Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers July 23, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - July 23, 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 154     Next >>     Go To Page:

7/14/17 - Amgen Receives FDA Approval For BLINCYTO [All Iraq News Agency (AIN)]
Today, Amgen announced that it had received FDA approval for its drug BLINCYTO. The FDA had approved the Supplemental Biologics License Application sBLA for BLINCYTO, because of results from two positive clinical trials. The drug was approved because of results from a phase 3 study, known as the TOWER study.
7/14/17 - Apexian Pharmaceuticals Announces FDA Agreement For Inclusion of Chemotherapy Induced Peripheral Neuropathy (CIPN) Indication Under Currently Approved IND [Sudan Tribune]
Apexian Pharmaceuticals, a clinical stage biotechnology company developing novel compounds to treat cancer, today announced that it has received FDA agreement that the currently approved IND can be used to examine Chemotherapy Induced Peripheral Neuropathy as an indication in addition to its anti-tumor effects. Mark Kelley, Apexian`s CSO, has recei
7/14/17 - Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval for Azacitidine for Injection Vidaza
By a News Reporter-Staff News Editor at Drug Week Breckenridge Pharmaceutical, Inc. announced that FDA has granted final approval of its ANDA Azacitidine for Injection, 100 mg per vial, Single-Dose Vial, a generic version of Vidaza by Celgene Corporation. Breckenridge submitted the ANDA with its development and manufacturing partner Natco Phar
7/14/17 - Digestive Care, Inc. Announces FDA Approval of a 24,000 USP Lipase Units Capsule of PERTZYE(R) (pancrelipase) Delayed Release Capsules to Treat Exocrine Pancreatic Insufficiency (EPI) Due to Cystic Fibrosis and Other Conditions
Digestive Care, Inc. and its marketing partner to support the U.S. cystic fibrosis community, Chiesi, today announced U.S. Food and Drug Administration approval of PERTZYE in a 24,000 USP lipase units capsule. "Along with our partner, Chiesi, we feel it is important to offer options for enzyme delivery to those with EPI due to CF," said Tibor S
7/14/17 - GSK ships 2017-18 seasonal influenza vaccines for US market
The US Centers for Disease Control and Prevention recommends flu vaccination as the single best measure for flu prevention. The CDC has a routine recommendation for people over the age of 6 months to get a flu vaccination each year as the first and most important step in protecting against this disease. 1,2. In November 2016, GSK received approval
7/14/17 - Janssen Announces U.S. Fda Approval of Tremfya (Guselkumab) for Treatment of Moderate to Severe Plaque Psoriasis
Johnson and Johnson issued the following news release:. Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration has approved TREMFYA for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. "TREMFYA represents a significant milestone in the treatme
7/14/17 - JOHNSON & JOHNSON - JANSSEN ANNOUNCES U.S. FDA APPROVAL OF TREMFYA FOR THE TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS
Release date- 13072017- Horsham, PA- Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration has approved TREMFYA for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 'TREMFYA represents a significant milestone in the treatment of moderate to se
7/14/17 - Lannett Receives Approval For Cyproheptadine Hydrochloride Syrup, 2 mg/5 mL
Lannett Company, Inc. today announced that it received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Cyproheptadine Hydrochloride Syrup 2 mg/5 mL, the therapeutic equivalent to the reference standard drug, Cyproheptadine Hydrochloride Syrup by Lyne Laboratories, Inc. The product was previously mar
7/14/17 - Novel Gene Therapy for Leukemia Clears FDA Panel [Tehran Times (Iran)]
A panel of outside experts convened by the FDA voted 10-0 Wednesday to recommend the approval of Novartis CAR-T therapy, called CTL019, for the treatment of children and young adults with advanced leukemia. The FDA is expected to make a final decision on approval by Oct. 3. The FDA is also reviewing a CAR-T from Kite Pharma for the treatment of adu
7/14/17 - Sihuan Pharm's new drug gets approval for clinical trials [ET Net News (China)]
Sihuan Pharmaceutical said the China Food. and Drug Administration has granted approval of Phase I-III clinical trials of Birociclib,. Sihuan Pharmaceutical Co., Ltd. and Shandong XuanZhu Pharma Co., Ltd..
7/14/17 - USFDA advisory panel unanimously approves first ever leukemia gene treatment [T-break Tech (Middle East)]
The committee recommended that the FDA take the necessary measures to approve the drug, which has been clinically tested. In the case the FDA approves the launch of the drug, called Tisagenlecleucel, it will be the first ever leukemia drug introduced on market. Tisagenlecleucel is an adoptive immunocellular cancer therapy that uses autologous perip
7/13/17 - 'Living drug' that fights cancer by harnessing immune system clears key hurdle
A Food and Drug Administration advisory committee unanimously recommended that the agency approve this "living drug" approach for children and young adults who are fighting a common form of leukemia. If the agency approves, it would mark the first time the FDA has approved anything considered to be a "gene therapy product." Timothy Cripe, an oncolo
7/13/17 - DGAP-Adhoc: Adhoc: MorphoSys Announces That Its Licensee Janssen Has Received US FDA Approval for Tremfya(TM) (Guselkumab) for the Treatment of Moderate to Severe Plaque Psoriasis (english)
Adhoc: MorphoSys Announces That Its Licensee Janssen Has Received US FDA Approval for Tremfya (TM) for the Treatment of Moderate to Severe Plaque Psoriasis ^ DGAP-Ad-hoc: MorphoSys AG/ Key word: Regulatory Approval Adhoc: MorphoSys Announces That Its Licensee Janssen Has Received US FDA Approval for Tremfya (TM) for the Treatment of Moderate to Sev
7/13/17 - DGAP-News: Media Release: MorphoSys Announces That Its Licensee Janssen Has Received US FDA Approval for Tremfya(TM) (Guselkumab) for the Treatment of Moderate to Severe Plaque Psoriasis (english)
Media Release: MorphoSys Announces That Its Licensee Janssen Has Received US FDA Approval for Tremfya (TM) for the Treatment of Moderate to Severe Plaque Psoriasis ^ DGAP-News: MorphoSys AG/ Key word: Regulatory Approval Media Release: MorphoSys Announces That Its Licensee Janssen Has Received US FDA Approval for Tremfya (TM) for the Treatment of M
7/13/17 - FDA approves extended-release triptorelin for central precocious puberty [Sudan Tribune]
The FDA has approved the gonadotropin-releasing hormone agonist triptorelin in a 6- month formulation for the treatment of central precocious puberty, Arbor Pharmaceuticals and Debiopharm International announced in a press release. The approval marks the first new treatment formulation for U.S. children in 6 years and is the first GnRH agonist...
7/13/17 - FDA Grants De Novo Clearance for Z-Medicas QuikClot Control+ [Ghana News Agency]
-Z-Medica, LLC, a leading developer and marketer of hemostatic devices, announces that QuikClot Control+ has been cleared for use by the US Food and Drug Administration under the de novo classification process and is designated as a Class II medical device. Z-Medica has worked tirelessly with the FDA during the de novo process. Joshua P. Hazelton,
7/13/17 - FDA OKs new Johnson & Johnson treatment for psoriasis
U.S. regulators approved a new psoriasis drug from Johnson& Johnson Thursday, giving people with the itchy and painful condition another treatment option. Johnson& Johnson said that in one patient study, about seven in 10 patients getting the drug, Tremfya, had clear or nearly clear skin after 24 weeks of treatment. Johnson& Johnson, based in Ne
7/13/17 - Gene Therapy Now Approved By FDA Panel
The unanimous recommendation from the Oncologic Drugs Advisory Committee means the treatment could be approved by the FDA by the end of September, forging a new path in the immunotherapy frontier. Timothy Cripe, a panel member who is an oncologist with Nationwide Children s Hospital in Columbus, Ohio, called the treatment the most exciting th
7/13/17 - Great Basin Scientific Receives FDA 510(k) Clearance for Stool Bacterial Pathogens Panel
Great Basin Scientific, Inc., a molecular diagnostics company, today announced it has received U. S. Food and Drug Administration 510 clearance for its Stool Bacterial Pathogens Panel. With this FDA clearance, the Company will begin to actively market SBPP to its current customer base of over 230 hospitals and labs, and will commence aggressive o
7/13/17 - Janssen Announces U.S. FDA Approval Of TREMFYA? (Guselkumab) For The Treatment Of Moderate To Severe Plaque Psoriasis
Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration has approved TREMFYA? for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. "TREMFYA? represents a significant milestone in the treatment of moderate to severe plaque psoriasis as evi
7/13/17 - MorphoSys Announces that Its Licensee, Janssen, Has Received US FDA Approval for Tremfya(TM) (Guselkumab) for the Treatment of Moderate to Severe Plaque Psoriasis
First Antibody Generated from MorphoSys's HuCAL Library Technology to Receive Marketing Approval. PLANEGG, MUNICH, GERMANY/ ACCESSWIRE/ July 13, 2017/ MorphoSys AG announced today that its licensee, Janssen Biotech, Inc., has reported that the U.S. Food and Drug Administration has approved Tremfya? for the treatment of patients with moderate to s
7/13/17 - NetworkNewsBreaks Great Basin Scientific, Inc.'s (GBSN) Stool Bacterial Pathogens Panel Obtains FDA 510(k) Clearance
Shares of Great Basin Scientific are up 7% mid-day on news that the company has received U. S. Food and Drug Administration 510 clearance for its Stool Bacterial Pathogens Panel. We also anticipate that with its higher ASP and strong gross margins, SBPP will be a key contributor to Great Basin s profitability goals, Great Basin Scientific co-
7/13/17 - Philips : FDA Oks Wearable Light Therapy Device To Treat Mild Psoriasis
AMSTERDAM- Royal Philips said that it has received 510 clearance from the U.S. Food and Drug Administration to market the Philips BlueControl wearable light therapy device to treat mild psoriasis. In the U.S., BlueControl is a Class II prescription medical device designed for home use. Psoriasis is the most common autoimmune disease in the U.S., af
7/13/17 - Philips receives U.S. FDA 510(k) clearance to market its Philips BlueControl, a wearable light therapy device to treat mild psoriasis at home
Royal Philips, a global leader in health technology, today announced it has received 510 clearance from the U.S. Food and Drug Administration to market the Philips BlueControl wearable light therapy device to treat mild psoriasis. In the U.S., BlueControl is a Class II prescription medical device designed for home use. Following the FDA clearance
7/13/17 - SaeboVR Virtual ADL Rehabilitation System Receives FDA Clearance
The US Food and Drug Administration has granted clearance to the SaeboVR, a virtual ADL (activities of daily living) rehabilitation system designed to provide real-life challenges to help neurological patients rehabilitate their upper extremities.
Articles(s): 1 - 25 of 154     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
Drug Therapy Management Series Part III: Geriatric Disorders
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