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  • Abiomed recalls Impella CP Sets with SmartAssist over low purge pressure risk
    Abiomed has issued a recall of specific Impella CP Sets with SmartAssist after discovering that the units do not meet design specifications. The defect can cause low purge pressure events from the…
    fda medwatch · 2mo agoCRLNegative↗ source
  • Hamilton Medical issues updated use instructions for certain breathing circuit sets after serious recall
    Hamilton Medical has sent a letter to customers on May 18, 2026, advising updated use instructions for specific coaxial breathing circuit sets used with its HAMILTON-C1, HAMILTON T-1 and HAMILTON-M…
    fda medwatch · 2mo agoCRLNegative↗ source
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Psychiatry & CNS887
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Endocrinology & Metabolism494
Infectious Disease457
  • Gellert Global Group recalls ALDI Fusia Kimchi & Tofu Kimbap over undeclared tuna
    Gellert Global Group of Elizabeth, NJ announced a recall of 8.1-oz packages of ALDI's Fusia Asian Inspirations Kimchi & Tofu Kimbap because they may contain undeclared tuna. The undeclared fish po…
    fda recalls · 2mo agoCRLNegative↗ source
  • FDA Grants First Gene-Therapy Approval for Children 2+ with Sickle Cell Disease
    The U.S. Food and Drug Administration issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged two years and older who have sickle cell disease with recurrent vaso-oc…
    fda press · 2mo agoApprovalPositive↗ source
  • Kao USA issues voluntary recall of select Oribe scalp shampoo lots over bacterial contamination
    Kao USA announced a voluntary recall of select lots of its Oribe Serene Scalp Densifying Shampoo in the United States and Canada after detecting the bacterium Pluralibacter gergoviae. The recall a…
    fda recalls · 2mo agoRegulatoryNegative↗ source
  • Eunha Fisheries recalls frozen halibut and flounder sashimi after undisclosed wheat, soy, sesame found in condiment packets
    On July 1, 2026, Eunha Fisheries Co., Ltd. of Busan, South Korea announced a recall of certain sliced Korean halibut and flounder sashimi products. The recall covers items that were sold in the Uni…
    fda recalls · 2mo agoRegulatoryNegative↗ source
  • FDA approves Tregzi, first T‑reg cell therapy to lower chronic GVHD risk in blood‑cancer transplants
    The FDA announced approval of Tregzi, a regulatory T‑cell based immunotherapy designed to improve chronic graft‑versus‑host disease‑free survival for adults with blood cancers undergoing allogeneic…
    fda press · 2mo agoApprovalPositive↗ source
  • FDA picks seven firms for PreCheck pilot to boost U.S. drug manufacturing
    The FDA announced on June 29, 2026 that seven companies have been chosen for its PreCheck Pilot Program, an initiative aimed at strengthening U.S. drug manufacturing and supply chain resilience. T…
    fda press · 2mo agoRegulatoryPositive↗ source
  • La Ceiba Foods recalls Salvadoran and Mexican cottage cheese over possible Listeria contamination
    La Ceiba Foods Latin Market Inc. announced on June 26, 2026 that it is recalling its Requesón Salvadoreño (Salvadoran cottage cheese) and Requesón Mexicano (Mexican cottage cheese) products sold un…
    fda recalls · 2mo agoRegulatoryNegative↗ source
  • FDA proposes rule to require foreign tobacco makers to register and list products, aiming to curb illegal imports and protect youth
    The U.S. Food and Drug Administration announced on June 26, 2026 a proposed rule intended to strengthen its ability to identify illegal foreign tobacco products, including youth‑appealing e‑cigaret…
    fda press · 2mo agoRegulatoryPositive↗ source
  • FDA approves first generic single-dose baloxavir tablet for flu treatment and prevention
    FDA announced approval of the first generic version of Xofluza (baloxavir marboxil) tablets, a single-dose treatment for acute uncomplicated influenza and prophylaxis for patients five years of age…
    fda press · 2mo agoApprovalPositive↗ source
  • FDA approves OTC naloxone nasal spray Rextovy, expanding consumer access to overdose treatment
    The FDA announced approval of a new over-the-counter naloxone nasal spray called Rextovy, delivering 4 mg of naloxone hydrochloride for emergency reversal of opioid overdose. The product can be pu…
    fda press · 2mo agoApprovalPositive↗ source
  • FDA grants accelerated approval for Tzield to delay insulin loss in children with newly diagnosed Stage 3 type 1 diabetes
    The U.S. Food and Drug Administration issued an accelerated approval on June 12, 2026 for Tzield (teplizumab) to slow the decline of insulin production in pediatric patients aged 8 to 17 who have r…
    fda press · 2mo agoApprovalPositive↗ source
  • FDA clears Dexcom's Stelo as first OTC continuous glucose monitor for children
    The U.S. Food and Drug Administration cleared Dexcom's Stelo Glucose Biosensor System for over-the-counter use in children two years of age and older who do not use insulin. This is the first OTC…
    fda press · 3mo agoApprovalPositive↗ source
  • FDA grants emergency use authorization for generic Nitenpyram tablets to treat New World screwworm in dogs and cats
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for generic Nitenpyram tablets to treat New World screwworm infestations in dogs, puppies, cats and kittens that weig…
    fda press · 3mo agoRegulatoryPositive↗ source
  • FDA adds bemotrizinol, first new sunscreen ingredient in 20 years
    The U.S. Food and Drug Administration has approved bemotrizinol as a new active ingredient for over‑the‑counter sunscreens, marking the first addition to the sunscreen monograph since the late 1990…
    fda press · 3mo agoRegulatoryPositive↗ source
  • FDA releases draft guidance to speed cell and gene therapy approvals
    The FDA announced a draft guidance aimed at helping developers bring gene therapies to patients more quickly. It encourages use of publicly available scientific data and existing platform knowledge…
    fda press · 3mo agoRegulatoryNeutral↗ source
  • FDA releases draft guidance to trim animal testing in cancer drug development
    The FDA's Oncology Center of Excellence announced a draft guidance aimed at reducing unnecessary animal studies in the nonclinical safety assessment of certain oncology drugs. The guidance suggest…
    fda press · 3mo agoRegulatoryPositive↗ source
  • FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
    Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarr…
    fda press · 3mo agoApprovalPositive↗ source
  • FDA issues warning letters to eight retailers for selling unauthorized tobacco products that mimic candy and other everyday items
    The U.S. Food and Drug Administration announced on May 20, 2026 that it has sent warning letters to eight retailers for offering unauthorized nicotine pouches and dissolvable tobacco products that…
    fda press · 3mo agoRegulatoryNegative↗ source
  • Preoperative intravesical mitomycin C cuts NMIBC recurrence risk by 77% over five years
    A recent study evaluated giving two doses of intravesical mitomycin C before transurethral resection of bladder tumor (TURBT) in patients with non‑muscle‑invasive bladder cancer (NMIBC). Compared…
    onclive · 3mo agoPositive readoutPositive↗ source
  • High TMB, GBD and PD-L1 Levels Linked to Better Response in Neoadjuvant Gem-iDRS or Cetrelimab Trial for Bladder Cancer
    The SunRISe-4 trial evaluated neoadjuvant gemcitabine‑based immunotherapy with or without cetrelimab in patients with muscle‑invasive bladder cancer. A biomarker sub‑analysis showed that patients…
    onclive · 3mo agoPositive readoutPositive↗ source
  • Expert reviews real-world data on BCG retreatment after failure in non-muscle-invasive bladder cancer
    Dr Joshua J. Meeks, MD, PhD, provided an overview of a real-world study that examined the use of BCG retreatment in patients with non‑muscle‑invasive bladder cancer (NMIBC) who had previously faile…
    onclive · 3mo agoNeutral↗ source
  • Multidisciplinary quality program shown to cut side effects of androgen deprivation therapy in prostate cancer
    Dr Hafron discussed a recent study that evaluated a multidisciplinary quality initiative aimed at reducing adverse events linked to androgen deprivation therapy for prostate cancer. The program co…
    onclive · 3mo agoPositive readoutPositive↗ source
  • FDA approves trastuzumab deruxtecan for early-stage HER2-positive breast cancer
    The U.S. Food and Drug Administration has granted approval for trastuzumab deruxtecan (T‑DXd) as a treatment option in both the adjuvant and neoadjuvant settings for certain patients with early-sta…
    onclive · 3mo agoApprovalPositive↗ source