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Spectrum Pharmaceuticals Inc.'s (SPPI) Poziotinib, proposed for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer harboring HER2 exon 20 insertion mutations, has been denied FDA approval as expected. In September, the FDA Oncologic Drugs...
AbbVie (ABBV) announced Wednesday that the European Commission approved SKYRIZI (risankizumab) for the treatment of moderate to severe active Crohn's disease. It is the first specific interleukin-23 or IL-23 inhibitor in the European Union for the treatment of adults with moderately to severely active...
Marker Therapeutics, Inc. (MRKR) announced the FDA has cleared the Investigational New Drug application for MT-601 for the treatment of patients with locally advanced unresectable or metastatic pancreatic cancer in combination with front-line chemotherapy. The company plans to initiate a multicenter...
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Spectrum Pharmaceuticals Inc.'s (SPPI) Poziotinib, proposed for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer harboring HER2 exon 20 insertion mutations, has been denied FDA approval as expected. In September, the FDA Oncologic Drugs...
BioMarin Pharmaceutical Inc. (BMRN) said the company was recently notified by the FDA that, at this time, the Agency no longer plans to hold an advisory committee meeting to discuss the BLA for ROCTAVIAN that is currently under review for adults with severe Hemophilia A. The FDA granted Regenerative...
AbbVie (ABBV) announced Wednesday that the European Commission approved SKYRIZI (risankizumab) for the treatment of moderate to severe active Crohn's disease. It is the first specific interleukin-23 or IL-23 inhibitor in the European Union for the treatment of adults with moderately to severely active...
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caramelrippleicecream nov24

Weis Markets, Inc., a Mid Atlantic food retailer, has recalled 108 containers of Weis Quality Sea Salt Caramel Ripple Ice Cream citing possible presence of undeclared soy and coconut allergens, the U.S. Food and Drug Administration said. The recalled product comes in 48oz containers that says Weis Quality Sea Salt Caramel Ripple Ice Cream, while the lid says Weis Quality Caramel Caribou Ice Cream

fda nov21

Costa Mesa, California-based Phil's Power Pancake is recalling its pancakes in all 5 varieties citing possible presence of undeclared wheat, the U.S. Food and Drug Administration said. The recalled pancakes come in Mango, Raspberry, Cranberry, Dates, and Chocolate Chip Hempseed varieties.

masonvitamins nove18

Miami Lakes, Florida -based Mason Vitamins Inc. has recalled certain Healthy Sense Daily Multiple with Iron and People's Choice Women's Daily Vitamins with Iron due to inconsistent product labeling, the U.S. Food and Drug Administration said. The recall was due to Vitamin A, Vitamin B12, Vitamin C, Vitamin E and Pantothenic Acid amounts being lower than the declared amount on the label.

chocolatefudgebites nove18

Melville, New York-based Fudgeamentals has recalled one lot of Chocolate Fudge Bites packaged in 8 oz. plastic containers citing undeclared walnuts, the U.S. Food and Drug Administration said. The Chocolate Fudge Bites products may contain Chocolate Walnut Fudge Bites products instead, resulting in the presence of undeclared tree nut (walnut) ingredient.

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Results Date Company Name Ticker Event Indication Outcome
Feb 2023 Apellis Pharmaceuticals, Inc. APLS Top-line 48-week data from phase III PEGASUS trial of EMPAVELI (pegcetacoplan) Paroxysmal nocturnal hemoglobinuria
1H 2023 FibroGen Inc. FGEN Topline data from the LELANTOS-1 Phase 3 study of Pamrevlumab Non-ambulatory Duchenne Muscular Dystrophy (DMD)
1H 2023 FibroGen Inc. FGEN Topline data from the MATTERHORN Phase 3 study of Roxadustat Anemia Associated with Myelodysplastic Syndromes (MDS)
2023 REVOLUTION MEDICINES, INC. RVMD Data from Phase 1/1b monotherapy trial of RMC-6236 Solid tumors
2023 REVOLUTION MEDICINES, INC. RVMD Data from Phase 1/1b monotherapy trial of RMC-6291 KRASG12C-mutant solid tumors
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After a recent lull, U.S. Covid cases and casualties are rising again. A 4 percent increase in Covid-related casualties has been reported in the United States in the last two weeks, according to the New York Times. New cases of coronavirus infection have increased by five percent in the same period.
A new study conducted by researchers at the University of Colorado Cancer Center has revealed that the frequency with which certain cancers come back can be brought down to a certain degree by irradiating certain set of lymph nodes near the tumour rather than all of them together. The study was published...
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The federal data from the 2022 National Youth Tobacco Survey (NYTS) on E-cigarette use among U.S. youth, released on October 6, presents some grim findings. According to the Morbidity & Mortality Weekly Report, more than 2.5 million U.S. youth currently use E-cigarettes.
As we enter the final quarter of the year, let's take a look at some of the regulatory news that made headlines in September and look ahead to what's in store in October.
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Bioelectronics is an emerging area of medicine and the devices based on this approach work by modulating the electrical activity in peripheral and central nerves in order to reduce symptoms and underlying causes of disease. Global business intelligence firm IDTechEx has estimated that the market for bioelectronic medicine could exceed $60 billion by 2029.
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