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g1 therapeutics1 fda 021621 The U.S. Food and Drug Administration approved a new therapy to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for small cell lung cancer when it has spread beyond the lungs. G1 Therapeutics' Cosela (trilaciclib) was approved as the first and only therapy to help protect bone marrow cells from damage caused by chemotherapy.
Medical technology company Becton, Dickinson and Co. or BD (BDX)announced Friday that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a new molecular diagnostic test for both SARS-CoV-2, including variants from the U.K. and South Africa, and Influenza A+B...
Seagen Inc. (SGEN) said Friday that the European Commission has granted marketing authorization for Tukysa or tucatinib in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior...
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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.
biotech feb19 Today's Daily Dose brings you news about the progress in Flexion Therapeutics' pipeline; Immunome's coronavirus research program; Pfizer/BioNTech testing COVID-19 vaccine in pregnant women; and Rigel's deal with Lilly to develop RIPK1 inhibitors.
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urbanremedy feb24

Urban Remedy is recalling a limited number of Almond Maca and Cacao Mocha beverages citing the possible presence of undeclared almonds and cashews, known allergens, according to the U.S. Food and Drug Administration. The California-based producer and retailer of ultra-fresh, organic meals distributed the affected 462 units of beverages in around 25 cities in the state of California.

recall jan25 19feb21

Aaron's Gourmet Smoked Fish is recalling all smoked fish products citing the lack of licensure and regulatory oversight by the state agency, the U.S. Food and Drug Administration said. The affected products are packaged in both glass jars and vacuum-packed plastic bags, and were distributed to Growers Outlet and Berry Good PDX in Portland, Oregon.

adamssecretco feb17

Adamssecret.co has recalled all lots within expiry of Adam's Secret Extra Strength 1500 and Adam's Secret Extra Strength 3000 in the form of capsules, the U.S. Food and Drug Administration or FDA said in a statement. The product is marketed as a dietary supplement for male sexual enhancement.

cauliflowerbiteslitehouse feb17

Undeclared fish (Anchovies), a known allergen, has forced two companies to recall their products, according to the U.S. Food and Drug Administration. Wadena, Minnesota-based Russ Davis Wholesale is recalling certain Kowalski's brand Buffalo Cauliflower Bites with Kowalski's Steakhouse Blue Dressing 22 oz, while Litehouse Inc. is calling back a limited quantity of its Brite Harbor Caesar Dressing.

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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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COVID-19 hospitalizations continue to fall across the United States, albeit at a slower pace in recent days. A total of 55,058 COVID patients are currently admitted in U.S. hospitals, according to COVID Tracking Project. This is the lowest figure since November 6. Almost 20 million Americans, or around 6 percent of the total of population, have so far been fully vaccinated, according to the U.S
As New York's hospitalization and COVID-19 infection rates continue to decline, Governor Andrew Cuomo announced that several industries in the state can resume operations next month. As part of this, New York City's cinema theaters can re-open on March 15. Under the guidelines issued by the Governor, the cinema halls are allowed to reopen by conforming to the following restrictions: Venues are re
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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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