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 The leading web portal for pharmacy resources, news, education and careers November 14, 2018
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - November 14, 2018

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 42     Next >>     Go To Page:

11/14/18 - Canon Medical Receives FDA Clearance for Premium MR System: Vantage Orian 1.5T
Canon Medical Systems USA, Inc. has received 510 clearance on its new premium MRI system, Vantage Orian? 1.5 T. The Vantage Orian represents a new standard in the premium wide bore 1.5 T market with new technology designed to boost productivity, enhance patient comfort and deliver diagnostic clinical confidence. We are committed to offering ou
11/14/18 - FDA Approves Empliciti Combination for Relapsed or Refractory Multiple Myeloma [Syrian Arab News Agency]
The U.S. Food and Drug Administration has approved Bristol-Myers Squibbs Empliciti, in combination with Pomalyst and low-dose dexamethasone, as a treatment for patients with relapsed or treatment-resistant multiple myeloma. Empliciti plus pomalidomide and dexamethasone has been proven to extend the time that certain patients live without disease...
11/14/18 - Pfizer`s Groton facility plays key role in recent FDA approvals [T-break Tech (Middle East)]
Pfizer Inc. is on a roll, gaining U.S. Food and Drug Administration approval of three anti-cancer drugs in the last two months. Lorbrena, the most recently approved of the three, got the nod in early November, Pfizer has announced, following clinical trials that demonstrated its effectiveness in treating non-small cell lung cancer among patients wi
11/14/18 - Regulatory Approval
Stallergenes Greer Announces U.S. FDA Approval of Pediatric Indication Extension for Oralair Sublingual Immunotherapy Tablet for the Treatment of Grass Pollen Allergy. Stallergenes Greer, a biopharmaceutical company specializing in treatments for respiratory allergies, today announced that it has received approval from the U.S. Food and Drug...
11/14/18 - Stallergenes Greer Announces U.S. FDA Approval of Pediatric Indication Extension for Oralair Sublingual Immunotherapy Tablet for the Treatment of Grass Pollen Allergy
Stallergenes Greer, a biopharmaceutical company specializing in treatments for respiratory allergies, today announced that it has received approval from the U.S. Food and Drug Administration for the extension of the indication for Oralair , an allergy immunotherapy sublingual tablet, to treat patients ages five to nine with grass pollen-induced..
11/13/18 - Bio2 Technologies, Inc. Receives FDA IDE Approval to Begin Clinical Study of Resorbable Cervical Interbody Device for Spinal Fusion
Bio2 Technologies, Inc., a privately held orthopedics company, announced today that it received U.S. Food and Drug Administration approval to begin enrollment in an IDE clinical study to evaluate Vitrium as a cervical interbody fusion device. "Our positive ovine study results presented at last year's North American Spine Society, showing Vitrium
11/13/18 - Cipla receives final approval for generic version of Roche's Valcyte
Mumbai- Cipla Limited today announced that it has received final approval for its Abbreviated New Drug Application for Valganciclovir Tablets 450 mg from the United States Food and Drug Administration. Cipla's Valganciclovir Tablets 450 mg is AB-rated generic therapeutic equivalent version of Roche's Valcyte. Established in 1935, Cipla is a global.
11/13/18 - Cosmetic Implant Market Reach USD 11.2 Bn | By Innovative Treatments, Key Methodologies, Challenges and Forecast Up To 2022
For instance, Sientra has recently received approval from FDA to launch their breast implant line Opus. On the other hand, New York's Hospital for Special Surgery and pSivida have collaborated in their effort to create a knee implant to improve knee osteoarthritis pain. Some of the key players in this market are LABORATOIRES ARION, CEREPLAS, 3 M, I
11/13/18 - Cycle Pharmaceuticals Receives Approval for Updated Infant Administration for NITYR Tablets for HT-1 in U.S.
BOSTON- Cycle Pharmaceuticals is pleased to announce that the U.S. Food and Drug Administration has approved a new version of the NITYR Prescribing Information including an improvement to the administration procedure for infants using an oral syringe. NITYR is indicated for the treatment of patients with hereditary tyrosinemia type 1 in combination
11/13/18 - Esco Medical secures CFDA approval on the MIRI(R) TL and MIRI(R) Embryo Incubators
Esco Medical, the IVF medical technology business unit of the Esco Group, today announced that it has received the China Food and Drug Administration approval on the MIRI Time-Lapse and MIRI Benchtop Multi-room embryo incubators. The MIRI TL is a time-lapse incubator with a built-in camera that captures continuous images during the embry
11/13/18 - FDA Grants DeNovo Clearance to Atlantic Therapeutics for INNOVO Therapy Device to Treat Stress Urinary Incontinence
GALWAY, Ireland Atlantic Therapeutics, a global manufacturer of innovative, garment-based pelvic floor muscle strengthening and nerve stimulation products, announced today that the U.S. Food and Drug Administration has granted a DeNovo clearance for its INNOVO therapy device, an externally worn electrical muscle stimulator for the treatment
11/13/18 - Lumendi Receives FDA 510(k) Clearance for Innovative DiLumen? EIP Device Modification to Improve Tissue Retraction During Therapeutic Endoscopy
Connecticut- based medical device innovator Lumendi, LLC has received U.S. Food and Drug Administration clearance for its DiLumen? EIP technology with suture loops placed in the skirt along the trailing edge of the fore balloon. This new device feature will help facilitate tissue manipulation for easier dissection and resection of polyps wi
11/13/18 - Pfizer's Groton facility plays key role in recent FDA approvals [The Day, New London, Conn.]
Nov. 13 GROTON Pfizer Inc. is on a roll, gaining U.S. Food and Drug Administration approval of three anti-cancer drugs in the last two months. As with virtually all Pfizer products, the drugs were developed, in part, at the New York- based pharmaceutical's research and development laboratories on Eastern Point Road in Groton. "Pfizer has enjoy
11/13/18 - STERIBITE Announces FDA Clearance of the Steribite Disposable Kerrison Rongeur
STERIBITE, LLC Chief Executive Officer John A. Redmond offers: "We are extremely pleased with the FDA clearance and know the STERIBITE disposable kerrison will provide a simple, safe and cost effective solution to the problems associated with reusable kerrison rongeurs. STERIBITE, LLC is a privately held medical device company and was developed by
11/12/18 - Cycle Pharmaceuticals Receives Approval for Updated Infant Administration for NITYR (nitisinone) Tablets for HT-1 in U.S.
Cycle Pharmaceuticals is pleased to announce that the U.S. Food and Drug Administration has approved a new version of the NITYR? Prescribing Information including an improvement to the administration procedure for infants using an oral syringe. NITYR? is indicated for the treatment of patients with hereditary tyrosinemia type 1 in combination w
11/12/18 - FDA Approves Merck's KEYTRUDA for the Treatment of Patients with Hepatocellular Carcinoma Who Have Been Previously Treated with Sorafenib
KENILWORTH- Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved KEYTRUDA, Merck' s anti-PD-1 therapy, for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib. Andrew X. Zhu, lead investigator and director of liver cancer
11/12/18 - Newly approved drug Xofluza adds to flu-fighting arsenal [The San Diego Union-Tribune]
That has been the case for Tamiflu, the first pill that people could take to fight flu infection and it's still the case for Xofluza, the new anti-viral medication recently approved by the U.S. Food and Drug Administration. Though the 2018-2019 flu season has so far been mild, and flu shots remain the first-line defense against a threat that killed
11/12/18 - PolyPid Announces FDA Clearance of Investigational New Drug Application (IND) to Commence Pivotal Phase 3 Clinical Trial of D-PLEX[100] for the Prevention of Sternal Wound Infection Post-Cardiac Surgery
PolyPid Ltd., a clinical-stage biopharmaceutical company focused on developing and commercializing novel, locally administered therapies for post-surgical complications, announced today that the United States Food and Drug Administration has completed its review of the IND and indicated that PolyPid may proceed with its phase 3 clinical trial of it
11/10/18 - Bryhali Lotion Is the Latest Psoriasis Drug Approved by the FDA [T-break Tech (Middle East)]
If you suffer from psoriasis a skin condition that affects over 7.5 million people in the United States, according to the American Academy of Dermatology you sure as well know that advances for treatment are huge. For the unfamiliar, psoriasis is a chronic condition in which your body "essentially gets angry at your skin, leading to red, scaly plaq
11/10/18 - Coherus receives US FDA approval for Neulasta biosimilar, pricing 33% lower [T-break Tech (Middle East)]
Coherus BioSciences CEO, Denny Lanfear has told investors that Udenyca, a biosimilar to Amgens Neulasta, will be priced at $4,175. Coherus received approval for its biosimilar from the US Food and Drug Administration at the end of last week. This price tag matches the rate Mylan, alongside Biocon, decided for its own biosimilar, Fulphila, when it l
11/10/18 - Connecticut Department of Consumer Protection: New Condition Approved for Medical Marijuana Program
The Connecticut Department of Consumer Protection issued the following news release:. Yesterday, the Regulations Review Committee of the General Assembly approved a new condition for our state's Medical Marijuana Program. The Food and Drug Administration approved the medication in June and the Drug Enforcement Administration classified the...
11/10/18 - FDA Approves Return Of Non-Prescription Asthma Inhaler After 7 Years [Tehran Times (Iran)]
Seven years after it was removed from the market, over-the-counter asthma inhaler Primatene has been approved by the Food and Drug Administration again. Does the agency have any concerns about the product this time? In 2011, popular OTC asthma inhaler Primatene was removed from the market because it had chlorofluorocarbon propellants, a known...
11/10/18 - The FDA Just Approved a New Flu Treatment for the First Time In 20 Years [Syrian Arab News Agency]
This might help: The Food and Drug Administration just approved the first flu medication in over 20 years: Xofluza. "Xofluza is a one-dose antiviral flu treatment medication meant to be taken within 48 hours of flu symptoms," says Elisabeth Farnum, M.D., associate medical director at Doctor On Demand. "Xofluza works by stopping the virus from mul
11/9/18 - Erchonia & InnerScope Hearing Technologies to Conduct FDA Clinical Trial to Treat Tinnitus with Low Level Laser Technology [Tehran Times (Iran)]
Erchonia Corporation, the global leader in the manufacturing and development of low level laser therapy technology, today announces a joint development agreement with InnerScope Hearing Technologies. The companies have already received approval under FDA regulations from the Institutional Review Board for their initial clinical trial.
11/9/18 - FDA Approves First Drug Using the Recombinant Factor C Assay for Endotoxin Testing
Walkersville- Lonza announced today that the recombinant Factor C Assay has been used for endotoxin testing of Eli Lilly' s Emgality, the first drug approved by the U.S. Food and Drug Administration to have been released using this method instead of traditional Limulus Amebocyte Lysate- based methods. 'The recent FDA approval of Emgality marks a si
Articles(s): 1 - 25 of 42     Next >>     Go To Page:


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