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U.S. FDA Approves Regeneron And Sanofi's Lead Drug For Skin Inflammation In Children
Tuesday, June 7, 2022 - 4:13pm | 235Read More...The U.S. Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi’s (NASDAQ: SNY) lead drug candidate Dupixent (dupilumab) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. The regulatory approval was supported by...
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Boston Scientific's Exalt Model B Single-Use Bronchoscope Wins FDA Approval
Wednesday, August 11, 2021 - 5:34am | 273Read More...The FDA has given 510(k) clearance for Boston Scientific Corp's (NYSE: BSX) Exalt Model B single-use bronchoscope for use in bedside procedures within the intensive care unit and operating room. The device can be used for a wide range of bronchoscopy procedures, including secretion...
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DURECT Shares Soar After FDA Nod For Post-Surgical Pain Medication Posimir
Tuesday, February 2, 2021 - 9:43am | 182Read More...The FDA has granted approval to DURECT Corporation's (NASDAQ: DRRX) POSIMIR (bupivacaine solution), a non-opioid, sustained-release local analgesic for the treatment of post-surgical pain following arthroscopic subacromial decompression surgery (a type of shoulder...
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The Week Ahead In Biotech: Avenue's FDA Decision, Alkermes Adcom Meeting, Aziyo Biologics IPO
Sunday, October 4, 2020 - 9:00am | 754Read More...Biotech stocks made a steady recovery over the week ended Oct. 2, although Friday's weakness trimmed some of the gains of the week. Companies working on anti-COVID-19 antibody treatments were in the news during the week. Sorrento Therapeutics Inc. (NASDAQ: SRNE) announced a second more...
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Thermo Fisher Ships First Batch Of Coronavirus Tests, Plans To Produce 5M Tests A Week By April
Tuesday, March 17, 2020 - 7:16am | 458Read More...Life sciences and healthcare company Thermo Fisher Scientific (NYSE: TMO) shipped the first batch of its novel coronavirus (COVID-19) testing kits to laboratories across the United States by Monday, chief executive officer Marc Casper told CNBC. What Happened Thermo Fisher currently has about 1.5...
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Roche Receives FDA Emergency Approval To Ship 400,000 Coronavirus Test Kits Across US
Monday, March 16, 2020 - 10:32pm | 438Read More...Roche Holding AG (OTC: RHHBY) is shipping COVID-19 test kits approved under emergency use authorization (EUA) by the FDA. What Happened Roche’s Sars-CoV-2 Test for COVID-19 has begun shipping to hospitals and laboratories across the U.S. The test will enable high-volume, automated...
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Epizyme's Tazemetostat Drug For Epithelioid Sarcoma Gets Accelerated FDA Approval
Friday, January 24, 2020 - 5:52am | 313Read More...Biopharmaceutical company Epizyme Inc. (NASDAQ: EPZM) on Thursday said that its tazemetostat drug for the treatment of patients with epithelioid sarcoma had been approved by the Food and Drug Administration. What Happened The TAZVERIK drug has been approved, particularly for the...
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Janney: Nightstar Therapeutics Has 'Significant Upside Potential' With Retinal Disorder Treatments
Wednesday, August 22, 2018 - 9:21am | 410Read More...Nightstar Therapeutics PLC (NASDAQ: NITE) leads the market in adeno-associated virus gene therapy for the treatment of inherited retinal disorders, according to a bullish Janney analyst. The Analysts Analyst Yun Zhong initiated coverage of Nightstar with a Buy rating and $34 price...
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ACADIA Meets Primary Endpoint Alzheimer's Disease Exploratory Study; Stock Rallys
Tuesday, December 20, 2016 - 10:27am | 279Read More...Shares of ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) gained more than 15 percent early Tuesday morning after the company announced positive top-line results from a Phase II study (-019 Study) of its therapy to treat Alzheimer's Disease called pimavanserin. Acadia's therapy has a different...
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Chiasma Plunges 14%; Feuerstein Source Says FDA Will Reject Co.'s Therapy Capsules
Thursday, April 14, 2016 - 9:05am | 258Read More...Shares of Chiasma Inc (NASDAQ: CHMA) plunged more than 14 percent Thursday morning ahead of the U.S. Food and Drug Administration's decision on Friday to approve or reject the company's therapy. Chiasma is a biopharmaceutical company that focuses on the treatment of orphan diseases. The...
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JPMorgan, Canaccord Confident That Vertex's CF Drug Will Get FDA Approval
Wednesday, May 13, 2015 - 12:55pm | 781Read More...On May 12, the FDA advisory committee recommended that the FDA approve Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) Orkambi therapy to treat cystic fibrosis. Shares of Vertex increased nearly 8 percent in pre-market trading following the announcement. The FDA advisory committee provides...
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Market Wrap For December 31: Markets End The Year On A Positive Note
Tuesday, December 31, 2013 - 4:29pm | 1198Read More...As markets completed its final trading day of 2013, investors and traders can look back at what turned out to be a spectacular year for equities. U.S. stocks had its best year in over a decade fueled by an improving economy and the Fed's easy money policies. Commodities on the other hand have...
