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Biopharmaceutical company Phathom Pharmaceuticals, Inc. (PHAT) announced Wednesday that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for vonoprazan as a treatment for adults for the healing of all grades of erosive esophagitis (EE) and relief...
kendamil may25 The U.S. Food and Drug Administration said it has taken steps to make available millions of cans of additional infant and specialty formula to U.S. consumers in the coming months. Under the agency's recent increased flexibilities, British nutrition products maker Kendal Nutricare will send about 2 million cans of infant formula under the Kendamil brand initially to U.S. beginning in June.
Dermavant Sciences, a subsidiary of biopharmaceutical company Roivant Sciences (ROIV), announced Tuesday that the U.S. Food and Drug Administration (FDA) has approved VTAMA (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, indicated for the topical treatment of plaque psoriasis in adults. This...
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Amneal Pharmaceuticals, Inc. (AMRX) announced the FDA has approved the company's Biologics License Application for pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product will be marketed under the name FYLNETRA. FYLNETRA was developed in collaboration with Kashiv Biosciences. It is used...
Reata Pharmaceuticals Inc. (RETA), a clinical-stage biopharmaceutical company, on Thursday, announced that its New Drug Application for Omaveloxolone has been accepted for priority review by the FDA, with a decision date set for November 30, 2022.
SpringWorks Therapeutics, Inc. (SWTX) reported positive topline results from the DeFi trial, a double-blind, placebo-controlled phase 3 trial evaluating nirogacestat, an investigational oral gamma secretase inhibitor, in adult patients with progressing desmoid tumors. The trial met its primary endpoint...
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vanillaicecream may26

Richmond, Utah-based Casper's Ice Cream is recalling its 56 ounce tubs of "Red Button Vintage Creamery Canadian Vanilla Ice Cream" due to undeclared allergen, the U.S. Food and Drug Administration said. According to the agency, a limited number of the product were mispackaged with Burnt Almond Fudge Ice Cream containing undeclared almonds.

multipleproducts may25

The U.S. Food and Drug Administration announced the recall of multiple products that contain the recently recalled Jif Peanut Butter from J. M. Smucker Co. due to Salmonella concerns. Country Fresh, Taher, Inc., Garden Cut, LLC, Mary's Harvest Fresh Foods, Inc., and Coblentz Chocolate Co. have recalled various products made with the Jif peanut butter.

chocolateproducts may24

Cargill, Inc., a privately held food company, is recalling certain chocolate products containing recalled Jif peanut butter due to the potential for salmonella contamination, the U.S. Food and Drug Administration said. The recall involves 795, 8-ounce boxes of Wilbur brand products, such as Milk and Dark Chocolate Covered Peanut Butter Ritz Crackers, Peanut Butter Meltaways...

smokedsalmon may20

Coeurd-Alene, Idaho-based White Cane Smoked Salmon LLC is recalling Wild Alaskan Cooked and Smoked Salmon as it contains undeclared wheat and soy, known allergens, the U.S. Food and Drug Administration said. The affected Alaskan Cooked and Smoked Salmon is packaged in vacuum bag, sold frozen, and there is no lot code or best by date on a package.

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Results Date Company Name Ticker Event Indication Outcome
2H 2022 Geron Corporation GERN Top-line results from phase 3 Clinical Trial of imetelstat (IMerge) Myelodysplastic Syndromes (MDS)
2H 2022 Selecta Biosciences Inc. SELB Topline data from phase III clinical trial of SEL-212 (DISSOLVE I) Chronic refractory gout
2H 2022 Selecta Biosciences Inc. SELB Topline data from phase III clinical trial of SEL-212(DISSOLVE II) Chronic refractory gout
2H 2022 Harmony Biosciences Holdings, Inc HRMY Topline results from phase II clinical trial of WAKIX Myotonic dystrophy in adults
Q3 2022 ABEONA THERAPEUTICS INC. ABEO Topline results from Phase 3 trial of EB-101 (VIITAL) Recessive dystrophic epidermolysis bullosa (RDEB)
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AtriCure is a medical device company offering surgical treatments and therapies for atrial fibrillation, left atrial appendage management and post-operative pain management.
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The Biden Administration has announced the launch of the first federally-supported Test-to-Treat site in the United States, with more planned in the coming weeks. The nation's first federally-supported Test-to-Treat site was officially launched at a clinic in Providence, Rhode Island, on Wednesday. The Test to Treat program can provide faster, easier access to lifesaving Covid-19 treatments. Th
Driven by the highly transmissible subvariants of Omicron in parts of the country, U.S. daily Covid cases crossed the dreaded 100,000 mark for the tenth day this month. With 110,870 new cases reported on Tuesday, the total number of people that have been infected with the killer bug in the country has risen to 83,509,503.
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As another month comes to a close, it's time to take a look back at some of the healthcare sector news that made headlines in May and look ahead to what's in store on the regulatory front in June.
The FDA decision on Amicus Therapeutics' (FOLD) New Drug Application for Miglustat, one of the two components of AT-GAA, proposed for adult patients with Pompe disease, is slated for May 29.
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Shares of Talaris Therapeutics Inc. (TALS) have lost 64% from their 52-week high of $19.82 last June, and trade around $7. Talaris is a late-clinical stage cell therapy company developing a novel, single-dose, investigational cell therapy with potential to transform standard of care in solid organ transplantation and multiple severe immune and non-malignant blood disorders.
Switzerland-based VectivBio is a global, clinical-stage biotechnology company developing innovative treatments for severe rare conditions with significant unmet medical need. The lead drug candidate is Apraglutide, a next-generation GLP-2 analog, which according to the company represents a potential "pipeline in a product" opportunity.
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