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  • FDA Grants Accelerated Approval for Jemperli Immunotherapy in Locally Advanced Rectal Cancer
    The U.S. Food and Drug Administration has granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab‑gxly). The approval applies to adults with previously untreated stage…
    fda press · 19h agoApprovalPositive↗ source
  • Lidl US recalls Gelatelli Coffee & Vanilla Gelato over possible Listeria contamination
    Lidl US announced a recall of one lot of its Gelatelli Coffee & Vanilla Gelato with coffee sauce and cookie pieces, citing potential contamination with Listeria monocytogenes. The affected product…
    fda recalls · 4d agoCRLNegative↗ source
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Nephrology633
  • Osivax shifts to combination strategy after Phase 2b flu vaccine setback
    Osivax, a French biotech, reported that its lead influenza vaccine candidate did not meet primary endpoints in a Phase 2b study. The trial, which evaluated the vaccine as a standalone product, sho…
    Endpoints · 4d agoNegative readoutNegative↗ source
  • FDA expands Anktiva use for BCG-unresponsive high-grade papillary bladder cancer
    The U.S. Food and Drug Administration has broadened the approved use of Anktiva, a therapy given with Bacillus Calmette-Guérin, to treat adults with high-grade papillary-only bladder cancer that ha…
    fda press · 5d agoApprovalPositive↗ source
  • Krasnyi Oktyabr Recalls Starfish Seafood Trio Over Listeria Risk
    Krasnyi Oktyabr Inc. of Brooklyn, New York announced a voluntary recall of its Starfish Seafood Trio, which includes cold smoked salmon, halibut and trout packaged in 8‑oz vacuum‑sealed packs. The…
    fda recalls · 10d agoCRLNegative↗ source
  • Krasnyi Oktyabr Inc. Recalls Starfish Seafood Premium Cold Smoked Norwegian Salmon Sliced (227g/8oz) Because of Possible Health Risk
    Krasnyi Oktyabr Inc. of Brooklyn, New York, is voluntarily recalling STARFISH SEAFOOD PREMIUM COLD SMOKED NORWEGIAN SALMON SLICED (227g/8oz) packages, because the product has the potential to be co…
    fda recalls · 11d ago↗ source
  • Argenx halts Phase 3 Sjögren's trial as celiac disease data brings mixed results
    Argenx disclosed on Thursday that it is ending its Phase 3 trial in Sjögren's syndrome after the study failed to meet its primary endpoint. The decision came alongside the release of encouraging r…
    Endpoints · 12d agoNegative readoutNegative↗ source
  • Gardeners Basics Recalls Waltham 29 Broccoli Sprouting Seeds Due to Possible Salmonella Contamination
    October 8, 2026, Gardeners Basics of Spanish Fork, Utah, is recalling one-pound bags of broccoli sprouting seeds because they may be contaminated with Salmonella, an organism which can cause seriou…
    fda recalls · 11d ago↗ source
  • Nuvig Therapeutics halts Phase 2 trial of NVG-2089 in chronic inflammatory demyelinating polyneuropathy
    Nuvig Therapeutics announced it is terminating one of its two ongoing clinical programs, a Phase 2 study of its candidate NVG-2089. The trial was designed to evaluate NVG-2089 in patients with chr…
    Endpoints · 12d agoCRLNegative↗ source
  • Eden Brothers recalls Calabrese broccoli seeds over possible Salmonella contamination
    Eden Brothers LLC announced a recall of its Calabrese broccoli seeds after being informed by its supplier that the product may be contaminated with Salmonella. The recall includes 1‑ounce and 1‑po…
    fda recalls · 12d agoCRLNegative↗ source
  • Novartis pays $575 million upfront for worldwide rights to Abogen’s CD19xCD3 mRNA T-cell engager
    Novartis announced it will pay Abogen Biosciences $575 million upfront for exclusive worldwide rights to its lead early‑stage CD19xCD3 mRNA T‑cell engager. The agreement gives Novartis access to t…
    Endpoints · 18d agoDealPositive↗ source
  • EAK Distribution recalls Home Grown broccoli seed packets over possible Salmonella contamination
    EAK Distribution LLC announced on October 2, 2026 that it is recalling its 8‑oz Home Grown Green Sprouting Calabrese Broccoli Seeds due to a potential Salmonella contamination. The company warned…
    fda recalls · 17d agoRegulatoryNegative↗ source
  • Frutas y Hortalizas del Sur expands recall to more Great Value and Trader Joe's frozen berry products over E. coli risk
    Frutas y Hortalizas del Sur S.A., a Chilean producer, announced on Oct 2, 2026 that it is expanding its earlier recalls of frozen organic berries. The expansion adds additional lots of Great Value…
    fda recalls · 17d agoCRLNeutral↗ source
  • Sanofi to pay $1 billion upfront to expand antibody partnership with Regeneron
    Sanofi announced it will provide Regeneron with a $1 billion upfront payment to broaden their existing antibody collaboration. The agreement is timed as the patent protection for Dupixent, the joi…
    Endpoints · 19d agoDealNeutral↗ source
  • Gias Foods recalls Bettergoods Lemon Alfredo Fettuccine over possible Listeria contamination
    Gias Foods of New York announced a recall of all lot codes of its Bettergoods Authentic Italian Lemon Alfredo Fettuccine after routine testing indicated possible contamination with Listeria monocyt…
    fda recalls · 19d agoRegulatoryNegative↗ source
  • Former Spark co-founder Steven Altschuler launches new immune-resetting biotech
    Steven Altschuler, who co-founded Spark Therapeutics, has announced the formation of a new biotech that aims to reset the immune system. The venture is positioned to address autoimmune diseases, a…
    Endpoints · 20d agoDealPositive↗ source
  • Nonprofits launch ultra-rare immune disease gene therapy Waskyra at $3.25 million price
    Two nonprofit organizations have received FDA approval for a gene therapy that targets an ultra-rare immune disorder. The therapy, called Waskyra, is now being launched with a list price of $3.25…
    Endpoints · 21d agoApprovalNeutral↗ source
  • Sierra Nevada Cheese Company recalls all Graziers raw milk cheeses over possible E. coli O26:H11 contamination
    Sierra Nevada Cheese Company of Willows, California, announced a voluntary recall of its Graziers Raw Milk Cheese line, which includes Monterey Jack, Jalapeno Jack, Medium Cheddar and Sharp Cheddar…
    fda recalls · 21d agoNegative↗ source
  • Kyverna reports positive one-year CAR-T results for rare stiff person syndrome, supporting FDA filing
    Kyverna Therapeutics announced that its CAR-T therapy for stiff person syndrome showed positive results after one year of treatment. The trial involved patients with the rare autoimmune disorder,…
    Endpoints · 26d agoPositive readoutPositive↗ source
  • Roivant's FcRn drug IMVT-1402 fails Phase 2b lupus trial
    Roivant announced that its FcRn-targeting antibody IMVT-1402 (imeroprubart) failed to meet primary endpoints in a Phase 2b trial in patients with lupus. The study did not show improvement in disea…
    Endpoints · 26d agoNegative readoutNegative↗ source
  • Berlin Seeds recalls 950 lbs of alfalfa sprouting seed over possible STEC and Salmonella contamination
    Berlin Seeds of Millersburg, Ohio announced a recall of 950 pounds of its alfalfa sprouting seed. The recall was triggered because the seed could be contaminated with Shiga toxin‑producing Escheri…
    fda recalls · 26d agoRegulatoryNegative↗ source
  • Cue Biopharma's chronic hives drug clears Phase 2 trial, first immunology data after cancer pivot
    Cue Biopharma announced that its candidate for chronic spontaneous urticaria successfully completed a Phase 2 trial in China. The trial marks the company's first clinical data since it shifted its…
    Endpoints · 29d agoPositive readoutPositive↗ source
  • Two more biotechs, Marea and North Immunology, do reverse mergers
    The reverse merger party is still buzzing. This time, it's a cardio and endocrine startup with two drugs in Phase 2 and a biotech working on a long-acting immunology and inflammation (I&I) drug. Mi…
    Endpoints · 1mo ago↗ source
  • Roche turns to Dualitas to find new bispecific approaches for immunology
    Roche is turning up the heat on its hunt for next-generation bispecific antibodies in a deal that will involve screening 300,000 new combinations for inflammatory and immunology conditions. The Swi…
    Endpoints · 1mo ago↗ source
  • Vera Therapeutics reports two-year data showing Trutakna stabilizes kidney function in IgA nephropathy, paving way for full FDA approval
    Vera Therapeutics announced that its recently approved drug Trutakna has produced encouraging two-year results in patients with IgA nephropathy, a chronic autoimmune kidney disease. The data indic…
    Endpoints · 1mo agoPositive readoutPositive↗ source