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searching for Priority review 62 found (229 total)

Blinatumomab (995 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

Astellas Pharma (2,449 words) [view diff] exact match in snippet view article find links to article

"Astellas gains FDA priority review for gastric cancer therapy BLA". July 7, 2023. "Astellas Announces U.S. FDA Grants Priority Review for Zolbetuximab Biologics

Cabazitaxel (947 words) [view diff] case mismatch in snippet view article find links to article

2021. "Jevtana (cabazitaxel) Injection Approved by U.S. FDA After Priority Review" (Press release). Sanofi Aventis. June 17, 2010. Retrieved December

Vocimagene amiretrorepvec/flucytosine (319 words) [view diff] exact match in snippet view article find links to article

therapy vector. By July 2017, the EMA had granted the combination priority review status, and the FDA had granted it Breakthrough Therapy Designation

Belzutifan (1,319 words) [view diff] case mismatch in snippet view article find links to article

original on 26 April 2021. Retrieved 25 April 2021. "Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482)"

Lipoglycopeptide (666 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

Vedolizumab (2,341 words) [view diff] case mismatch in snippet view article find links to article

and ulcerative colitis. On 4 September 2013, vedolizumab was given a Priority Review Status, which functions to expedite potential acceptance to market

MorphoSys (1,363 words) [view diff] exact match in snippet view article find links to article

accepted the Biologics License Application (BLA) for filing and granted priority review for tafasitamab, setting a Prescription Drug User Fee Act (PDUFA) goal

Ceritinib (1,239 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

Von Hippel–Lindau disease (2,101 words) [view diff] case mismatch in snippet view article find links to article

pathway". RAPS (Press release). Retrieved 25 April 2021. "Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482)"

Tesaro (356 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

Cubist Pharmaceuticals (539 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. 30 December 2013. Retrieved

CCR4 (520 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

Gilteritinib (475 words) [view diff] case mismatch in snippet view article find links to article

Administration (FDA). 2018-11-28. Retrieved 2018-11-29. "U.S. FDA Grants Priority Review to Astellas' New Drug Application for Gilteritinib for the Treatment

Atezolizumab (4,160 words) [view diff] exact match in snippet view article find links to article

standard chemotherapy for some people with lung cancer was granted priority review. In August 2018, the FDA updated the prescribing information for atezolizumab

Meropenem/vaborbactam (746 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. [citation needed] In August 2017, the US Food and Drug Administration

Aflibercept (1,883 words) [view diff] case mismatch in snippet view article find links to article

Retrieved 21 May 2024. "U.S. FDA Approves Zaltrap (ziv-aflibercept) After Priority Review for Previously Treated Metastatic Colorectal Cancer" (Press release)

Nintedanib (3,010 words) [view diff] exact match in snippet view article find links to article

disease) in July 2016 until 6 September 2019. The drug was granted priority review designation by the FDA before being approved in the US on 6 September

Friedreich's ataxia (5,038 words) [view diff] exact match in snippet view article find links to article

FDA accepted a new drug application for omaveloxolone and granted it priority review. Omaveloxolone received FDA approval under the brand name Skyclarys

Rett syndrome (6,288 words) [view diff] exact match in snippet view article find links to article

FDA accepted a new drug application for trofinetide and granted it priority review. In March 2023 the drug received FDA approval for treatment of Rett

Ribociclib (1,447 words) [view diff] case mismatch in snippet view article find links to article

Retrieved 24 August 2021. "Novartis LEE011 (ribociclib) granted FDA Priority Review for first-line treatment of HR+/HER2- advanced breast cancer" (Press

Hypoxia-inducible factor (4,911 words) [view diff] case mismatch in snippet view article find links to article

pathway". RAPS (Press release). Retrieved 25 April 2021. "Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482)"

Vorinostat (1,442 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

Daratumumab (1,722 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 U.S. Food and Drug Administration (FDA) for multiple

Priority (Pointer Sisters album) (395 words) [view diff] exact match in snippet view article

– art direction and design Mark Hanauer – photography Hanson, Amy. Priority review at AllMusic. Retrieved 2011-11-12. Hepworth, David. "Albums". Smash

Small-cell carcinoma (5,452 words) [view diff] case mismatch in snippet view article find links to article

doi:10.1093/annonc/mdz278. PMC 6857609. PMID 31504118. "FDA Grants Priority Review to Trilaciclib to Treat Patients with SCLC". Cancer Network. 17 August

Duvelisib (1,345 words) [view diff] case mismatch in snippet view article find links to article

February 2019. "FDA Accepts New Drug Application for Duvelisib and Grants Priority Review" (Press release). Verastem. 2018-07-07. Archived from the original

Carfilzomib (1,730 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"

Vestronidase alfa (771 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

Orthopoxvirus (1,823 words) [view diff] exact match in snippet view article find links to article

an effectively extinct mechanism of action. The decision followed a priority review by the agency, motivated by growing concern of potential bioweapon

Lurbinectedin (1,473 words) [view diff] exact match in snippet view article find links to article

Drug Administration (FDA) granted the application for lurbinectedin priority review and orphan drug designations and granted the approval of Zepzelca to

Genentech (3,361 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

Alimera Sciences (881 words) [view diff] exact match in snippet view article find links to article

Iluvien new drug application to the FDA in June 2010 and was granted priority review in August 2010. In December 2010, November 2011, and October 2013 the

Setmelanotide (1,407 words) [view diff] exact match in snippet view article find links to article

orphan disease designation, breakthrough therapy designation, and priority review. The FDA granted the approval of Imcivree to Rhythm Pharmaceutical

Aducanumab (4,868 words) [view diff] case mismatch in snippet view article find links to article

aducanumab Biologics License Application (BLA) on 7 August 2020 with a Priority Review. In November 2020, a panel of outside experts on the FDA's Peripheral

Lifitegrast (575 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

Synageva (794 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

Radium-223 (1,914 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

Merck & Co. (9,333 words) [view diff] case mismatch in snippet view article find links to article

"FDA Accepts Merck's Biologics License Application (BLA) and Grants Priority Review for V920, the Company's Investigational Vaccine for Ebola Zaire Virus"

Progeria (6,089 words) [view diff] case mismatch in snippet view article find links to article

2 years. The drug, given orphan drug status and Pediatric Disease Priority Review Voucher, is taken twice daily in the form of capsules and may cost

Empagliflozin (3,481 words) [view diff] exact match in snippet view article find links to article

for heart failure. The FDA granted the application for empagliflozin priority review and granted the approval of Jardiance to Boehringer Ingelheim. As of

Juno Therapeutics (828 words) [view diff] case mismatch in snippet view article find links to article

authors list (link) U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol-Myers Squibb’s Biologics License Application (BLA) for Lisocabtagene

Neurocrine Biosciences (1,289 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

Artesunate (2,874 words) [view diff] exact match in snippet view article find links to article

artesunate or quinine. The application for IV artesunate was granted priority review and orphan drug designations. The FDA granted approval of artesunate

Takeda Oncology (1,244 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

Lumasiran (1,171 words) [view diff] exact match in snippet view article find links to article

designations. In addition, the manufacturer received a rare pediatric disease priority review voucher. The FDA granted the approval of Oxlumo to Alnylam Pharmaceuticals

Prescription Drug User Fee Act (3,146 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

Brent Lee Metcalfe (1,270 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

Cancer immunotherapy (9,943 words) [view diff] exact match in snippet view article find links to article

Annual Meeting" (Press release). Globe Newswire. Roche. "FDA grants priority review for Roche's cancer immunotherapy atezolizumab in specific type of lung

Rita F. Redberg (1,113 words) [view diff] case mismatch in snippet view article find links to article

Cardiovascular Devices Approved Under the Food and Drug Administration Priority Review Program. JAMA Intern Med. 2018 Oct 01; 178(10):1418-1420. PMID 30178044

Tissue-agnostic cancer drug (600 words) [view diff] exact match in snippet view article find links to article

approved by the FDA in November, 2018. Selpercatinib (LOXO-292) received priority review in September 2018 and was approved for medical use in the United States

Catalyst Pharmaceuticals (1,470 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. Archived from the original on December

Cannabis in New Jersey (6,221 words) [view diff] exact match in snippet view article find links to article

rules established three types of cannabis businesses that will receive priority review and approval in application processes: Social equity businesses - owned

Prescription drug prices in the United States (11,701 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

Guardianship of the Islamic Jurist (21,801 words) [view diff] no match in snippet view article find links to article

with the best `political and jurisprudential` vision should have the priority.` "Review by Hossein Modarressi, by The Just Ruler or the Guardian Jurist: An

Treatment of Rett syndrome (3,050 words) [view diff] exact match in snippet view article find links to article

Trofinetide was submitted to the FDA in mid 2022 and accepted for priority review. McCauley MD, Wang T, Mike E, et al. (December 2011). "Pathogenesis

CASBEE (1,593 words) [view diff] exact match in snippet view article find links to article

respondents also indicated a desire for more incentives, specifically priority review of CASBEE projects and financial incentives for building owners. The

List of acts of the 113th United States Congress (197 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

List of acts of the 114th United States Congress (757 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

Wonder Egg Priority (7,689 words) [view diff] case mismatch in snippet view article find links to article

2022-09-12. Retrieved 2022-09-11. Cimi, Chris (2021-04-07). "Wonder Egg Priority Review: Anime Excellence, But at What Cost?". OTAQUEST. Archived from the

Helixmith (1,203 words) [view diff] exact match in snippet view article find links to article

afforded by the fast track and breakthrough designations, including priority review, to Engensis. Helixmith currently has multiple target indications under

Mosiah priority (2,177 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, doi:10.2307/44796961