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The U.S. Food and Drug Administration has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 vaccine for people over 65 years of age, healthcare workers, and others at high risk of severe COVID-19.
fda sep22 The U.S. Food and Drug Administration authorized marketing of a software developed by Paige.AI, a provider of AI-based digital diagnostics, which could help pathologists to identify prostate cancer. The software, called Paige Prostate, is the first and only artificial intelligence or AI-based pathology product to receive FDA approval for in vitro diagnostic or IVD use in detecting cancer...
The U.S. Food and Drug Administration has approved Incyte Corp.'s (INCY) Opzelura or ruxolitinib cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with...
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fda sep22 The U.S. Food and Drug Administration authorized marketing of a software developed by Paige.AI, a provider of AI-based digital diagnostics, which could help pathologists to identify prostate cancer. The software, called Paige Prostate, is the first and only artificial intelligence or AI-based pathology product to receive FDA approval for in vitro diagnostic or IVD use in detecting cancer...
AbbVie (ABBV) has submitted an application to the FDA seeking approval for risankizumab-rzaa or SKYRIZI, for the treatment of patients 16 years and older with moderate to severe Crohn's disease. The submission is supported by data from three phase 3 studies - ADVANCE, MOTIVATE and FORTIFY. Crohn's...
Abbott (ABT) announced FDA approval for Portico with FlexNav transcatheter aortic valve replacement system to treat people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery. Portico is a self-expanding TAVR valve with intra-annular leaflets that help provide...
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greenfieldfarms 0922

Green Field Farms Dairy has recalled its Whole Chocolate Milk product as a laboratory analysis indicated that the product was not effectively pasteurized, the U.S. Food and Drug Administration announced. The recall involves 1,242 units of the Whole Chocolate Milk with an expiration date of September 29, 2021.

pfizer sep17

Drug major Pfizer has again expanded the earlier two recalls of its anti-smoking Drug Chantix (Varenicline) in the form of tablets, to now include all the lots, for the potential presence of nitrosamine impurity, N-Nitroso- varenicline, at or above the FDA interim acceptable intake limit (ADI), the U.S. Food and Drug Administration or FDA said in a statement.

kroger sep17

Kroger Co. is recalling its 16-ounce Kroger bagged kale product, produced by Baker Farms, citing the possible contamination with Listeria Monocytogenes, a deadly bacteria, the U.S. Food and Drug Administration said. The recall includes 16-ounce bags of Kroger branded Kale, with the UPC 11110-18170 with a best by date of 09-18-2021.

buurmafarms sep16

Willard, Ohio-based Buurma Farms Inc. is recalling 320 boxes of its Plain Parsley citing possible contamination with Shiga-toxin producing E.coli, the U.S. Food and Drug Administration said. The recall involves Buurma Plain (flat leaf) Parsley with a harvest date of August 30, 2021 from their Gregory, Michigan location.

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Results Date Company Name Ticker Event Indication Outcome
Nov 2021 Inhibrx, Inc. INBX Additional data from phase I trial of INBRX-109 Conventional chondrosarcoma
Q4 2021 ERYTECH Pharma S.A ERYP Initial data from phase II clinical trial of Eryaspase in combination with gemcitabine and carboplatin compared to chemotherapy(TRYbeCA-2) Triple-negative breast cancer
Q4 2021 Windtree Therapeutics Inc. WINT Data from phase 2 global study of Istaroxime Early cardiogenic shock
Q4 2021 Kronos Bio Inc KRON Initial safety, pharmacokinetic and pharmacodynamic data from phase 1/2 clinical trial of KB-0742 MYC-amplified solid tumors
Q4 2021 Cardiff Oncology, Inc. CRDF Data readout from phase II trial of Onvansertib in combination with abiraterone and prednisone Abiraterone-resistant metastatic castrate-resistant prostate cancer
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The company we are profiling today is KalVista Pharmaceuticals Inc. (KALV), which is developing a franchise of oral treatments for HAE - both on-demand and prophylactic HAE drugs.
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The U.S House of Representatives on Tuesday okayed an amendment, which would protect banks that cater to state-legal marijuana businesses against being penalized by federal regulators. The amendment, which is now a part of large-scale defense spending legislation, was passed with a voice vote. With...
Deaths due to coronavirus infection in the United States continue to remain above the 2000-a-day mark for the second consecutive week. The alarming trend was evident in most of the days since September 8, the day when daily Covid deaths in the country crossed the 2000 mark for the first time since February. With 2331 new coronavirus casualties reporting on Tuesday, the national total has increas
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As August draws to a close, let us take a look back at some of the regulatory headlines from that eventful month and look forward to what September has in store.
As July comes to a close, it's time to look back on some of the month's most important news and look forward to what August has in store. In a recent town hall meeting, the US President Joe Biden stated that he expected the FDA to fully approve the COVID-19 vaccines as soon as late August or early September.
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Shares of Inhibrx Inc. (INBX) have lost more than 40% of their value from their all-time high of $50.97, recorded last December, and trade around $29.
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