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quidel march03 The U.S. Food and Drug Administration is hastening its efforts to make available more at-home testing options in response to the ongoing COVID-19 pandemic. All At-Home Covid-19 Tests being used now are authorized only for emergency use, and not cleared or fully approved by the FDA. The recent granting of EUA for the Quidel Corp.'s QuickVue At-Home COVID-19 Test is one example.
fda march02 The U.S. Food and Drug Administration has approved the marketing of a new robotically-assisted surgical device (RASD) that can facilitate transvaginal hysterectomy in certain patients using minimally-invasive surgical instruments. The Hominis Surgical System of Memic Innovative Surgery Ltd., the U.S. subsidiary of Israeli biotechnology company memic Ltd., has been granted marketing authorization.
AstraZeneca Plc. (AZN.L, AZN) announced Tuesday that the US Food and Drug Administration or FDA informed FibroGen, Inc. that it will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the new drug application for roxadustat. Roxadustat is under regulatory review for...
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pharma 051517 02mar21 Today's Daily Dose brings you news about the regulatory set back of Athenex's oral Paclitaxel and CorMedix's Defencath, ASLAN Pharma's Atopic Dermatitis trial results, FDA panel review of FibroGen's Roxadustat, Morphic Therapeutic's Phase 1 single ascending dose clinical trial of MORF-057, which is in development for the treatment of inflammatory bowel disease, and STRATA Skin's CEO transition.
biotech feb24 Today's Daily Dose brings you news about the earnings date of Adverum, near-term catalyst of bluebird bio, Predictive Oncology's private placement of common stock, and analyst rating of Sunesis Pharma.
biotech feb23 Today's Daily Dose brings you news about disappointing results from Otonomy's phase III trial of OTIVIDEX in Ménière's disease, FDA'S feedback related to BrainStorm's NurOwn cell therapy, Fast Track designation for Celsion's ovarian cancer drug candidate, and upcoming milestone of Clene.
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recall jan25 04mar21

Wilton Brands, a provider of baking and cake decorating products and services, has recalled all lots of six sprinkles products and one kit containing affected sprinkles for possible presence of undeclared milk, a known allergen, the U.S. Food and Drug Administration said. The affected brands of sprinkles include Wilton, Tasty by Wilton, and Holiday Home.

quakerrice march02

Quaker Oats Co., a unit of food and beverages giant PepsiCo, Inc., has recalled 3.03 oz. bags of Quaker Rice Crisps Sweet Barbecue Flavor for the possible presence of undeclared soy ingredients, the U.S. Food and Drug Administration said. The recall involves 4,550 units of Quaker Rice Crisps Sweet Barbecue Flavor with UPC code of 0 30000 31984 0, and best before date of May 29, 2021.

jjistributing 0301

J&J Distributing has recalled various food products citing potential contamination with Listeria monocytogenes or Lm, an organism that can cause serious and sometimes fatal infections. According to the U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS, around 33 pounds of ready-to-eat meat and poultry salads and wrap products have been called back.

medtronic feb25

Medtronic plc has recalled unused Medtronic Valiant Navion thoracic stent graft system globally, according to the U.S. Food and Drug Administration. The Irish medical technology company also informed physicians to immediately cease use of the device until further notice.

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Results Date Company Name Ticker Event Indication Outcome
Mid 2021 4SC AG VSE.F Top-line results from pivotal phase II study of Resminostat Cutaneous T cell lymphoma
Mid 2021 Alnylam Pharmaceuticals Inc. ALNY Initial results from phase III study of Lumasiran (ILLUMINATE-C ) Advanced Primary Hyperoxaluria Type 1
Mid 2021 Clearside Biomedical, Inc. CLSD Initial safety data from the first cohort of phase I/IIa clinical trial of CLS-AX Neovascular age-related macular degeneration (wet AMD)
Mid 2021 Jaguar Health, Inc. JAGX Results from pilot study of Mytesi Chronic Idiopathic Diarrhea in adult non-HIV patients
Mid 2021 Jaguar Health, Inc. JAGX Final results from phase II study of Mytesi(HALT-D) Diarrhea in HER2-positive Breast Cancer Patients
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Social anxiety disorder, also known as social phobia, is one of the most prevalent mental health conditions in the U.S., affecting as many as 20 million Americans. Antidepressants, Benzodiazepines, and Beta Blockers are currently used to treat social anxiety disorder.
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Texas Governor Greg Abbott has lifted restrictions making it mandatory to wear masks and announced that businesses can start operating with 100 percent capacity beginning next week. An executive order that the Republican governor issued on Tuesday, which comes into effect on March 10, rescinds most of the measures he imposed to contain the coronavirus pandemic.
President Joe Biden announced that his administration is on track to have enough anti-coronavirus vaccine supply for every adult in the United States by the end of May. To achieve this target, Johnson & Johnson will work with Merck to expand the production of the single-shot coronavirus vaccine developed by its vaccine division, Janssen Biotech. Biden said he invoked the Defense Production Act
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The Food and Drug Administration approved four new drugs last month. In the year 2020, 104 new drugs were approved by the FDA. Now, let us take a look at the new drugs approved by the regulator in January 2021.
As 2020 draws to a close, it's time to take a look back at some of the regulatory news that made headlines in December and look ahead at what's in store for January 2021. As for the novel drug approvals, 53 drugs secured FDA nod in 2020 compared to 48 in 2019. Let's take a look at the biotech companies whose drugs are at the FDA altar awaiting a decision in January 2021.
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Shares of Black Diamond Therapeutics Inc. (BDTX) are down 46 percent from their all-time high of $46.25, recorded on June 3, 2020, and trade around $24. The company went public on the Nasdaq Global Select Market on January 30, 2020, by setting a public offering at $19.00 per share.
Shares of Annovis Bio Inc. (ANVS) have gained an impressive 76% from their 52-week low of $2.42, recorded last March, and trade around $10.
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