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 The leading web portal for pharmacy resources, news, education and careers April 22, 2018
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - April 22, 2018

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 86     Next >>     Go To Page:

4/21/18 - AZ`s Tagrisso gets FDA nod in first-line EGFR-mutated lung cancer [Tehran Times (Iran)]
AstraZeneca has announced that its epidermal growth factor receptor tyrosine kinase inhibitor Tagrisso has received approval from the FDA for the first-line treatment of metastatic non-small cell lung cancer in patients whose tumours have EGFR mutations, specifically exon 19 deletions or exon 21 L858R mutations, as detected by an FDA- approved test
4/21/18 - AZs Tagrisso approved for untreated lung cancer in US [Tehran Times (Iran)]
AstraZenecas Tagrisso looks set to gain further traction after the FDA approved it in first-line treatment for lung cancer patients with a certain mutation. Dr Suresh Ramalingam, principal investigator of the FLAURA trial, from Winship Cancer Institute of Emory University, Atlanta, said: The approval of osimertinib in the first-line setting represe
4/21/18 - FDA approves first contact lens that gets darker in sunlight [Tehran Times (Iran)]
The U.S. Food and Drug Administration has signed off on the first ever transition contact lenses, which will get darker when the wearer is out in sunlight. The Acuvue Oasys transition contact lenses are from Johnson& Johnson Vision Care, Inc.. Johnson& Johnson says the new lenses will hit the market during the "first half of 2019.".
4/21/18 - FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia [Sudan Tribune]
The U.S Food and Drug Administration has approved Crysvita, the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia, a rare, inherited form of rickets. XLH differs from other forms of rickets in that vitamin D therapy is not effective, stated Dr Julie Beitz, director of the Office of Drug Evaluation
4/21/18 - FDA Approves Fostamatinib for ITP After Insufficient Response to Previous Treatment [T-break Tech (Middle East)]
Fostamatinib disodium hexahydrate, a kinase inhibitor, was granted FDA approval for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had insufficient response to a previous treatment. Recommended dose is 100 mg orally twice daily. If a platelet count of at least 50109/ L is not achieved in 1 month af
4/21/18 - FDA Approves Osimertinib for Treatment of Non-Small Cell Lung Cancer [Tehran Times (Iran)]
Officials with the FDA have approved osimertinib for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor mutations, according to a press release. Osimertinib is already approved in the United States for the second-line treatment of patients with metastatic EGFRm NSCLC,..
4/21/18 - FDA clears first therapy for inherited rickets [Sudan Tribune]
US regulators have approved the first drug to treat adults and children with x-linked hypophosphatemia, a rare, inherited form of rickets. Ultragenyx Pharmaceutical and Kyowa Hakko Kirins Crysvita is an antibody that blocks fibroblast growth factor 23, a hormone that causes phosphate urinary excretion and suppresses active vitamin D production by t
4/21/18 - Helsinn Group announces the FDA approval of the IV formulation of AKYNZEO (fosnetupitant/ palonosetron) in the United States
-Helsinn Group announces the FDA approval of the IV formulation of AKYNZEO in the United States. Lugano, Switzerland April 20, 2018- Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, today announces that the U.S. Food and Drug Administration has approved the intravenous formulation of AKYNZEO as an alternative
4/21/18 - Rigel and Ultragenyx claim approvals for rare drugs [All Iraq News Agency (AIN)]
The FDA gave the go-ahead to a pair of rare disease therapies this week, both marking the first-ever approvals for developers Rigel Pharmaceuticals and Ultragenyx. Rigel got a green light from the FDA for chronic immune thrombocytopenia therapy Tavalisse, although there was a sense of dj vu as it prematurely published a press release on its website
4/21/18 - U.S. Regulators Consider Ideas for Boosting Medical Device Safety [T-break Tech (Middle East)]
Among other measures, the FDA will consider requiring more training for doctors who implant certain high-risk devices. Other proposals may require additional money from Congress. The FDA has repeatedly been forced to issue safety alerts about unexpected problems with devices that only appeared years after they were approved for use in patients.
4/21/18 - Urotronic Urethral Stricture Device Approved for Pivotal Phase 3 Trial [Syrian Arab News Agency]
Urotronic Inc. has gotten the green light for a pivotal phase 3 clinical trial. The US Food and Drug Administration has granted approval to the Minneapolis- based early-stage medical device company to begin its second US study of the Optilume Drug Coated Balloon catheter for the treatment of men with urethral strictures. It follows the first FDA- a
4/21/18 - US Food and Drug Administration Now Approves Distribution of Suboxones Generic Version in the USA [Saudi Gazette, The]
-Heroin Detox Clinics completes guide to Suboxone and questions related to the drug in new post. The US Food and Drug Administration recently approved the manufacturing and distribution of the generic version of Suboxone in the American market. One of the most prevalent issues in many developed nations including the United States is opioid...
4/20/18 - Advanced Biomedical Technologies Inc. Announces Chinese CFDA Approval of Polymer Fixation Screws
Advanced Biomedical Technologies, a developer and manufacturer of orthopaedic internal fixation devices, announced today that it has received approval from the China Food and Drug Administration for its polymer orthopaedic internal fixation screws. As quoted in the press release:. Company CEO Ms Hui Wang said, Today is a momentous day for our co
4/20/18 - Advanced Biomedical Technologies Inc. Announces Chinese CFDA Approval of Polymer Fixation Screws [Syrian Arab News Agency]
-Advanced Biomedical Technologies Inc., a developer and manufacturer of orthopaedic internal fixation devices, announced today that it has received approval from the China Food and Drug Administration for its polymer orthopaedic internal fixation screws. Company CEO Ms Hui Wang said, Today is a momentous day for our company and biomaterial technolo
4/20/18 - FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia
The FDA has approved Crysvita, the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia, a rare, inherited form of rickets... The post FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia appeared first on European Pharmaceutical Review.
4/20/18 - FDA releases new action plan looking to improve device cybersecurity, streamline approvals [Yemen News Agency]
The plan focuses on five key areas, including improving medical device cybersecurity, integrating premarket and postmarket activities to monitor the total product lifecycle of products, establishing a medical device patient safety net in the US, exploring regulatory options to streamline and modernize implementation of postmarket mitigations and...
4/20/18 - Helsinn Group announces the FDA approval of the IV formulation of AKYNZEO (fosnetupitant/ palonosetron) in the United States
Helsinn Healthcare SA/ Helsinn Group announces the FDA approval of the IV formulation of AKYNZEO in the United States. Helsinn Group announces the FDA approval of the IV formulation of AKYNZEO in the United States Lugano, Switzerland April 20, 2018- Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, today ann
4/20/18 - QIAGEN Announces FDA Approval of PartoSureTM
GERMANTOWN, Md.& HILDEN, Germany QIAGEN N.V. today announced the U.S. regulatory approval of PartoSure TM, which is a novel test for assessing the risk of spontaneous preterm birth in patients with symptoms of preterm labor. The pre-market approval of PartoSure by the U.S. Food and Drug Administration follows successful uptake of the rapid, acc
4/20/18 - Shire plc - FDA approves VONVENDI for perioperative management of bleeding in adult patients with von Willebrand disease
Cambridge- Shire plc, the global biotechnology leader in rare disease, today announced the U.S. Food and Drug Administration has approved VONVENDI, a recombinant von Willebrand factor treatment for perioperative management of bleeding in adults with von Willebrand disease. 1 VONVENDI is also indicated for on-demand treatment and control of bleeding
4/20/18 - SpeeDx receives FDA clearance for Mycoplasma genitalium product
-SpeeDxs ResistancePlus MG Positive Control kit has now been listed with the US Food and Drug Administration for sale in the United States through the companys recently incorporated US entity, SpeeDx Inc. The announcement coincides with the FDA registration of the Australian parent company SpeeDx Pty Ltd as a Medical Device Manufacturing Establishm
4/20/18 - US Food and Drug Administration Now Approves Distribution of Suboxone's Generic Version in the USA
Heroin Detox Clinics completes guide to Suboxone and questions related to the drug in new post. The US Food and Drug Administration recently approved the manufacturing and distribution of the generic version of Suboxone in the American market. One of the most prevalent issues in many developed nations including the United States is opioid depende
4/20/18 - Varian Calypso Anchored Beacon Transponder for Lung Receives FDA 510k Clearance
Varian today announced it has received FDA 510 clearance for its Calypso Anchored Beacon transponder. Used with a Varian TrueBeam , Edge and Clinac C-series medical linear accelerators, the Calypso system and Anchored Beacon transponder detects even slight movements of a tumor and helps clinicians deliver lung stereotactic body radi
4/20/18 - Varian Medical Gets FDA Clearance For Calypso Anchored Beacon Transponder
WASHINGTON- Varian Medical Systems, Inc. said it has received FDA 510 clearance for its Calypso Anchored Beacon transponder. Used with a Varian TrueBeam, Edge and Clinac C-series medical linear accelerators, the Calypso system and Anchored Beacon transponder detects even slight movements of a tumor and helps clinicians deliver lung stereotactic bod
4/19/18 - Advanced Biomedical Technologies Inc. Announces Chinese CFDA Approval of Polymer Fixation Screws
Advanced Biomedical Technologies Inc., a developer and manufacturer of orthopaedic internal fixation devices, announced today that it has received approval from the China Food and Drug Administration for its polymer orthopaedic internal fixation screws. Company CEO Ms Hui Wang said, Today is a momentous day for our company and biomaterial tech
4/19/18 - AstraZeneca Says FDA Approves Tagrisso For 1st-line Use In NSCLC
LONDON- AstraZeneca Plc. announced that the US Food and Drug Administration has approved Tagrisso or osimertinib for the 1st- line treatment of patients with metastatic non-small cell lung cancer or NSCLC whose tumours have epidermal growth factor receptor or EGFR mutations,, as detected by an FDA- approved test. The approval is based on results fr
Articles(s): 1 - 25 of 86     Next >>     Go To Page:


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