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353 stories matching this filter · ← front page

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  • Yusol International expands recall of Ola-Ola Pounded Yam to include 2-, 4-, 5-, and 10-lb packages over undeclared milk allergen
    Fayus Inc., operating as Yusol International Foods in Sacramento, announced an expanded recall of its Ola-Ola Pounded Yam product line. The recall now covers 2‑lb, 4‑lb, 5‑lb and 10‑lb packages af…
    fda recalls · 26d agoCRLNegative↗ source
  • FDA approves Lipfendra, first oral PCSK9 inhibitor, to lower LDL cholesterol in adults
    The U.S. Food and Drug Administration has approved Lipfendra (enlicitide), the first oral inhibitor of the PCSK9 protein, for use as an adjunct to diet and exercise in adults with high cholesterol,…
    fda press · 26d agoApprovalPositive
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Infectious Disease315
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  • Taylor Fresh Foods Recalls Iceberg Lettuce from Central Mexico Because of Possible Health Risk
    Taylor Farms de Mexico of Guanajuato, Mexico is voluntarily removing all iceberg lettuce sourced from central Mexico from the U.S. market, because it has the potential to be contaminated with Cyclo…
    fda recalls · 27d ago↗ source
  • Experts: Ending adequate provision would shut down prescription drug ads
    The US Food and Drug Administration’s (FDA) plans to eliminate adequate provision in direct-to-consumer (DTC) prescription drug ads could result in a de facto ban on drug advertising due to the hig…
    raps · 27d ago↗ source
  • Industry wants more clarity on NGS for assessing gene therapy safety
    The pharmaceutical industry has largely endorsed the US Food and Drug Administration's (FDA) guidance on next-generation sequencing (NGS) for assessing the safety of human gene therapy products. Ho…
    raps · 27d ago↗ source
  • This Week at FDA: FDA staff raise concerns about peptide conflicts, top Democrat wants DOGE investigation, and more
    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This wee…
    raps · 27d ago↗ source
  • Khong Guan Corporation Issues Recall of Glutinous Rice Balls With Black Sesame Filling Due to Undeclared Peanuts
    Khong Guan Corporation is recalling specific lots of “Glutinous Rice Balls with Black Sesame Filling” because they may contain undeclared peanuts. People who have an allergy or severe sensitivity t…
    fda recalls · 27d ago↗ source
  • Recon: Lilly to buy psychedelic developer AtaiBeckley for up to $3.8B; FDA approves Merck’s novel cholesterol drug
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 28d ago↗ source
  • Euro Roundup: EMA posts guidance on preventing microbial contamination of non-sterile products
    The European Medicines Agency (EMA) has released guidance on technical and organizational measures that companies should consider to prevent microbial contamination of non-sterile products.
    raps · 28d ago↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…
    raps · 28d ago↗ source
  • Drug repurposing: Stakeholders say FDA should act within its authority, avoid disincentives
    Patient and healthcare industry stakeholders told the US Food and Drug Administration (FDA) that while there are significant opportunities to repurpose existing drugs, the agency should ensure any…
    raps · 28d ago↗ source
  • Khong Guan Corporation Issues Expanded Recall of Glutinous Rice Balls With Black Sesame Filling to Include Black & White Glutinous Rice Balls With Black Sesame Filling Due to Undeclared Peanuts
    Khong Guan Corporation (Union City, CA) is recalling specific lots of “Glutinous Rice Balls with Black Sesame Filling” and “Black & White Glutinous Rice Balls with Black Sesame Filling” in their re…
    fda recalls · 28d ago↗ source
  • FDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in Horses
    The FDA today issued an Emergency Use Authorization (EUA) for Ivermectin Liquid for Horses (ivermectin oral solution) for the short-term prevention of New World screwworm (NWS) infestations (myiasi…
    fda press · 28d ago↗ source
  • Diamantas backtracks on Makary’s policies issued in journal articles
    The acting commissioner of the US Food and Drug Administration (FDA) has clarified that certain policies disseminated in medical journals by former FDA Commissioner Marty Makary are not official ag…
    raps · 29d ago↗ source
  • Experts: Industry to benefit from focused follow-ups, major deficiency letters in MDUFA VI
    Industry experts say the draft commitment letter for the next Medical Device User Fee Amendments (MDUFA VI) program negotiated by the US Food and Drug Administration (FDA) and the medtech industry…
    raps · 1mo ago↗ source
  • FDA Proposes Rule to Modernize Drug Manufacturing Registration
    The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a…
    fda press · 1mo ago↗ source
  • Fayus Inc., dba Yusol International Foods Recalls OLA-OLA POUNDED YAM Due to Undeclared Milk Allergen
    Fayus Inc., doing business as Yusol International Foods (Sacramento, CA) is voluntarily recalling OLA-OLA POUNDED YAM because the product may contain undeclared milk in the form of sodium caseinate…
    fda recalls · 1mo ago↗ source
  • Frutas y Hortalizas del Sur S.A. Initiates Recall of Frozen GreenWise Organic IQF Blueberries Due to Potential E. coli O145 Contamination
    July 3, 2026 – Frutas y Hortalizas del Sur S.A., San Carlos, Chile is recalling frozen GreenWise Organic IQF Blueberries 10 oz. Because it may be contaminated with Escherichia coli O145:H28 (E. col…
    fda recalls · 1mo ago↗ source
  • Voluntary Recall of Two Lots of PEDIGREE® Can High Protein Chopped Chicken & Duck Flavor Wet Dog Food Due to Potential Fraudulent Distribution of Product Which May Contain Foreign Material
    FRANKLIN, Tenn., (July 2, 2026): Mars Petcare US, Inc. is issuing a voluntary recall for two lots of PEDIGREE® Can High Protein Chopped Chicken & Duck Flavor 13.2oz for dogs.
    fda recalls · 1mo ago↗ source
  • Gellert Global Group Issues Allergy Alert on Undeclared Tuna (Fish) in Aldi Brand Fusia Asian Inspirations Kimchi and Tofu Kimbap
    Gellert Global Group of Elizabeth, NJ is recalling 8.1 oz packages of ALDI Brand Fusia Asian Inspirations Kimchi & Tofu Kimbap because they may contain undeclared fish (tuna). People who have an al…
    fda recalls · 1mo ago↗ source
  • FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease
    The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recu…
    fda press · 1mo ago↗ source
  • Kao USA Voluntarily Recalls Some Lots of Oribe Serene Scalp Densifying Shampoo
    CINCINNATI--(BUSINESS WIRE)--Kao USA Inc. (“Kao USA”) today issued a voluntary recall of select lots of its Oribe Serene Scalp Densifying Shampoo (8.5 oz and 33.8 oz) in the U.S. and Canada due to…
    fda recalls · 1mo ago↗ source
  • Eunha Fisheries Co., LTD. Issues Allergy Alert on Undeclared Wheat, Soy, and Sesame in Certain Frozen Olive Flounder Sashimi Products
    July 01, 2026 EUNHA FISHERIES CO., LTD., Busan, Republic of Korea, is recalling certain Sliced Korean Halibut and Flounder Sashimi products because the accompanying soy sauce and vinegar red pepper…
    fda recalls · 1mo ago↗ source
  • FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients
    The U.S. Food and Drug Administration today approved TREGZI, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult pat…
    fda press · 1mo ago↗ source
  • FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing
    FDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufac…
    fda press · 1mo ago↗ source