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BioMarin Pharmaceutical Inc. (BMRN) said it has received approval from the U.S. Food and Drug Administration for Label expansion that will allow maximum dose of 60 mg for Palynziq (pegvaliase-pqpz) injection for treatment of adults with Phenylketonuria or PKU. Previously, the maximum dose was 40 mg. Nineteen...
Bristol-Myers Squibb Co.'s (BMY) zeposia has received approval from Health Canada for the treatment of patients with relapsing remitting multiple sclerosis to decrease the frequency of clinical exacerbations, the company said in a statement. zeposia is an oral medication taken daily that helps protect...
Abbott (ABT) presented new interim clinical data results on its ID NOW COVID-19 rapid test. The company said the results confirmed the data submitted to the FDA in March for Emergency Use Authorization and the interim results. A total of 1,003 people were evaluated in the ID NOW COVID-19 interim clinical...
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stockmarkets jan22 13oct20 What's moving these stocks in the pre-market hours today?
biotech oct13 Today's Daily Dose brings you news about FDA declining approval for Avenue Therapeutics/Fortress Biotech's pain drug IV Tramadol, encouraging data from Gilead/ Galapagos' Ulcerative Colitis trial, reports of Surface Oncology receiving a takeover offer from GlaxoSmithKline, and clinical hold slapped by the FDA on Voyager's Huntington's disease trial.
stockmarkets dec27 12oct20 What's moving these stocks in the pre-market hours today?
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meijer oct08

Meijer, a privately-owned retailer, is recalling whole cantaloupe and select cut cantaloupe fruit trays and bowls citing potential risk of Salmonella that causes foodborne illness, according to the Food and Drug Administration. The multi-state recall involves Meijer Brand cantaloupes, as well as Kandy Brand cantaloupes from Aguila, Arizona-based Eagle Produce, LLC.

seneca oct08

Washington-based Seneca Snack Co. is recalling cinnamon flavor apple chips citing possible Salmonella contamination, the U.S. Food and Drug Administration said in a statement. The recall involves Seneca Cinnamon Apple Chips 0.7 ounce Package and 2.5 ounce Package with Individual Package Codes of 26JUN2021 and 28JUN2021, respectively. The company is also calling back Clancy's Cinnamon Apple Chips.

countryfresh 1005

Country Fresh has recalled various cut and sliced fruits distributed mainly by Walmart, citing potential health risk from Listeria monocytogenes, according to the U.S. Food and Drug Administration. In the initial recall, a limited quantity of watermelon chunks from select stores were included. Country Fresh further extended the recall to include various containers of "Freshness Guaranteed" fruits.

fda recall cleaner 100120

DMM Vission is recalling five lots of Cleaner Hand Sanitizer due to potential presence of methanol (wood alcohol), the U.S. Food & Drug Administration said in a statement. The company is yet to receive any reports of adverse events involving the product.

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Date Company Name Ticker Drug Event Outcome Details
04/03/2021 ACADIA Pharmaceuticals Inc ACAD NUPLAZID (sNDA) FDA decision on NUPLAZID for the treatment of hallucinations and delusions associated with dementia-related psychosis
03/31/2021 AVEO Pharmaceuticals, Inc. AVEO Tivozanib (NDA) FDA decision on Tivozanib treatment for relapsed or refractory renal cell carcinoma
03/29/2021 Merck & Co Inc. MRK KEYTRUDA (sBLA) FDA decision on KEYTRUDA for Patients with High-Risk Early-Stage triple-negative breast cancer Based on KEYNOTE-522 Trial
03/27/2021 Bristol-Myers Squibb Co. BMY Idecabtagene vicleucel (BLA) FDA decision on Idecabtagene vicleucel for treatment of adult patients with relapsed and refractory myeloma
03/27/2021 bluebird bio Inc. BLUE Idecabtagene vicleucel (BLA) FDA decision on Idecabtagene vicleucel for treatment of adult patients with relapsed and refractory myeloma
03/17/2021 CytRx Corp. CYTR Arimoclomol (NDA) FDA decision on Arimoclomol for the treatment of Niemann-Pick disease Type C
03/07/2021 Biogen Inc. BIIB Aducanumab (BLA) FDA decision on Aducanumab for Alzheimer's Disease
03/02/2021 KEMPHARM, INC KMPH.OB KP415 (NDA) FDA decision on KP415 for the treatment of attention deficit hyperactivity disorder
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Results Date Company Name Ticker Event Indication Outcome
1H 2021 Retrophin Inc. RTRX Top-line data from 36-week interim endpoint efficacy analysis from pivotal phase III clinical trial of Sparsentan (DUPLEX) Focal segmental glomerulosclerosis
Q1 2021 Otonomy Inc. OTIC Top-line results from phase III trial of OTIVIDEX Ménière's disease
2021 Iovance Biotherapeutics, Inc. IOVA Submission of BLA for Lifileucel Metastatic melanoma
2021 NovoCure NVCR Final data collection from phase 3 pivotal trial of Tumor Treating Fields (METIS) Non-small Cell Lung Cancer patients with Brain metastases
2021 Zealand Pharma A/S ZEAL Results from phase III trial of Glepaglutide Short bowel syndrome
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There have been 8 IPOs in the healthcare sector so far this month in the U.S. stock market. Listed below are the healthcare companies that are going public this week.
Shares of Personalis Inc. (PSNL) closed at an all-time high of $30.52 on Friday (Oct.9, 2020) and that reflects a gain of over 140 percent in 3.5 months after our stock alert.
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The World Health Organization has warned that using the principle of so-called "herd immunity" to control the coronavirus pandemic is unethical and not a strategy that Governments should pursue. Herd immunity is attained when enough people in a community are infected or vaccinated after which a pathogen stops circulating. Top health experts have warned against that method, saying that it would
The United States reported a significantly lower number of coronavirus deaths and infections Monday, when compared to the figures last week. With 41,529 new cases reporting in the last 24 hours, the national total increased to 7804336, as per to Johns Hopkins University's latest data. A total of 315 deaths reported nationally in the last 24 hours is just one third of what was reported in most o
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As of this writing, the FDA has approved 40 novel drugs so far this year compared to just 27 during the same period (Jan-Sep) last year. Now, let's take a look at the biotech stocks facing FDA decision in October.
So far this year, 36 novel drugs have passed muster with the FDA compared to 26 during the same period (Jan- Aug) in 2019. Let's take a look at the companies that await a ruling from the FDA in September.
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Shares of 10x Genomics Inc. (TXG), which closed at an all-time high of $125 on Friday, have gained 64 percent so far this year. It was on this day last year, i.e. on September 12, 2019, that the company made its debut on the Nasdaq Global Select Market by setting a public offering at $39 per share.
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