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Ipsen Stock Declines After Pulling Rare Disease Application
Friday, August 13, 2021 - 9:48am | 363Read More...Ipsen (OTC: IPSEY) withdrew its US marketing application for palovarotene following discussions with the FDA indicating additional data analyses needed from two pivotal trials. Palovarotene is an oral, selective RARγ agonist to prevent heterotropic ossification (new bone...
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BeyondSpring's Plinabulin US Application for Chemo-Induced Neutropenia Under Review
Tuesday, June 1, 2021 - 10:45am | 140Read More...The FDA has accepted for review BeyondSpring Inc's (NASDAQ: BYSI) marketing application seeking approval for the use of plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN). Under the priority...
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XBiotech To Test New Drug Candidate Combined With Approved Treatment In Pancreatic Cancer
Monday, April 19, 2021 - 6:08am | 284Read More...The FDA has signed off Phase 1/2 clinical study to evaluate XBiotech Inc's (NASDAQ: XBIT) XB2001 when added to the ONIVYDE/5-FU combination therapy for treating patients with pancreatic cancer. The Phase 1 portion of the study will examine increasing doses of XBiotech...
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Akari Therapeutics' To Go With Pivotal Bullous Pemphigoid Study With Nomacopan
Monday, April 12, 2021 - 11:48am | 282Read More...The FDA has opened the investigational new drug application for Phase 3 trial for Akari Therapeutics Plc's (NASDAQ: AKTX) lead drug candidate, nomacopan, for the treatment of moderate and severe Bullous Pemphigoid (BP), allowing clinical sites to open mid-2021, subject...
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Landos Biopharma Stock Is Trading Higher On Initiating Early-Stage Study With Omilancor For Esophagus Inflammation
Tuesday, April 6, 2021 - 8:53am | 304Read More...The FDA has signed off Landos Biopharma's (NASDAQ: LABP) Investigational New Drug application for omilancor (BT-11) for the treatment of Eosinophilic Esophagitis (EoE). Landos expects to initiate patient dosing in the first half of 2022. The 36-subject Phase 1b study is...
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Karyopharm Stock Is Trading Higher After China's NMPA Signs Off Early-Stage ATG-019 Study In Cancer Settings
Tuesday, April 6, 2021 - 5:19am | 217Read More...The National Medical Products Administration (NMPA) has approved Antengene Corporation Limited's Investigational New Drug Application for a Phase 1 trial of ATG-019 in China. The trial will evaluate the safety and tolerability of ATG-019 (monotherapy or combined with niacin ER)...
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Gilead Seeks Full FDA Approval Of Its Remdesivir Drug For Coronavirus
Tuesday, August 11, 2020 - 12:34am | 410Read More...Gilead Sciences, Inc (NASDAQ: GILD) announced Monday it was seeking complete Food and Drug Administration approval for its drug Remdesivir, which is being used in the treatment of COVID-19. What Happened The drugmaker said it has filed a New Drug Application with the FDA on the basis of...
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AstraZeneca Remains Committed To Development Of ZS-9 Despite Letter From FDA
Friday, May 27, 2016 - 6:47am | 267Read More...Shares of AstraZeneca plc (ADR) (NYSE: AZN) were trading lower by more than 1.5 percent early Friday after the company confirmed it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration relating to its New Drug Application (NDA) for sodium zirconium cyclosilicate,...
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Pain Therapeutics Gains 7%, FDA Has Accepted Company's Remoxy For Review
Wednesday, April 13, 2016 - 10:32am | 179Read More...Shares of Pain Therapeutics, Inc. (NASDAQ: PTIE), a micro-cap biopharmaceutical company whose lead drug candidate, REMOXY, is used for the treatment of moderate to severe pain. Pain Therapeutics announced after Tuesday's market close the U.S. Food and Drug Administration determined that its...
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Opko Health Shares Tumble Following CRL Related To Rayaldee NDA
Wednesday, March 30, 2016 - 9:04am | 253Read More...Shares of Opko Health Inc. (NYSE: OPK) were trading lower by more than 9 percent ahead of Wednesday's opening bell after the company disclosed it has received a response from the U.S. Food and Drug Administration (FDA) to its New Drug Application (NDA) for RAYALDEE. The FDA indicated in its...
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Heron Therapeutics Falls 11%, Company Says FDA Has Not Concluded A Scheduled Review
Monday, February 29, 2016 - 10:14am | 176Read More...Heron Therapeutics Inc (NASDAQ: HRTX) announced on Monday that the U.S. Food and Drug Administration (FDA) has not taken any action on its New Drug Application (NDA) for SUSTOL. The FDA informed Heron Therapeutics that it has not yet concluded a review of the NDA despite a January 17, 2016,...
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Spectrum Pharmaceuticals Gains 5% After Company Confirms FDA Review Of New Drug
Friday, February 19, 2016 - 12:03pm | 118Read More...Shares of Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) were trading higher by nearly 5 percent late Friday morning after the company announced that the U.S. Food and Drug Administration (FDA) has accepted its EOquin for New Drug Application (NDA) for review. EOquin (apaziquone for intravesical...
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Catalyst Pharmaceuticals Crashes 50% Following 'Refusal To File' Letter From FDA
Wednesday, February 17, 2016 - 10:16am | 256Read More...Shares of Catalyst Pharmaceuticals Inc (NASDAQ: CPRX) lost nearly half of its value Wednesday morning after the company disclosed it received a "Refusal to File" letter from the U.S. Food and Drug Administration. The "Refusal to File" letter was sent to Catalyst...
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Sarepta Therapeutics Dropped 10% Following FDA News
Monday, February 8, 2016 - 1:01pm | 209Read More...Shares of Sarepta Therapeutics Inc (NASDAQ: SRPT) plunged more than 10 percent on Monday and hit a new 52-week low of $10.60 after the company received a notification from the U.S. Food and Drug Administration. The FDA told Sarepta Therapeutics that it requires additional time to complete its...
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FDA Approves Adamas Pharmaceuticals' Alzheimer's Drug, Shares Soar
Wednesday, December 24, 2014 - 9:26am | 232Read More...The FDA on Wednesday approved a New Drug Application for Adamas Pharmaceuticals Inc's (NASDAQ: ADMS) Namzaric for the treatment of moderate to severe dementia of the Alzheimer's type. Namzaric will be available in two dosage strengths, 28/10 mg and 14/10 mg for patients with severe...
