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3,443 stories matching this filter · ← front page

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  • Optogenetics therapy restores light sensitivity in half of retinitis pigmentosa patients in early trial
    A small clinical study examined an optogenetics‑based approach for treating retinitis pigmentosa, a genetic disorder that progressively destroys retinal light‑sensing cells and often leads to legal…
    STAT · 13d agoPositive readoutPositive↗ source
  • Caribou Biosciences halts CAR-T programs and cuts staff amid funding shortfall
    Caribou Biosciences, a CRISPR gene-editing company co-founded by Nobel laureate Jennifer Doudna, announced it will stop work on its off-the-shelf CAR-T cancer therapies. The decision follows the c…
    BioPharma Dive · 14d agoLayoffsNegative↗ source
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  • ArriVent BioPharma's Phase 3 lung cancer trial misses primary endpoint, shares tumble
    ArriVent BioPharma reported that its investigational EGFR tyrosine kinase inhibitor firmonertinib did not achieve a statistically significant improvement in progression-free survival in the Phase 3…
    BioSpace · 14d agoNegative readoutNegative↗ source
  • Cadrenal Therapeutics launches strategic review to explore sale or partnership for its late-stage cardiology pipeline
    Cadrenal Therapeutics, a heart-focused biotech, announced a strategic review of its late-stage cardiology pipeline, seeking to offload assets or the entire company. The board is evaluating options…
    Fierce Biotech · 14d agoDealNegative↗ source
  • Caribou Biosciences to halt R&D and cut staff as financing for allogeneic CAR-T dries up
    Caribou Biosciences, co‑founded by Nobel laureate Jennifer Doudna, announced it will stop all clinical‑stage work and lay off staff because of a financing freeze in the allogeneic CAR‑T market. Th…
    BioSpace · 14d agoLayoffsNegative↗ source
  • Cerevance reports positive Phase 3 results for Parkinson’s drug solengepras
    Cerevance, a Boston biotech spinout from Takeda, announced that its experimental Parkinson’s drug solengepras achieved its primary endpoint in a Phase 3 trial. The trial enrolled 341 patients with…
    BioPharma Dive · 14d agoPositive readoutPositive↗ source
  • 2026 Nobel Chemistry Prize honors research on chiral molecules with implications for drug development
    Henri B. Kagan, 95, and Kenso Soai, 76, received the 2026 Nobel Prize in chemistry for their work on asymmetric organic synthesis. Their research uncovered how certain reactions can act as their o…
    STAT · 14d agoPositive↗ source
  • Matchpoint Therapeutics raises $150M Series B to advance oral covalent therapies for autoimmune disease
    Matchpoint Therapeutics announced a $150 million Series B financing round. The round was co-led by Nextech Invest and Norwest, with participation from Sanofi Ventures, Digitalis Ventures, Invus, BB…
    Fierce Biotech · 14d agoDealPositive↗ source
  • EMA to revise pharmacogenomics guideline as MHRA adopts AI framework for medical devices
    The European Medicines Agency’s Committee for Medicinal Products for Human Use is preparing a major revision of its 2018 guideline on good pharmacogenomic practices. Regulators say the rapid advan…
    raps · 14d agoRegulatoryNeutral↗ source
  • Trump administration proposes $70,000 fee for OPT program, raising concerns for biotech talent pipeline
    The Department of Homeland Security announced a proposal to charge $70,000 for the Optional Practical Training (OPT) program, which allows international students on F-1 visas to work in the United…
    STAT · 13d agoRegulatoryNegative↗ source
  • PhRMA sues Trump administration over Medicare GLOBE price pilot
    PhRMA filed a lawsuit in the U.S. District Court for the District of Columbia challenging the Trump administration's GLOBE pilot that would tie Medicare Part B drug prices to those in peer nations.…
    STAT · 14d agoRegulatoryNegative↗ source
  • Dutch court blocks Merck's subcutaneous Keytruda sales in eight European countries after Halozyme patent win
    A Netherlands court issued an injunction that stops Merck from marketing its subcutaneous formulation of Keytruda, known as Keytruda Qlex, in eight European markets. The ruling follows a patent in…
    BioPharma Dive · 14d agoRegulatoryNeutral↗ source
  • Dutch court blocks Merck's subcutaneous Keytruda in several European markets
    A Dutch court has ruled that Merck infringed a patent covering a subcutaneous formulation of its cancer drug Keytruda. The decision requires the company to stop manufacturing and marketing that ver…
    STAT · 14d agoRegulatoryNegative↗ source
  • Forbion secures $2.6 billion in its biggest European venture fund to date
    Forbion, a leading European venture capital firm, announced it has closed a $2.6 billion fund, the largest it has raised and among the biggest recent funds in the region. The new capital will be d…
    STAT · 14d agoDealPositive↗ source
  • Biotech VC Forbion raises record €2.3 bn ($2.6 bn) to back 30 high-potential life-science companies
    Forbion announced a record fundraising of €2.3 bn ($2.6 bn) across two new funds, bringing its assets under management to about €7.5 bn ($8.4 bn). The capital will be allocated through the Forbion…
    BioSpace · 14d agoDealPositive↗ source
  • DOJ expands fraud enforcement to include drug and device makers under FD&C Act
    The Justice Department's National Fraud Enforcement Division released a new directive aimed at combating white-collar fraud, highlighting violations of the Federal Food, Drug, and Cosmetic Act. In…
    STAT · 14d agoRegulatoryNegative↗ source
  • ARPA-H launches Surpass program to speed and broaden clinical trials
    The U.S. Department of Health and Human Services announced a new initiative called Surpass, aimed at removing obstacles that slow clinical development and changing how trials are designed and run.…
    Fierce Biotech · 14d agoPositive↗ source
  • Bayer invests $2.2 billion in Ohio to build pharma manufacturing plant
    Bayer announced a $2.2 billion investment to construct a new pharmaceutical manufacturing complex in New Albany, Ohio. The plant will produce drug substances and finished products for oncology, ca…
    BioSpace · 14d agoDealNeutral↗ source
  • TCGX raises $600 million to fund Asian biotech startups
    Investment firm TCGX announced a new $600 million Asia Life Sciences Fund I aimed at supporting biotech companies across the region. The fund will operate separately but in close coordination with…
    Fierce Biotech · 14d agoDealPositive↗ source
  • Atsena reports early efficacy signals for gene therapy ATSN-201 in X-linked retinoschisis trial
    Atsena Therapeutics presented data from the early parts of its Lighthouse gene therapy trial for X-linked retinoschisis (XLRS) at the American Academy of Ophthalmology meeting. The trial administe…
    Fierce Biotech · 14d agoPositive readoutPositive↗ source
  • Experimental exon-skipping drug from Avidity Biosciences shows early improvement in a Duchenne patient
    A recent story follows two teenage boys living with Duchenne muscular dystrophy, a rare and fatal muscle‑wasting condition. While one boy’s health continues to decline, the other, a 12‑year‑old nam…
    STAT · 14d agoPositive↗ source
  • Caribou Biosciences shuts down after failing to fund late-stage CAR-T lymphoma trial
    Caribou Biosciences, a biotech co-founded by Nobel laureate Jennifer Doudna, announced it is shutting down. The closure follows the company's inability to raise the funding required for a Phase 3…
    STAT · 14d agoNegative↗ source
  • Venture capital continues to flow into biopharma in Q3 2026, favoring later-stage and AI-driven companies
    Venture capital funding into biopharma topped $16 billion in the first half of 2026 and kept rising in the third quarter, according to industry sources. Investors remain selective, directing money…
    BioSpace · 14d agoDealNeutral↗ source
  • Stryker appoints Spencer Stiles as CEO, Kevin Lobo to become Executive Chair
    Stryker announced a leadership change, naming Spencer Stiles as the new chief executive officer. Stiles, who has been president and COO, will also join the board. Kevin Lobo, who has led the compa…
    Fierce Biotech · 14d agoNeutral↗ source
  • Utah health AI pilots face regulatory uncertainty as FDA scrutiny looms
    Utah has launched an AI sandbox that allows health-focused artificial-intelligence projects to be tested in real-world settings. The initiative aims to accelerate innovation while monitoring safety…
    STAT · 14d agoRegulatoryNeutral↗ source