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searching for Priority review 44 found (107 total)

alternate case: priority review

Toca 511 and Toca FC (304 words) [view diff] exact match in snippet view article find links to article

gene therapy vector. By July 2017 the EMA had granted the combination priority review status, and the FDA had granted it Breakthrough Therapy Designation
Vestronidase alfa (600 words) [view diff] exact match in snippet view article find links to article
designation, and a rare pediatric disease priority review voucher. This was the twelfth rare pediatric disease priority review voucher issued. The U.S. Food and
Blinatumomab (947 words) [view diff] exact match in snippet view article find links to article
Amgen's Biologics License Application for blinatumomab was granted priority review designation by the FDA, thus establishing a deadline of 19 May 2015
Atezolizumab (2,045 words) [view diff] exact match in snippet view article find links to article
standard chemotherapy for some patients with lung cancer was granted priority review. In September 2018, it was announced that atezolizumab prolongs survival
Ceritinib (1,167 words) [view diff] case mismatch in snippet view article find links to article
accepted a supplement New Drug Application for ceritinib and granted Priority Review for expanded use of ceritinib. Specifically, it became a first-line
Vedolizumab (2,150 words) [view diff] case mismatch in snippet view article find links to article
ulcerative colitis. On September 4, 2013, vedolizumab was given a Priority Review Status, which functions to expedite potential acceptance to market
Tesaro (298 words) [view diff] exact match in snippet view article find links to article
whom had a PhD or MD. The company's product Niraparib was granted priority review and was given a target action date of June 2017 by the FDA. In March
Pralatrexate (709 words) [view diff] case mismatch in snippet view article find links to article
T-cell Lymphoma”. [2], FDA, “Fast Track, Accelerated Approval and Priority Review”. Andrew Pollack (December 4, 2009). "Questioning a Cancer Drug That
CCR4 (473 words) [view diff] exact match in snippet view article find links to article
(3): 1764–8. doi:10.1074/jbc.273.3.1764. PMID 9430724. FDA grants priority review to mogamulizumab for cutaneous T-cell lymphoma Nov 2017 Human CCR4
Meropenem/vaborbactam (553 words) [view diff] exact match in snippet view article find links to article
title of the FDA Safety and Innovation Act and therefore received priority review. In August 2017, the US Food and Drug Administration approved it to
Lifitegrast (483 words) [view diff] exact match in snippet view article find links to article
and Drug Administration (FDA) in March 2015. The FDA granted Shire a priority review a month later, and requested additional clinical data, which were supplied
Ribociclib (1,090 words) [view diff] case mismatch in snippet view article find links to article
COT.0000444043.33304.c1. "Novartis LEE011 (ribociclib) granted FDA Priority Review for first-line treatment of HR+/HER2- advanced breast cancer". Novartis
Priority (album) (310 words) [view diff] exact match in snippet view article
photography Sal Bonafede and Jerry Weintraub – management Hanson, Amy. Priority review at AllMusic. Retrieved 2011-11-12. Hepworth, David. "Albums". Smash
Nintedanib (2,557 words) [view diff] exact match in snippet view article find links to article
2021. The US Food and Drug Administration (FDA) granted nintedanib priority review designation and granted the approval of Ofev to Boehringer Ingelheim
Cubist Pharmaceuticals (690 words) [view diff] case mismatch in snippet view article find links to article
"Cubist Announces FDA Acceptance of Tedizolid New Drug Application with Priority Review | FierceBiotech". www.fiercebiotech.com. Retrieved 2017-10-31. Kennedy
Daratumumab (894 words) [view diff] exact match in snippet view article find links to article
and 16 mg/kg at monthly to weekly intervals. Daratumumab was given priority review status by the FDA for multiple myeloma as a combination therapy (second
Vorinostat (1,091 words) [view diff] case mismatch in snippet view article find links to article
Medicine for Advanced Cutaneous T-Cell Lymphoma (CTCL), To Receive Priority Review from U.S. Food and Drug Administration" (Press release). Merck & Co
Cabazitaxel (817 words) [view diff] case mismatch in snippet view article find links to article
2011-02-02. "Jevtana (cabazitaxel) Injection Approved by U.S. FDA After Priority Review" (Press release). sanofi-aventis. 2010-06-17. Retrieved June 17, 2010
Alimera Sciences (844 words) [view diff] exact match in snippet view article find links to article
New Drug Application (NDA) to the FDA in June 2010 and was granted priority review in August 2010. In December 2010, November 2011, and October 2013 the
Genentech (2,958 words) [view diff] case mismatch in snippet view article find links to article
age-related macular degeneration (AMD). The FDA approved LUCENTIS after a Priority Review (six-month). Genentech started shipping product on June 30, 2006, the
Carfilzomib (1,734 words) [view diff] case mismatch in snippet view article find links to article
Beacon. Retrieved 2012-02-27. "Fast Track, Accelerated Approval and Priority Review; Accelerating Availability of New Drugs for Patients with Serious Diseases"
Varenicline (2,317 words) [view diff] exact match in snippet view article find links to article
Cytisine analogs led to varenicline at Pfizer. Varenicline received a "priority review" by the US FDA in February 2006, shortening the usual 10-month review
Duvelisib (566 words) [view diff] case mismatch in snippet view article find links to article
September 2018. "FDA Accepts New Drug Application for Duvelisib and Grants Priority Review". 2018-07-07. Carroll, John (24 September 2018). "Unwanted by AbbVie
Lipoglycopeptide (613 words) [view diff] exact match in snippet view article find links to article
infections. As part of its QIDP designation, dalbavancin was given priority review, which provides an expedited review of the drug's application. dalbavancin's
Synageva (795 words) [view diff] case mismatch in snippet view article find links to article
License Application (BLA) for Kanuma, granted Synageva's request for Priority Review, and established a target action date of September 8, 2015 under the
Takeda Oncology (992 words) [view diff] exact match in snippet view article find links to article
comparing a Velcade-based regimen to a traditional standard of care. Priority review was granted by the FDA in January 2008. On June 20, 2008, the FDA approved
List of phase III cancer clinical trials, 2017 (33 words) [view diff] no match in snippet view article find links to article
novartis.com/news/media-releases/novartis-lee011-ribociclib-granted-fda-priority-review-first-line-treatment https://clinicaltrials.gov/ct2/show/NCT02004522
Pembrolizumab (4,277 words) [view diff] exact match in snippet view article find links to article
other chemotherapeutic agents. In July 2016, the US FDA accepted for priority review an application for recurrent or metastatic head and neck squamous cell
Tissue-agnostic cancer drug (205 words) [view diff] exact match in snippet view article find links to article
Larotrectinib was approved by the FDA in November, 2018. Loxo-292 received priority review in September 2018. Other drugs under development include Entrectinib
List of phase III cancer clinical trials, 2016 (27 words) [view diff] no match in snippet view article find links to article
Year 2014 – 2015 – 2016 – 2017 https://www.novartis.com/news/media-releases/novartis-lee011-ribociclib-granted-fda-priority-review-first-line-treatment
Glycogen storage disease type II (3,408 words) [view diff] exact match in snippet view article find links to article
falls under the FDA Orphan Drug designation and was approved under a priority review.[citation needed] The FDA has approved Myozyme for administration by
Neurocrine Biosciences (1,264 words) [view diff] exact match in snippet view article find links to article
October 2017, AbbVie and Neurocrine announced that the FDA granted priority review for the elagolix NDA. A final regulatory decision on the drug will
Radium-223 (1,713 words) [view diff] exact match in snippet view article find links to article
bone metastases and without known visceral disease. 223Ra received priority review as a treatment for an unmet medical need, based on its ability to extend
Prostate cancer (17,541 words) [view diff] exact match in snippet view article find links to article
Administration (FDA) on May 15, 2013, ahead of schedule under the priority review program. Alpharadin still waits for approval by the European Medicines
Gilteritinib (373 words) [view diff] case mismatch in snippet view article find links to article
Prescribing information for XOSPATA (gilteritinib) "U.S. FDA Grants Priority Review to Astellas' New Drug Application for Gilteritinib for the Treatment
Prescription Drug User Fee Act (3,086 words) [view diff] exact match in snippet view article find links to article
normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted 6 months to review the drug. These time frames
Cancer immunotherapy (8,118 words) [view diff] exact match in snippet view article find links to article
Clinical Oncology Annual Meeting". Globe Newswire. Roche. "FDA grants priority review for Roche's cancer immunotherapy atezolizumab in specific type of lung
Prescription drug prices in the United States (9,211 words) [view diff] exact match in snippet view article find links to article
end of 2014. The slow pace of the FDA review (6–12 months even for a priority review) has not allowed the market to correct itself in a timely manner, i
Brilacidin (2,587 words) [view diff] exact match in snippet view article find links to article
approval and marketing pathway, including fast track designation and priority review for development and a five-year extension of market exclusivity. Initial
List of acts of the 113th United States Congress (185 words) [view diff] exact match in snippet view article find links to article
December 16, 2014 Adding Ebola to the FDA Priority Review Voucher Program Act To expand the program of priority review to encourage treatments for tropical
Mosiah priority (2,013 words) [view diff] no match in snippet view article find links to article
Books. ISBN 978-1-56085-230-8. Roper, Matthew (1994), "A More Perfect Priority?", Review of Books on the Book of Mormon, 6 (1): 362–78, retrieved 2014-01-09
List of acts of the 114th United States Congress (763 words) [view diff] exact match in snippet view article find links to article
Adding Zika Virus to the FDA Priority Review Voucher Program Act To expand the tropical disease product priority review voucher program to encourage treatments
Catalyst Pharmaceuticals (2,481 words) [view diff] case mismatch in snippet view article find links to article
December 9, 2019. "NDA for Catalyst's LEMS Therapy Firdapse Accepted with Priority Review". Lambert-Eaton News. June 4, 2018. Retrieved December 9, 2019. Abutaleb
Mesoblast (4,493 words) [view diff] exact match in snippet view article find links to article
JR-031, in children and adults in Japan. JR-031 was granted orphan drug priority review. If successful, it will be the first allogeneic cell-based product