androgenic alopecia having Ludwig Savin classifications I-II or Norwood Hamilton classifications of IIa-V and Fitzpatrick Classification of Skin phototypes I-IV. "I am extremely excited that the U.S. Food and Drug Administ
3/27/15 - United States : FDA approves treatment for inhalation anthrax [TendersInfo (India)]
The U.S. Food and Drug Administration yesterday approved Anthrasil, Anthrax Immune Globulin Intravenous, to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs. Because Anthrasil was not approved, its use prior to today s approval would have required an emergency use authorization from the FDA.
3/26/15 - Beaumont Hospital, Royal Oak among first to offer alternative to blood-thinning medications for atrial fibrillation
Cardiologists at Beaumont Hospital, Royal Oak have performed the Midwest's first commercial implant of a device recently approved by the Food and Drug Administration for patients with non-valvular atrial fibrillation. By closing the left atrial appendage, the device has been demonstrated to significantly reduce the risk of death and stroke, compa
3/26/15 - EBS, REGN Get FDA Nod, OVAS To Deliver, Recro Recuperates, Watch Out For ZSAN
The company also intends to commence its phase 3 program in hyperhidrosis for DRM04 in the second half of the year, subject to an end-of-phase 2 meeting with the FDA. Emergent BioSolutions Inc.' s Anthrasil has received FDA approval for treatment of inhalational anthrax in combination with appropriate antibacterial drugs. Anthrasil qualifies for se
Articles(s): 1 - 25 of 46     Next >>     Go To Page:


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