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 The leading web portal for pharmacy resources, news, education and careers July 17, 2018
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - July 17, 2018

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 62     Next >>     Go To Page:

7/17/18 - U.S. Approves New Drug To Treat Smallpox To Counter Risk Of Bio-Terrorism [Daily Independent (Nigeria)]
The U.S. Food and Drug Administration has approved the new drug tecovirimat to treat smallpox, the first drug against the deadly disease since a huge vaccination campaign over three decades ago. To address the risk of bio-terrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that
7/16/18 - ABBOTT RECEIVES FDA APPROVAL FOR NEXT-GENERATION MITRACLIP DEVICE TO TREAT PEOPLE WITH LEAKY HEART VALVES
ABBOTT PARK- Abbott today announced it received approval from the U.S. Food and Drug Administration for a next-generation version of its leading MitraClip heart valve repair device used to repair a leaky mitral valve without open-heart surgery. Abbott received CE Mark for the next-generation device earlier this year, allowing for sale of the device
7/16/18 - Acron Medical Announces FDA 510(k) Clearance of its Signature PEEK TLIF Interbody System, the ACRON Interbody.
Acron Medical, LLC, part of the spineMED Group, is a spine technology organization, dedicated to developing and commercializing globally innovative spinal implants. The company is proud to announce that it has received 510 clearance from the FDA for its signature new technology, the ACRON TLIF Interbody system. Andreas Bernegger, Acron Medical's Co
7/16/18 - Aucta Receives its First Product Approval and Launches Vigabatrin for Oral Solution Under the Brand Name Vigadrone?
Aucta Pharmaceuticals, Inc. announced today that it has begun shipping Vigabatrin for Oral Solution, USP, 500 mg, following final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application. Aucta's commercial partner Upsher-Smith Laboratories, LLC will launch vigabatrin for oral solution under the brand name Viga
7/16/18 - Braeburn Announces PDUFA Date for CAM2038 for the Treatment of Opioid Use Disorder
PLYMOUTH MEETING, Pa., July 16, 2018/ PRNewswire/ Braeburn announces that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act goal date of December 26, 2018 for its New Drug Application for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly subcutaneous depot injection for the treatment of a
7/16/18 - Calcitriol New Contract Manufacturing Submission Receives FDA Approval and Allows Rockwell Medical Commercialization of Calcitriol
Rockwell Medical, Inc. today provided an update regarding Calcitriol, the Company's FDA approved active vitamin D injection for the management of hypocalcemia in patients undergoing chronic hemodialysis. On July 11, 2018, Rockwell Medical received FDA approval of its Prior Approval Supplement for manufacturing Calcitriol. As previously announced,
7/16/18 - Embolx Announces FDA Clearance of Next Generation Sniper Balloon Occlusion Microcatheter to Deliver Pressure-Directed Therapy for Tumors, Enlarged...
By a News Reporter-Staff News Editor at Pharma Business Week Embolx, Inc., a medical device company developing microcatheters for arterial embolization procedures, announced that the company has received 510 clearance from the United States Food and Drug Administration for its next generation family of Sniper Balloon Occlusion Microcatheters,
7/16/18 - FDA approves first drug to treat smallpox
The U.S. Food and Drug Administration has approved the first drug to treat smallpox. The federal agency gave the go ahead Friday to tecovirimat, with the brand name TPOXX, by SIGA Technologies Inc., after trials in animals and humans. Scott Gottlieb, FDA commissioner, said in a statement.
7/16/18 - FDA Approves First Drug to Treat Smallpox [All Iraq News Agency (AIN)]
The US Food and Drug Administration announced Friday its approval of the first drug to treat smallpox. Smallpox is spread by direct contact, and symptoms begin 10 to 14 days after a person is infected, according to the FDA. This is why the FDA gave priority review to TPOXX, a small-molecule antiviral treatment made by SIGA Technologies Inc..
7/16/18 - FDA approves the first drug with an indication for treatment of smallpox
The US Food and Drug Administration has approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox... The post FDA approves the first drug with an indication for treatment of smallpox appeared first on European Pharmaceutical Review.
7/16/18 - FDA Approves XEOMIN incobotulinumtoxinA for Adult Patients with Sialorrhea
By a News Reporter-Staff News Editor at Pharma Business Week Merz North America announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application for XEOMIN for the treatment of chronic sialorrhea, or excessive drooling, in adult patients. XEOMIN is the first and only neurotoxin with this approved
7/16/18 - Health Canada Cleared EmeTerm Anti-Nausea Wristband and HeadaTerm Anti-Migraine Head Patch
By a News Reporter-Staff News Editor at Pain& Central Nervous System Week Shortly after WAT Medical's leading product to treat nausea-induced vomiting, EmeTerm, received its FDA clearance earlier in April, it has now also received official clearance from Health Canada. Health Canada ensures all of its certified medical products are of the highest
7/16/18 - Lupin receives FDA approval for generic Nitrofurantoin Capsules USP, 50 mg and 100 mg
Mumbai- Pharma major Lupin announced that it has received final approval for its Nitrofurantoin Capsules USP, 50 mg and 100 mg from the United States Food and Drug Administration to market a generic version of Alvogen Malta Operations Ltd.' s Macrodantin Capsules, 50 mg and 100 mg. Lupin's Nitrofurantoin Capsules USP, 50 mg and 100 mg is the generi
7/16/18 - Medtronic Receives FDA Approval for Less-Invasive Heart Pump Implant Procedure
DUBLIN- Medtronic plc has received United States Food and Drug Administration approval for a less-invasive implant approach of its HVAD System, a left ventricular assist device for patients with advanced heart failure. The HVAD System is the smallest commercially available LVAD, and the only LVAD approved in the U.S. for implant via thoracotomy, a
7/16/18 - Oyster Point Pharma Announces FDA Clearance of Investigational New Drug Application for the Treatment of Dry Eye Disease
By a News Reporter-Staff News Editor at Pharma Business Week Oyster Point Pharma, Inc., a clinical-stage pharmaceutical company, announced that the U.S. Food and Drug Administration has cleared the company's Investigational New Drug application to proceed with clinical development of OC-01, an investigational compound intended to stimulate natura
7/16/18 - Quidel Receives FDA Clearance for Solana Bordetella Complete Molecular Diagnostic Assay for the Detection of Pertussis (Whooping Cough), Parapertussis Infections
Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510 clearance from the United States Food and Drug Administration to market its Solana Bordetella Complete Assay, a molecular diagnostic assay to be used with the Solana molecula
7/16/18 - Shape Memory Medical Receives FDA Clearance for the IMPEDE Embolization Plug
By a News Reporter-Staff News Editor at Biotech Business Week Shape Memory Medical Inc. announced it has received 510 clearance from the US Food and Drug Administration for the IMPEDE Embolization Plug. Jafar Golzarian, Radiologist with University of Minnesota Health stated, "It is exciting to see the approval of new developments in embolization.
7/16/18 - Siga Continues Rally After FDA Approves Smallpox Drug
The U.S. Food and Drug Administration approved the first treatment of smallpox on Friday. Siga Technologies announced the FDA' s approval of TPOXX, or tecovirimat. The pathogen could be used maliciously, according to the FDA.
7/16/18 - Stryker receives US FDA Pre-market approval for the Surpass Streamline? Flow Diverter to treat large and giant unruptured aneurysms
KALAMAZOO, Michigan, USA, July 16, 2018/ PRNewswire/ Stryker Corporation announced today that the U.S. Food and Drug Administration has granted pre-market approval for the Surpass Streamline Flow Diverter to treat unruptured large and giant wide neck intracranial aneurysms. Philip Meyers, Professor of Radiology and Neurological Surgery at New Yor
7/16/18 - Study Findings from Food and Drug Administration Broaden Understanding of Opioids (New Opioid Analgesic Approvals and Outpatient Utilization of...
According to news reporting out of Silver Spring, Maryland, by NewsRx editors, research stated, "The opioid epidemic, driven in part by increased prescribing, is a public health emergency. Our news journalists obtained a quote from the research from Food and Drug Administration, "Prescribing patterns based on dispensed prescription claims from the
7/16/18 - SuperSonic Imagine Granted FDA Clearance and CE Marking for Disruptive New Aixplorer MACH 30 Ultrasound System
SuperSonic Imagine, a company specialised in ultrasound medical imaging, today announces it has received 510 clearance from the US Food and Drug Administration and authorization to use the CE marking from the LNE/GMed for its new cutting-edge smart ultrasound system, the Aixplorer MACH 30.. The FDA 510 and CE Mark are critical milestones in
7/16/18 - SuperSonic ImagineGranted FDA Clearance and CE Marking for Disruptive New Aixplorer MACH 30 Ultrasound System
SuperSonic Imagine, a company specialised in ultrasound medical imaging, today announces it has received 510 clearance from the US Food and Drug Administration and authorization to use the CE marking from the LNE/GMed for its new cutting-edge smart ultrasound system, the Aixplorer MACH 30.. The FDA 510 and CE Mark are critical milestones in t
7/16/18 - U.S. Approves New Drug To Treat Smallpox To Counter Risk Of Bio-Terrorism [Daily Independent (Nigeria)]
The U.S. Food and Drug Administration has approved the new drug tecovirimat to treat smallpox, the first drug against the deadly disease since a huge vaccination campaign over three decades ago. To address the risk of bio-terrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that
7/14/18 - FDA Approves the First Drug With an Indication for Treatment of Smallpox
The U.S. Food and Drug Administration today approved TPOXX, the first drug with an indication for treatment of smallpox. This new treatment affords us an additional option should smallpox ever be used as a bioweapon, "said FDA Commissioner Scott Gottlieb, M.D. Today's action reflects the FDA' s commitment to ensuring that the U.S. is prepared for a
7/14/18 - First drug to treat smallpox gets FDA approval, in case of bioterrorism
So the U.S. Food and Drug Administration on Friday approved the first drug that could treat it. To address the risk of bioterrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be employed as weapons. Today s approval provides an important milestone in these efforts, FDA
Articles(s): 1 - 25 of 62     Next >>     Go To Page:


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