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Citius Pharmaceuticals, Inc. (CTXR) announced the FDA has accepted the company's Biologics License Application for denileukin diftitox, an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma. "With an anticipated PDUFA...
Regeneron Pharmaceuticals, Inc. (REGN) said the FDA has accepted for Priority Review the supplemental Biologics License Application for Evkeeza as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia. The FDA target action date...
BioCryst Pharmaceuticals, Inc. (BCRX) announced Monday that the Israeli Ministry of Health has granted marketing authorization for oral, once-daily ORLADEYO (berotralstat) to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older in Israel. Neopharm...
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GSK plc (GSK, GSK.L) reported positive headline results from the planned interim analysis of part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial investigating Jemperli plus standard-of-care chemotherapy followed by Jemperli compared to chemotherapy plus placebo followed by placebo in adult patients...
Citius Pharmaceuticals, Inc. (CTXR) announced the FDA has accepted the company's Biologics License Application for denileukin diftitox, an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma. "With an anticipated PDUFA...
Compugen Ltd. (CGEN) reported publication of abstracts by ESMO-IO showing that at the time of abstract data cutoff, Compugen's COM701 in dual and triple combination with nivolumab ± BMS-986207 showed preliminary anti-tumor activity and immune activation in platinum resistant ovarian cancer patients and...
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Salt Lake City, Utah-based Rocky Mountain Pies, LLC is recalling Red Button Vintage Creamery French Silk Pie citing possible presence of undeclared almonds, a known allergen, the U.S. Food and Drug Administration said. The recall involves 31.88 oz French Silk Pie with the lot code beginning with 2 266. Only UPC code 0 41172 81290 9 is involved in the recall.

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Lenoir, North Carolina -based Exela Pharma Sciences, LLC has expanded its recall of Sodium Bicarbonate Injection due to vial breakage to include more lots, the U.S. Food and Drug Administration said. The product is used for treatment of metabolic acidosis and is packaged in a 50 mL glass vial, 20 vials per carton.

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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

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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.

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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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The United States has reported a 26 percent increase in coronavirus test positivity in the last two weeks. In states such as Arizona, Utah, South Dakota and Missouri, test positivity rates are above 20 percent.
The first-ever high quality study looking into the impact of cannabidiol oil on palliative care patients suffering from advanced cancer found that it did not bring them any relief from their pain, depression, anxiety, or quality of life. Palliative care is one of the conditions for which medicinal cannabis...
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The FDA, which started 2022, on a slow note, has so far approved 30 novel drugs, compared to 47 that were approved during the same period last year. Now, let's take a look at the biotech stocks facing FDA decision in December.
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.
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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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