Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers November 19, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - November 19, 2017

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 233     Next >>     Go To Page:

11/11/17 - BRIEF: Heron Therapeutics wins approval of cancer drug [The San Diego Union-Tribune]
Nov. 10 San Diego's Heron Therapeutics said Thursday it has received marketing approval for a drug to prevent chemotherapy-associated nausea and vomiting. The injectable drug, Cinivanti, is the second such drug for Heron Therapeutics; the first is Sustol. Cinivanti was approved by the U.S. Food and Drug Administration on the basis of clinical stu
11/11/17 - Dynavax Announces FDA Approval of First and Only Two-Dose Hepatitis B Vaccine [Arab News (Saudi Arabia)]
Dynavax Technologies announced that the U.S. Food and Drug Administration has approved HEPLISAV-B for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. HEPLISAV-B is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adu
11/11/17 - FDA OKs drug to block infection after marrow transplant [Tehran Times (Iran)]
United States regulators have approved the first drug to prevent life-threatening infections in adults after a bone marrow transplant. The Food and Drug Administration approved on Wednesday the sales of Merck and Co.s Prevymix to prevent infections with cytomegalovirus, a common virus. Merck, which is based in Kenilworth, New Jersey, said the drug
11/10/17 - FDA Approves DVAX's Hep B Vaccine, OMER Catches Eyes, It's 4 For SGEN's Adcetris
WASHINGTON- Today's Daily Dose brings you news about the strong Q3 results of Omeros, FDA approvals of hepatitis B vaccine, CINV drug and a lymphoma drug. Shares of Dynavax Technologies Corp. were up more than 15% in extended trading on Thursday, following FDA approval of HEPLISAV-B, the Company's vaccine for prevention of Hepatitis B in adults.
11/10/17 - FDA Approves Genentech's Alecensa as First-Line Treatment for People with Specific Type of Lung Cancer
South San Francisco, CA- Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration approved the supplemental New Drug Application for Alecensa for the treatment of people with anaplastic lymphoma kinase- positive metastatic non-small cell lung cancer as detected by an FDA- approved test.
11/10/17 - FDA clears common blood cell count test that offers faster results for patients and providers
The U.S. Food and Drug Administration today cleared a complete blood cell count test that, based on its categorization, can be run in more health care settings, including physicians' offices, clinics or other types of health care facilities, by a wider range of personnel. This broadened test access will allow for faster availability of results.
11/10/17 - FDA Clears I.C. Medical's Advanced Surgical Smoke Evacuation System
Phoenix, AZ 11/10/2017 The U.S. Food and Drug Administration has granted Phoenix- based I.C. Medical Company 510 clearance to market the Crystal Vision 450 D in the United States on October 30, 2017. The Crystal Vision 450 D is an "intelligent" surgical smoke evacuation device, with sophisticated features and enhanced functionality. It employ
11/10/17 - FDA Clears I.C. Medical's FDA Advanced Surgical Smoke Evacuation System
Phoenix, AZ 11/10/2017 The U.S. Food and Drug Administration has granted Phoenix- based I.C. Medical Company 510 clearance to market the Crystal Vision 450 D in the United States on October 30, 2017. The Crystal Vision 450 D is an "intelligent" surgical smoke evacuation device, with sophisticated features and enhanced functionality. It employ
11/10/17 - Genentech - FDA Approves Zelboraf for Erdheim-Chester Disease with BRAF V600 Mutation
South San Francisco, CA- Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration has approved Zelboraf for Erdheim-Chester disease with BRAF V600 mutation. 'This FDA decision means people living with Erdheim-Chester disease will now, for the first time, have an FDA- approved treatment option,' said Sandra
11/10/17 - LENSAR Receives FDA Clearance for IntelliAxis?-L - LENSAR Laser System's Novel Toric Intraocular Lens Alignment Guidance
LENSAR, Inc., a global leader in next generation femtosecond laser technology for refractive cataract surgery, today announced it received 510 clearance from the U.S. Food and Drug Administration and the European Union CE Mark for IntelliAxis?- L. The company is introducing the new feature with the latest LENSAR Laser System upgrade, Streamlin
11/10/17 - Roche - FDA approves Roche's Alecensa as first-line treatment for people with specific type of lung cancer
Roche today announced that the US Food and Drug Administration approved the supplemental New Drug Application for Alecensa for the treatment of people with anaplastic lymphoma kinase- positive metastatic non-small cell lung cancer as detected by an FDA- approved test.
11/10/17 - Roche - FDA approves Zelboraf for Erdheim-Chester disease with BRAF V600 mutation
Roche announced today that the US Food and Drug Administration has approved Zelboraf for Erdheim-Chester disease with BRAF V600 mutation. 'This FDA decision means people living with Erdheim-Chester disease will now, for the first time, have an FDA- approved treatment option,' said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global
11/10/17 - Sarepta Therapeutics Announces FDA Clearance of IND for the Company's PPMO Exon 51 Candidate SRP-5051
CAMBRIDGE, Mass.- Sarepta Therapeutics, Inc., a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicine to treat rare neuromuscular diseases, announced today that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for the Company's peptide...
11/10/17 - Teligent, Inc. Announces FDA Approval of Betamethasone Dipropionate Ointment USP (Augmented), 0.05%
Teligent, Inc., a New Jersey- based specialty generic pharmaceutical company, today announced it has received approval of the Company s abbreviated new drug application from the U.S. Food and Drug Administration of Betamethasone Dipropionate Ointment USP, 0.05%. Betamethasone Dipropionate Ointment USP, 0.05% is Teligent s seventh FDA app
11/10/17 - UCB's VIMPAT now approved by FDA to treat partial-onset seizures in pediatric epilepsy patients
The prevalence of pediatric epilepsy has been steadily increasing in the U.S.4 Today, it is estimated that about 470,000 children in the U.S. under the age of 18 have epilepsy.2 The U.S. Centers for Disease Control and Prevention estimate that 0.6% of children in the U.S. aged 0-17 years have active epilepsy- equivalent to six students in a school
11/10/17 - United Therapeutics Announces FDA Approval Of Third Generation Nebulizer For The Tyvaso Inhalation System
By a News Reporter-Staff News Editor at Drug Week United Therapeutics Corporation announced approval by the U.S. Food and Drug Administration of a new inhalation device, called the TD-300/A, for use with Tyvaso Inhalation Solution. Tyvaso is the most-prescribed inhalation therapy for PAH in the United States, and since its launch, United Thera
11/9/17 - Cytori Reports Third Quarter 2017 Business and Financial Results
U.S. STAR scleroderma clinical trial data accepted for presentation at Systemic Sclerosis World Congress in February 2018. BARDA executed a $13.4 million contract option to fund the U.S. RELIEF burn clinical trial. Received U.S. FDA IDE approval for RELIEF, a thermal burn pilot trial related to ongoing BARDA contract. Q3 2017 Financial Performance.
11/9/17 - Dynavax Announces FDA Approval of HEPLISAV-B(TM) for Prevention of Hepatitis B in Adults
Dynavax Technologies Corporation today announced that the U.S. Food and Drug Administration has approved HEPLISAV-B for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. HEPLISAV-B is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis
11/9/17 - FDA approves drug developed in Bothell to treat disfiguring blood cancer
BOTHELL Seattle Genetics gained approval Thursday for its drug Adcetris to be used to treat a rare disfiguring blood cancer of the skin. A study found that Adcetris showed far more positive results for test patients than the current drugs in use for cutaneous T-cell lymphoma, said Seattle Genetics CEO Clay B. Siegall. Adcetris has been used to t
11/9/17 - Heron Therapeutics Announces U.S. FDA Approval of CINVANTI? (aprepitant) Injectable Emulsion for the Prevention of Acute and Delayed Chemotherapy-Induced Nausea and Vomiting (CINV)
Heron Therapeutics, Inc., a commercial-stage biotechnology company focused on developing novel, best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and Drug Administration has approved CINVANTI? injectable emulsion, for intravenous infusion. CINVANTI is a substance P/neurokinin-1.
11/9/17 - Merck Gets FDA Approval Of Prevymis For Prevention Of CMV Infection
KENILWORTH- Merck& Co., Inc., known as MSD outside the United States and Canada, said that the U.S. Food and Drug Administration has approved Prevymis or letermovir once-daily tablets for oral use and injection for intravenous infusion. Prevymis is indicated for prophylaxis or prevention of cytomegalovirus or CMV infection and disease in adult...
11/9/17 - Merck Receives FDA Approval of PREVYMIS? (letermovir) for Prevention of Cytomegalovirus (CMV) Infection and Disease in Adult Allogeneic Stem Cell Transplant Patients
Merck& Co., Inc., known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved PREVYMIS? once-daily tablets for oral use and injection for intravenous infusion. PREVYMIS is indicated for prophylaxis of cytomegalovirus infection and disease in adult CMV-seropositive recipients of an all
11/9/17 - NEOS THERAPEUTICS, INC. - 10-Q - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
We received approval from the FDA for Cotempla XR-ODT, our methylphenidate XR-ODT for the treatment of ADHD in patients 6 to 17 years old, on June 19, 2017, initiating an early experience program with limited product availability on September 5, 2017 before launching this product nationwide on October 2, 2017. Also, we received approval from the FD
11/9/17 - Neusoft Medical Systems USA Announces FDA-Clearance of the NeuViz Prime CT Scanner
Neusoft Medical Systems USA announced the FDA market clearance and availability of a new 128- slice CT scanner for US healthcare providers. The latest advance in more than 20 years of continual CT innovation. The NeuViz Prime offers exquisite diagnostic images enhanced by several key features.
11/9/17 - Puma Biotechnology Reports Third Quarter 2017 Financial Results
Puma Biotechnology, Inc., a biopharmaceutical company, announced financial results for the third quarter and nine months ended September 30, 2017. On July 17, 2017, Puma Biotechnology received approval from the U.S. Food and Drug Administration for NERLYNX for the treatment of early stage HER2-positive breast cancer following adjuvant...
Articles(s): 1 - 25 of 233     Next >>     Go To Page:


© 2017 Thomson Reuters. All rights reserved.

Pharmacy News Index
  Drug Delivery Systems
  Drugstores
  FDA Final Approvals
  Front Page Healthcare News
  Generic Drugs
  Hospital Industry
  Internet Pharmacy
  IT in Healthcare
  Medicare & Medicaid
  Over-the-Counter Drugs
  Pharm Industry Trends and Policy
  Pharmaceutical Development
  Pharmaceutical Industry

FEATURED CE LESSON

Legal & Practical Issues in Compounding Pharmacy
This lesson is supported by:
RxSchool
Men's Health in Older Adults: Benign Prostatic Hyperplasia and Erectile Dysfunction
This lesson is supported by:
RxSchool
Pharmacy Spanish
This lesson is supported by:
RxSchool

Special Announcement

Free Membership
Enjoy Drug Search, industry newsletters and more...


Websites » RxCareerCenter.comRxSchool.comClubStaffing.comNursingJobSource.comRN.com
Copyright © 2017 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement
888-682-4415