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1,424 stories matching this filter · ← front page

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  • NatureBest Precut & Produce recalls jalapeño-containing products over possible Salmonella contamination
    NatureBest Precut & Produce LLC announced a voluntary recall of food items containing jalapeño peppers supplied by Coast Citrus Distributors because of potential Salmonella contamination. The reca…
    fda recalls · 18d agoCRLNegative↗ source
  • Replimune secures FDA approval for Tudriqev, eyes $1.3 bn peak sales in advanced melanoma
    Replimune announced FDA approval of its therapy Tudriqev for patients with advanced melanoma who have progressed after PD-1 treatment. Analysts at BMO Capital Markets project the drug could genera…
    BioSpace · 19d agoApprovalPositive
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Infectious Disease381
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  • Senate introduces BINSA bill to tighten review of China biotech and pharma transactions
    The U.S. Senate has introduced the Biotech Innovation and National Security Act (BINSA), a bill that would tighten oversight of biotech and pharmaceutical transactions involving China. The proposa…
    Endpoints · 19d agoRegulatoryNeutral↗ source
  • FDA schedules September advisory panel to review Grail's cancer test after trial miss
    The FDA announced it will hold an advisory committee meeting in September to examine Grail's multi‑cancer early detection test. The test recently failed to meet its primary endpoint in a large, ra…
    Endpoints · 19d agoRegulatoryNeutral↗ source
  • Biopharma job postings rise 15% in Q2 as layoffs fall and M&A activity picks up
    The Q2 2026 BioSpace report shows a strengthening biopharma job market, with more openings and fewer layoffs compared with the prior year. Job postings on BioSpace were up 15% year-over-year and 1…
    BioSpace · 19d agoPositive↗ source
  • Intellia identifies HLA allele linked to severe liver enzyme spikes in ATTR gene therapy
    In November 2025, a patient died after receiving Intellia Therapeutics' investigational gene silencer for transthyretin amyloidosis, prompting a safety review of the company’s ATTR gene therapy pro…
    BioSpace · 19d agoRegulatoryNeutral↗ 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 · 19d agoDealPositive↗ source
  • FDA outlines inspection overhaul, proposes IND reforms, and greenlights a disputed cancer therapy
    FDA officials announced a plan to restructure the agency’s inspectional operations, aiming to make inspections more efficient and focused. The proposed changes include consolidating regional office…
    raps · 19d agoRegulatoryNeutral↗ source
  • Johnson & Johnson’s Global Chair of Innovative Medicine Jennifer Taubert Announces Retirement
    Jennifer Taubert, who leads Johnson & Johnson Innovative Medicine worldwide, has said she will step down from her role later this year. The company indicated that Tom (last name not disclosed) wil…
    Endpoints · 19d agoNeutral↗ source
  • EMA releases updated guidance on drug shortage prevention plans
    The European Medicines Agency has published a revised guideline aimed at helping marketing authorisation holders develop and keep drug shortage prevention plans for their products. The new guidanc…
    raps · 19d agoRegulatoryNeutral↗ 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 · 18d agoCRLNegative↗ source
  • BioMarin halts development of BMN401 enzyme therapy after mixed Phase 3 results
    BioMarin announced it will stop work on BMN401, an enzyme replacement therapy aimed at treating ENPP1 deficiency, a rare genetic disorder. The decision follows a Phase 3 trial that produced mixed…
    Endpoints · 19d agoNegative readoutNegative↗ source
  • Pfizer exec says China's biotech growth will decelerate as firms hit R&D frontier
    Andrew Baum of Pfizer told Endpoints News that China's rapid biotech progress is expected to slow as companies move into more advanced research and development. He explained that as Chinese firms…
    Endpoints · 19d agoNeutral↗ source
  • Vistagen’s anxiety nasal spray fails to outperform placebo in Phase 2 study
    Vistagen reported results of its Phase 2 trial of the investigational nasal spray fasedienol for social anxiety disorder. The study enrolled 61 patients who were randomly assigned to receive a sin…
    BioSpace · 19d agoNegative readoutNegative↗ source
  • Senior staff purchase company shares, filing 16/2026 shows insider buying
    The company released a corporate announcement stating that several senior employees have bought shares of the firm. The filing, identified as 16/2026, does not provide details on the number of sha…
    globenewswire health · 19d agoNeutral↗ source
  • Company issues corporate announcement on senior employee transaction
    The company released a corporate announcement identified as item 18/2026. The notice indicates that a transaction involving a leading employee has taken place. No further details about the nature…
    globenewswire health · 19d agoNeutral↗ source
  • Replimune’s Tudriqev immunotherapy receives FDA accelerated approval for advanced melanoma
    Replimune announced that the FDA granted accelerated approval for its immunotherapy, now branded Tudriqev, in combination with Bristol Myers Squibb’s Opdivo. The decision follows two earlier reject…
    BioSpace · 20d agoApprovalPositive↗ source
  • Replimune secures FDA accelerated approval for melanoma therapy after two prior rejections
    Replimune, a biotech based in Massachusetts, has received accelerated approval from the U.S. Food and Drug Administration for its melanoma drug. The approval comes after the therapy was rejected tw…
    Endpoints · 20d agoApprovalPositive↗ source
  • Takeda receives FDA approval for Orzeyful, first orexin agonist to treat all symptoms of narcolepsy type 1
    Takeda announced that the U.S. Food and Drug Administration has approved its drug oveporexton, which will be marketed under the name Orzeyful, for the treatment of narcolepsy type 1 in adults. The…
    BioSpace · 20d agoApprovalPositive↗ source
  • Moderna's mRNA flu vaccine mFLUVISA receives FDA approval after earlier filing refusal
    The U.S. Food and Drug Administration initially issued a refusal-to-file letter to Moderna's flu vaccine in February, but a few days later reversed that decision and accepted a revised submission f…
    BioSpace · 20d agoApprovalPositive↗ source
  • Tarsus Pharma to spend $450M upfront acquiring Alkeus to expand its ophthalmology pipeline
    Tarsus Pharmaceuticals announced it will acquire Alkeus Pharmaceuticals, a Phase 3 biotech focused on a Stargardt disease drug, for an upfront payment of $450 million. The deal is intended to broad…
    Endpoints · 20d agoDealPositive↗ source
  • LifeMine Therapeutics secures $263 million in dual venture rounds to advance organ transplant aftercare drug
    LifeMine Therapeutics announced it has raised a total of $263 million through a $75 million Series D and an $188 million Series F round, opting for private financing rather than an IPO. The capita…
    BioSpace · 20d agoDealPositive↗ source
  • FDA approves first drug for type 1 narcolepsy and greenlights mRNA flu vaccine; AstraZeneca and BMS deny merger talks
    The U.S. Food and Drug Administration has granted approval for the first therapy specifically targeting type 1 narcolepsy, marking a milestone for patients with this rare sleep disorder. In a sepa…
    raps · 20d agoApprovalPositive↗ source
  • FDA outlines pilot to speed IND submissions for up to 10 drug programs
    The Food and Drug Administration has released details of a new pilot program designed to accelerate the Investigational New Drug (IND) filing process for selected candidates. The agency plans to w…
    Endpoints · 20d agoRegulatoryNeutral↗ source
  • Teva agrees to $35 million settlement over delayed generic asthma inhalers
    A Massachusetts federal judge approved a settlement involving Teva Pharmaceuticals and several healthcare funds. The agreement sets the payment at $35 million to resolve the dispute. The funds al…
    Endpoints · 20d agoRegulatoryNegative↗ source