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39 stories matching this filter · ← front page

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  • Whole Foods recalls dips, salsas and other prepared foods containing jalapeños over possible Salmonella risk
    Whole Foods Market announced a recall of select produce and prepared-food items that contain jalapeños supplied by Coast Citrus Distributors because of a potential Salmonella contamination. The re…
    fda recalls · 4h agoCRLNegative↗ source
  • Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing ICU Medical Pain Management Components
    Medline is correcting affected convenience kits by removing included ICU Medical pain management components containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP.
    fda medwatch · 17h ago↗ source
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Psychiatry & CNS669
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Ophthalmology329
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Infectious Disease314
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 1d agoLayoffsNegative↗ source
  • MoonLake reports all endpoints met in phase 3 trial of sonelokimab for psoriatic arthritis
    MoonLake Immunotherapeutics said its lead nanobody sonelokimab achieved positive topline results in a phase 3 study of patients with psoriatic arthritis. At week 16, 42.1% of participants reached…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
  • Fresenius Kabi recalls Tyenne (tocilizumab-aazg) 400 mg injection vials over glass particle contamination
    Fresenius Kabi announced a recall of a specific lot of its Tyenne (tocilizumab-aazg) injection, 400 mg/20 mL vials, after detecting glass particles in the product. The company said the contaminati…
    fda recalls · 2d agoCRLNegative↗ source
  • Latigo and BlossomHill file Nasdaq IPO plans to fund pain and cancer pipelines
    Latigo Biotherapeutics and BlossomHill Therapeutics, both based in California, have filed applications to list on the Nasdaq Global Select Market. Latigo aims to raise up to $285.2 million to advan…
    BioSpace · 2d agoDealNeutral↗ source
  • Taylor Fresh Foods recalls jalapeño-containing products over possible Salmonella contamination
    Taylor Fresh Foods announced a recall of finished products that contain jalapeño peppers after being notified of a voluntary recall by Coast Citrus Distributors due to potential Salmonella contamin…
    fda recalls · 3d agoRegulatoryNegative↗ source
  • BlossomHill and Latigo Biotherapeutics raise over 30% beyond IPO targets
    Two emerging biotech companies surpassed their initial public offering expectations on Friday, with both BlossomHill Therapeutics and Latigo Biotherapeutics raising at least 30% more capital than p…
    Fierce Biotech · 5d agoDealPositive↗ source
  • BlossomHill and Latigo close IPO week with $496 million raised
    BlossomHill Therapeutics, a cancer‑focused biotech, completed its initial public offering this week. Latigo, a company developing non‑opioid pain treatments, also went public at the same time. To…
    Endpoints · 5d agoDealPositive↗ source
  • Lexunder’s Food to Live green powder recalled over possible Salmonella contamination
    Lexunder Inc., operating as Food to Live, announced a recall of its green powder products due to potential Salmonella contamination. The recall covers products sold nationwide in resealable pouche…
    fda recalls · 4d agoCRLNegative↗ source
  • Braveheart Bio targets $382 million IPO to fund cardiac drug development
    Braveheart Bio announced an upsized initial public offering on the Nasdaq, aiming to raise about $382.5 million. The company will sell 21.2 million shares at $18 each under the ticker BRVE. The pr…
    BioSpace · 6d agoDealPositive↗ source
  • Eli Lilly posts $23 B Q2 revenue, beats forecasts as Foundayo lags behind Novo's oral GLP-1
    Eli Lilly reported second‑quarter revenue of $23 billion, a 48% increase from the prior year and well above analysts' expectations. The strong top‑line helped the company deliver a sizable earnings…
    BioSpace · 7d agoEarningsNeutral↗ source
  • Lilly and FDA clash over retatrutide classification as company nears submission
    Eli Lilly is preparing to file its obesity drug candidate retatrutide for approval while a legal dispute with the FDA over the drug's classification intensifies. The agency has concluded that reta…
    BioSpace · 7d agoRegulatoryNeutral↗ source
  • Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes
    Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product. The recall stems from a labeling mistake where the MicroVault contain…
    fda recalls · 8d agoCRLNegative↗ source
  • Latigo Biotherapeutics targets non-opioid pain market with $247 M IPO
    Latigo Biotherapeutics announced details of its planned initial public offering, aiming to raise roughly $247 million to advance its pipeline of non-opioid pain treatments. The company intends to…
    Fierce Biotech · 8d agoDealPositive↗ source
  • Analyst warns AstraZeneca-BMS merger could spark regulatory hurdles and job cuts
    Angus Liu writes an editorial warning that talks of a merger between AstraZeneca and Bristol Myers Squibb could create more problems than benefits. He notes that the two companies have only discuss…
    Fierce Biotech · 9d agoDealNegative↗ source
  • Medline orders correction of convenience kits containing lidocaine and bupivacaine in dextrose injection
    Medline has issued a correction for certain convenience kits that include lidocaine hydrochloride and bupivacaine hydrochloride mixed with dextrose injection. The FDA has classified this recall as…
    fda medwatch · 9d agoCRLNegative↗ source
  • Boticelli Foods recalls Bettergoods pistachio nut butter over possible Salmonella contamination
    Boticelli Foods of Melville, New York announced a recall of one lot of Bettergoods Pistachio Nut Butter, a 6.7‑oz (190 g) product identified by UPC 194346207961 and lot number LB028ACP04. The reca…
    fda recalls · 9d agoRegulatoryNegative↗ source
  • Latigo Biotherapeutics reports non-opioid drug cuts acute pain in Phase 2b trial
    Latigo Biotherapeutics announced that its experimental non-opioid analgesic demonstrated a reduction in acute pain in a Phase 2b clinical trial. The study results suggest the candidate may offer a…
    Endpoints · 12d agoPositive readoutPositive↗ source
  • American Regent recalls two lots of Adequan canine injection and two lots of Adequan i.m. for horses due to glass fibers
    American Regent Animal Health announced a nationwide recall of specific lots of its Adequan products for dogs and horses. The recall includes two lots of the 100 mg/mL 5 mL multi‑dose canine injec…
    fda recalls · 12d agoCRLNegative↗ source
  • Argon Medical issues correction for convenience kits containing lidocaine ampules after FDA safety alert
    Argon Medical has sent a correction notice to customers about certain convenience kits that include lidocaine HCl ampules supplied by Spectra Medical Devices. The FDA has classified this correctio…
    fda medwatch · 13d agoCRLNegative↗ source
  • Australia's TGA adopts 23 international scientific guidelines from EMA, ICH and FDA
    The Therapeutic Goods Administration (TGA) in Australia announced it has formally adopted 23 scientific guidelines. The guidelines come from the European Medicines Agency, the International Counci…
    raps · 16d agoRegulatoryNeutral↗ source
  • FDA advisory panel recommends adding peptides BPC-157 and KPV to bulk compounding list
    An FDA advisory committee voted 8-6, with one abstention, to recommend that two experimental peptides – BPC-157 for ulcerative colitis and KPV for wound and inflammatory conditions – be placed on t…
    raps · 19d agoRegulatoryNeutral↗ source
  • FDA advisory panel adds six peptides to compounding bulk drug list, rejects one
    The FDA’s advisory committee concluded a two-day meeting on Friday, reviewing seven peptide drug substances for inclusion on the agency’s bulk-drug compounding list. Committee members voted to add…
    raps · 19d agoRegulatoryNeutral↗ source
  • Eli Lilly’s retatrutide meets primary goals in phase 3 obesity trials with ~22% weight loss but no clear heart benefit
    Eli Lilly reported that its triple‑hormone agonist retatrutide achieved the primary endpoints in two phase 3 obesity studies, TRIUMPH‑2 and TRIUMPH‑3. The drug was tested at a 12 mg dose against pl…
    Fierce Biotech · 20d agoPositive readoutNeutral↗ source