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543 stories matching this filter · ← front page

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  • ‘Substantially better than before’: Why India has golden opportunity to build on innovative R&D wins
    A string of recent wins on the frontiers of novel drug development could mean that a homegrown innovation industry is within reach.
    Fierce Biotech · 1mo agoNeutral↗ source
  • Nobel laureate Jennifer Doudna unveils AI-driven platform to design novel gene‑editing enzymes
    Jennifer Doudna, the Nobel laureate who co‑invented CRISPR, announced a new AI‑powered platform for creating gene‑editing proteins in a paper published today in Science. The system uses computation…
    Fierce Biotech · 1mo agoPositive↗ source
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Infectious Disease373
Lonza urges biotech firms to prioritize early de-risking to streamline IND path
In a recent interview, Jaime Okray of Lonza highlighted that emerging biotech companies are shifting focus from pure speed to early identification of development risks as they aim for an IND filing…
Fierce Biotech · 1mo agoPositive↗ source
  • Agentic AI poised to reshape clinical development by moving beyond tools to autonomous decision-making
    Earlier this year, a colleague argued that clinical leaders should stop asking whether they have an 'AI strategy', because the question often leads to the wrong conversation. Instead, leaders are…
    Fierce Biotech · 1mo agoPositive↗ source
  • FDA issues early alert on Resmed Astral ventilators due to electrical component failure risk
    The FDA’s Center for Devices and Radiological Health has released an early alert warning about a possible high-risk problem with certain Resmed Astral ventilators. A defective electrical component…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Axiom's stem cell therapy shows zero mortality in phase-1 trial for newborn brain injuries
    Axiom Biosciences reported that its mesenchymal stem cell (MSC) therapy achieved a 0% mortality rate over two years in a phase‑1 study of newborns with severe brain injuries. The nine‑patient trial…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Khong Guan expands recall of glutinous rice balls over possible undeclared peanuts
    Khong Guan Corporation announced an expanded recall of its Glutinous Rice Balls with Black Sesame Filling and Black & White Glutinous Rice Balls with Black Sesame Filling after discovering they may…
    fda recalls · 1mo agoCRLNegative↗ source
  • Baxter issues urgent correction for Volara breathing device circuits due to leak risk
    Baxter has sent an Urgent Medical Device Correction notice to customers using its Volara Positive Pressure Breathing System, advising that all patient circuits be corrected before further use. The…
    fda medwatch · 1mo agoCRLNegative↗ source
  • BIO 2026 in San Diego features executive interviews on biotech trends and opportunities
    The BIO International Convention gathered more than 20,000 life‑science leaders in San Diego, serving as a major forum for biotech discussion. During the event, Fierce conducted a series of video…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Ohio launches $30M Life Science Training Center to boost biomanufacturing workforce
    Ohio’s JobsOhio agency and the Ohio Life Sciences Association announced a public-private training center backed by up to $30 million. The center is intended to create a statewide pipeline of operat…
    Fierce Biotech · 1mo agoPositive↗ source
  • Medtronic recalls Harmony delivery catheter system after tip detachment risk
    Medtronic has issued a recall of certain lots of its Harmony Delivery Catheter System (DCS), which is used to implant the Harmony transcatheter pulmonary valve. The FDA classified the recall as th…
    fda medwatch · 1mo agoCRLNegative↗ source
  • FDA issues early alert on non‑sterile BD ChloraPrep applicators in Medline convenience kits
    FDA CDRH issued an early alert about a potentially high‑risk device issue involving BD ChloraPrep applicators in Medline convenience kits that may not be sterile. Medline sent a letter on June 12…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Medical Action Industries issues recall of convenience kits due to risk of particulate contamination
    The FDA’s Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with a Medical Action Industries convenience kit. The alert says that particulates coul…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Fresenius Kabi issues correction for Ivenix infusion pumps over battery health software bug
    The U.S. Food and Drug Administration has classified a correction for Fresenius Kabi’s Ivenix Large Volume infusion pump as the most serious type of recall. The action does not require removal of t…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Fresenius Kabi urges removal of dropped Ivenix infusion pumps after safety correction
    Fresenius Kabi has issued a safety notice for its Ivenix large-volume infusion pumps. The FDA classified the issue as a Class I recall, the most serious level, because the touchscreen can become un…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Windstone Medical issues correction for non-sterile alcohol prep pads in custom convenience kits
    Windstone Medical Packaging, Inc. has released a correction notice for several custom convenience kits that include Cardinal Health Webcol large alcohol prep pads that were found to be non-sterile.…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Yusol International Foods recalls OLA-OLA Pounded Yam over undeclared milk allergen
    Fayus Inc., operating as Yusol International Foods, announced a voluntary recall of its OLA-OLA Pounded Yam product after discovering that some packages contain sodium caseinate, a milk-derived ing…
    fda recalls · 1mo agoCRLNegative↗ source
  • Chile's Frutas y Hortalizas del Sur recalls frozen organic blueberries over possible E. coli O145 contamination
    Frutas y Hortalizas del Sur S.A., based in San Carlos, Chile, announced a recall of its frozen GreenWise Organic IQF Blueberries (10‑oz) because the product may be contaminated with Escherichia col…
    fda recalls · 1mo agoCRLNegative↗ source
  • Mars Petcare voluntarily recalls two lots of Pedigree high-protein wet dog food over possible metal and plastic contamination
    Mars Petcare US announced a voluntary recall of two lots of Pedigree Can High Protein Chopped Chicken & Duck Flavor wet dog food (13.2 oz) after discovering potential foreign material. The recall…
    fda recalls · 1mo agoCRLNegative↗ source
  • 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 · 1mo 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 · 1mo agoCRLNegative↗ source
  • 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 · 1mo agoCRLNegative↗ 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 · 1mo 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 · 1mo agoRegulatoryNegative↗ source
  • La Ceiba Foods Latin Market Inc. Recalls Cottage Cheese Products Because of Possible Health Risk
    June 26, 2026, – La Ceiba Foods Latin Market Inc. is conducting a recall of Requesón Salvadoreño (Salvadoran Cottage Cheese) and Requesón Mexicano (Mexican Cottage Cheese) products marketed under t…
    fda recalls · 1mo ago↗ source