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354 stories matching this filter · ← front page

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  • Latigo Biotherapeutics plans IPO to fund phase 3 trials of non-opioid pain drug LTG-001
    Latigo Biotherapeutics announced it is preparing an initial public offering to raise capital for its clinical-stage, non-opioid pain management pipeline. The company highlighted its oral Nav1.8 in…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Zen Principle Moringa Capsules Recalled Over Possible Salmonella Contamination
    Relay Peak Research LLC, operating as Zen Principle Naturals, announced a voluntary recall of its Zen Principle brand Moringa Leaf Powder Capsules. The recall was triggered by a potential contamin…
    fda recalls · 1mo agoCRLNegative↗ source
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Infectious Disease356
  • Geopolitical uncertainty dampens UK biotech IPO outlook despite record Q2 venture funding
    Geopolitical uncertainty continues to weigh on the sentiment around initial public offerings for British biotech companies, according to an industry leader speaking to Fierce. At the same time, th…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Abbott reports cyberattack on cancer diagnostics and LabCentral portal, says operations unaffected
    Abbott announced that a cyber incident on July 16 accessed a limited number of internal systems in its cancer diagnostics unit. The company said the breach does not affect product availability, ma…
    Fierce Biotech · 1mo agoNegative↗ source
  • Eli Lilly’s $2.8 bn purchase of AtaiBeckley adds psychedelic candidate BPL‑003, sparking optimism for broader mental‑health drug pipeline
    Eli Lilly announced it has acquired AtaiBeckley for $2.8 billion, bringing the privately held biotech’s lead psychedelic program into its portfolio. The deal gives Lilly access to BPL‑003, an intr…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • 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 · 1mo 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 · 1mo agoApprovalPositive↗ source
  • Abbott Beats Q2 Expectations with Strong Device and Diagnostic Sales, Raises Profit Forecast
    Abbott reported second‑quarter results that exceeded analysts' forecasts, easing concerns about potential impact of ACA subsidy cuts on medtech firms. Diagnostics revenue jumped 42% year‑over‑year…
    Fierce Biotech · 1mo agoEarningsPositive↗ source
  • Dimerix acquires Mission's phase-2 ready AKI drug in $292 million deal
    Dimerix announced it has acquired the acute kidney injury candidate MTX652 from Mission Therapeutics in a deal valued at up to $292 million, including a $5 million upfront payment. Mission had com…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • San Diego biotech BlossomHill files for IPO to fund EGFR lung-cancer drug program
    BlossomHill Therapeutics, a San Diego oncology biotech focused on small‑molecule drugs, has filed an S‑1 registration statement to become a public company. The company, founded in February 2024 by…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Jasper Therapeutics merges with Kira Pharmaceuticals, divests Tavneos rival to Mirador
    Jasper Therapeutics announced a merger with Nasdaq‑listed Kira Pharmaceuticals, positioning the combined company for a fresh strategic direction. The deal follows a difficult period for Jasper, whi…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • GSK halts camlipixant development after mixed Phase 3 results curb blockbuster hopes
    GSK announced it is stopping work on camlipixant, a P2X3 receptor antagonist it bought when acquiring Bellus Health in 2023, after the drug produced mixed results in two Phase 3 chronic cough trial…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Biotronik Neuro acquires Soin Neuroscience spinal cord stimulation patent portfolio to boost next-gen pain therapy
    Biotronik Neuro, the neuromodulation arm of Berlin-based medtech firm Biotronik, announced it has purchased a collection of spinal cord stimulation patents from Ohio-based Soin Neuroscience. The a…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Fierce Biotech flags five cities poised to become next biotech powerhouses
    Fierce Biotech’s latest special report identifies five cities that could emerge as major biotech hubs. The podcast episode of “The Top Line” highlights Boston, San Francisco, Beijing, Seattle and C…
    Fierce Biotech · 1mo agoPositive↗ source
  • Taylor Fresh Foods recalls all iceberg lettuce from central Mexico over possible Cyclospora contamination
    Taylor Fresh Foods, operating as Taylor Farms de Mexico in Guanajuato, is voluntarily removing all iceberg lettuce sourced from central Mexico from the U.S. market because of a potential Cyclospora…
    fda recalls · 1mo agoCRLNegative↗ source
  • Takeda's zasocitinib clears scalp psoriasis in 75% of patients in phase 3 data
    Takeda released updated results from its two phase 3 trials of the oral TYK2 inhibitor zasocitinib, enrolling a total of 1,801 patients with moderate-to-severe plaque psoriasis. The data showed th…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • InnoCare’s TYK2 inhibitor soficitinib meets primary endpoint in phase 2 vitiligo trial
    InnoCare Pharma announced that its TYK2 inhibitor soficitinib achieved the primary endpoint in a phase 2 study of non‑segmental vitiligo conducted at sites in China. The trial evaluated daily oral…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Cue Biopharma appoints Dominic Borie as chief medical officer and head of R&D
    Cue Biopharma announced the hiring of Dr. Dominic Borie, MD, PhD, as its new chief medical officer and head of research and development. Borie joins from Kyverna Therapeutics, where he served as a…
    Fierce Biotech · 1mo agoPositive↗ source
  • Khong Guan recalls glutinous rice balls with black sesame filling over possible undeclared peanuts
    Khong Guan Corporation announced a recall of certain lots of its Glutinous Rice Balls with Black Sesame Filling after discovering they may contain undeclared peanuts. The product, sold in 14.1‑oz…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • ‘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
  • 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
  • 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
  • FDA Grants Emergency Use Authorization for Ivermectin Liquid to Prevent New World Screwworm in Horses
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for an ivermectin oral solution intended for horses, aimed at preventing infestations by New World screwworm. The au…
    fda press · 1mo agoRegulatoryNeutral↗ source