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The U.S. Food and Drug Administration has broadened the Emergency Use Authorization or EUA for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir, Eli Lilly and Co. (LLY) and Incyte (INCY) said in a statement...
Viatris Inc. (VTRS) and Biocon Biologics said that they received an approval from the U.S. Food and Drug Administration for the first Interchangeable Biosimilar Semglee (insulin glargine-yfgn injection) for the treatment of diabetes. The interchangeable Semglee product, which will allow substitution...
The U.S. Food and Drug Administration has approved Merck & Co., Inc.'s (MRK) anti-PD-1 therapy, KEYTRUDA, for the treatment of patients with high-risk early-stage triple-negative breast cancer or TNBC in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant...
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AbbVie (ABBV) announced Wednesday that the U.S. Food and Drug Administration granted a Breakthrough Therapy Designation or BTD to venetoclax (VENCLEXTA) in combination with azacitidine in Higher Risk Myelodysplastic Syndrome or MDS. The BTD is granted for the potential treatment of adult patients...
Immunome Inc. (IMNM) said that its three-antibody cocktail (IMM-BCP-01) has neutralized the SARS-CoV-2 Delta variant in pre-clinical pseudovirus testing. In Tuesday pre-market trading, IMNM was trading at $21.03 up $4.39 or 26.38%. In addition, the antibody cocktail showed in-vitro activity via...
pfizer july20 Drug major Pfizer is recalling twelve lots of Chantix (Varenicline) Tablets, a treatment to help patients quit smoking, citing the presence of a nitrosamine impurity, N-nitroso-varenicline, above the established Acceptable Daily Intake or ADI level. The U.D. Food and Drug Administration noted that the recall involves two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets,...
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mccormick july28

Flavor maker McCormick & Co., Inc. is recalling certain McCormick and Frank's brand seasoning products citing possible salmonella risk, the U.S. Food and Drug Administration said. The recall involves McCormick Perfect Pinch Italian Seasoning, McCormick Culinary Italian Seasoning and Frank's RedHot Buffalo Ranch Seasoning.

recall aug21 27jul21

The U.S. Food and Drug Administration announced recall of Old Soul's Farms LLC's certain leafy green products as well as Excalibur Seasoning Co.'s Haen Meats Seasoning Blend, citing potential contamination with Listeria monocytogenes, an organism. Consumption of food contaminated with L. monocytogenes can cause listeriosis, a serious infection and sometimes fatal infections.

grimmwayfarms july23

Grimmway Farms has issued a recall of certain carrot products citing the potential to be contaminated with Salmonella, the U.S. Food and Drug Administration said. The recall involves carrot products sold in various brands, such as Bunny Luv, Cal-Organic, Grimmway as well as O Organics. The products were shipped directly to retailers throughout the United States.

liparifoods july22

Warren, Michigan -based Lipari Foods is recalling 86 cases of Troyer Manufacturing Backroad Country Dried Apricots citing the possible presence of undeclared sulfites, the U.S. Food and Drug Administration said. The affected dried apricots are in a clear, plastic-film bag with the Backroad Country Label on the front.

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Results Date Company Name Ticker Event Indication Outcome
Q4 2021 Cortexyme Inc CRTX Top-line data from Phase 2/3 clinical trial of COR388 (GAIN trial) Mild to moderate Alzheimer's disease dementia
Q4 2021 Trevi Therapeutics TRVI Topline data from phase IIb/III clinical trial of Nalbuphine ER (PRISM) Severe pruritus associated with prurigo nodularis
Q4 2021 Sierra Oncology, Inc. SRRA, DNAI Top-line data from phase III trial to confirm efficacy of Momelotinibl ( MOMENTUM) Myelofibrosis symptoms, transfusion independence, and splenomegaly
Q4 2021 9 METERS BIOPHARMA, INC. NMTR Topline results from phase 1b/2a clinical trial of NM-002 Short bowel syndrome
Q4 2021 Daré Bioscience, Inc DARE Topline data from Phase 2b study of Sildenafil Cream (3.6%) Female sexual arousal disorder
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Shares of Nurix Therapeutics Inc. (NRIX) are down 37% from their all-time high of $52.38, set on Dec.14, and trade around $32.
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Cryo-electron microscopy and nuclear magnetic resonance spectroscopy are the new names making headlines in the cancer research community as scientists look to unlock new horizons in cancer treatment. A paper published in Nature, shows how scientists at Mayo Clinic have found out that cancer cells...
The Delta variant of coronavirus spreading across the United States at an alarming pace is apparently causing more severe illness and as easily contagious as chickenpox, U.S. media reported citing an internal document from the US Centers for Disease Control and Prevention. The CDC presentation reportedly says that a Delta variant-positive person will have the potential to infect an average of eig
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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.
As June draws to a close, it's time to take a look back on some of the month's top news stories related to FDA approval and look ahead to what July has in store.
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Shares of Nkarta Inc. (NKTX) have lost more than 170% of their value since reaching a 52-week-high of $79.16 in December, and now trade around $28.
Shares of Fusion Pharmaceuticals Inc. (FUSN) have more than halved from their 52-week high of $18.50, recorded last June, to trade around $8. The company made its debut on the Nasdaq Global Market on June 26, 2020, offering its shares at a price of $17 each.
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