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  • FDA clears Freenome's SimpleScreen CRC blood test, Abbott to market it in U.S.
    The U.S. Food and Drug Administration has given clearance to Freenome’s SimpleScreen CRC, a blood-based test for colorectal cancer. Abbott will be the exclusive U.S. marketer and will pay Freenome…
    Fierce Biotech · 24d agoApprovalPositive↗ source
  • Global HIV funding drops 18%, raising fears of epidemic resurgence
    A new UNAIDS report warns that the world could see a rebound of HIV infections after donor financing fell sharply last year. Government contributions dropped by more than $1.5 billion to $7.3 bill…
    STAT · 23d agoNegative↗ source
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  • Claris Biotherapeutics raises $118M Series B to advance corneal stem-cell eye drop
    Claris Biotherapeutics announced a $118 million Series B financing round led by Novo Holdings and supported by several venture firms. The funding will be used to move its lead candidate, CSB-001, i…
    Fierce Biotech · 23d agoDealPositive↗ source
  • RA Capital backs Oak Hill Bio's Nasdaq debut via $175 million SPAC merger
    RA Capital announced that its SPAC, Research Alliance Corporation III, will merge with Oak Hill Bio, creating a new Nasdaq-listed rare-disease company. The combined entity will start with $175 mil…
    Fierce Biotech · 24d agoDealPositive↗ source
  • Argenx to acquire Forte Biosciences for $2.2 billion, securing phase-2 vitiligo antibody FB102
    Argenx announced it will buy Forte Biosciences for $2.2 billion, gaining access to FB102, an anti‑CD122 antibody currently in phase‑2 trials for vitiligo and celiac disease. In a recent phase 1b s…
    Fierce Biotech · 24d agoDealPositive↗ source
  • PhRMA pushes back as prescription drug spending continues to rise, according to STAT+ newsletter
    STAT+ Health Care Inc. newsletter author Bob Herman reports on the growing concern that prescription drug spending is rising despite industry attempts to downplay it. The piece appears in the July…
    STAT · 23d agoNegative↗ source
  • FDA doubts efficacy of Capricor’s Duchenne stem-cell therapy after Phase 3 miss
    The U.S. Food and Drug Administration said Monday that Capricor Therapeutics’ stem‑cell treatment for Duchenne muscular dystrophy failed to meet the primary goals of its Phase 3 trial, contradictin…
    STAT · 24d agoRegulatoryNegative↗ source
  • FDA advisory panel backs broader compounding of six peptide drugs despite limited safety data
    An FDA advisory panel reviewed seven peptide therapies and voted to ease access to six of them. The recommendation would let compounding pharmacies manufacture these peptides, expanding how they ca…
    STAT · 24d agoRegulatoryPositive↗ source
  • RA Capital leads $175 million round for Oak Hill Bio to revive Roche’s Angelman syndrome drug
    RA Capital and other investors have committed $175 million to Oak Hill Bio, a new biotech aiming to revive a previously shelved experimental therapy for Angelman syndrome originally developed by Ro…
    STAT · 24d agoDealNeutral↗ source
  • Apnimed targets up to $160 million IPO to fund launch of Oxnimbi, its oral sleep apnea pill
    Apnimed, a Massachusetts biotech, filed with the SEC indicating it will seek an IPO of up to $160 million to finance the commercial launch of its oral obstructive sleep apnea therapy, Oxnimbi (AD10…
    Fierce Biotech · 24d agoDealPositive↗ source
  • MapLight shares tumble over 60% after mixed Phase 2 schizophrenia trial results
    MapLight Therapeutics reported mixed outcomes from its Phase 2 Zephyr trial of the experimental schizophrenia drug ML-007C-MA, causing its stock to fall sharply. The trial enrolled 307 patients wi…
    Fierce Biotech · 24d agoNegative readoutNegative↗ source
  • InnoCare’s oral TYK2 inhibitor fadeucravacitinib meets primary endpoint in phase 3 psoriasis trial
    InnoCare Pharma announced that its oral TYK2 inhibitor fadeucravacitinib (also known as ICP-488) achieved the primary endpoint in a phase 3 study of adults with moderate-to-severe plaque psoriasis.…
    Fierce Biotech · 24d agoPositive readoutPositive↗ source
  • Argenx to acquire Forte Biosciences for $2.2 billion, bolstering its autoimmune drug pipeline
    Argenx announced it will purchase Dallas-based Forte Biosciences for $2.2 billion in cash. The transaction values Forte at $77 per share, a 41 percent premium to its closing price on Friday. The a…
    STAT · 24d agoDealPositive↗ source
  • WHO publishes first interim list of medical device authorities; AstraZeneca explores AI to reduce late-stage risk
    The World Health Organization has issued its first interim list of medical device authorities, marking a step toward greater transparency in device regulation. The list is intended to guide manufac…
    raps · 24d agoRegulatoryNeutral↗ source
  • EMA commits to safeguarding stakeholder data; FDA advisory panel expands compounding peptide list
    The European Medicines Agency announced that it will assume ultimate responsibility for protecting information submitted by stakeholders through online meeting registrations and surveys, in line wi…
    raps · 24d agoRegulatoryNeutral↗ source
  • FDA issues three new guidances to expand eligibility criteria for cancer trials
    The FDA's Oncology Center of Excellence has released three final guidance documents aimed at widening the pool of patients who can enroll in oncology clinical trials. The guidances focus on three…
    raps · 24d agoRegulatoryNeutral↗ source
  • Sarepta Therapeutics appoints Michael Severino, former Tessera CEO, as new chief executive
    Sarepta Therapeutics announced that Michael Severino will become its chief executive, effective Tuesday. Severino previously led Tessera Therapeutics. He replaces Doug Ingram, who said he will ret…
    STAT · 24d agoNeutral↗ source
  • Gossamer ends $486M PAH partnership with Chiesi after phase 3 miss
    Gossamer Bio announced it is terminating its collaboration and licensing agreement with Italy's Chiesi, regaining worldwide development and commercial rights to its pulmonary arterial hypertension…
    Fierce Biotech · 24d agoDealNegative↗ source
  • AstraZeneca says it remains confident in its ADC pipeline after dropping two underperforming candidates
    AstraZeneca executives told Fierce they are very confident in their internally developed antibody‑drug conjugate (ADC) program despite recent setbacks. The company has discontinued two ADC candida…
    Fierce Biotech · 24d agoNegative readoutNeutral↗ source
  • Labcorp unveils direct-to-consumer genetic health panel covering 163 genes and 100+ conditions
    Labcorp announced the launch of a new direct-to-consumer test called the Marker by Labcorp Genetic Health Panel. The panel examines 163 genes to assess risk for more than 100 hereditary conditions…
    Fierce Biotech · 24d agoPositive↗ source
  • Study shows drug development and reimbursement timelines align across four major markets
    Researchers published a cross‑sectional analysis in JAMA Health Forum examining how long it takes for a drug to move from the start of clinical trials to receiving reimbursement approval. The anal…
    raps · 24d agoNeutral↗ source
  • FDA panel backs compounding pharmacies to make two peptides, rejects third
    The U.S. Food and Drug Administration’s advisory committee met on Friday and issued recommendations on the manufacturing of certain peptide drugs by compounding pharmacies. Committee members voted…
    STAT · 24d agoRegulatoryNeutral↗ 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 · 24d agoRegulatoryNeutral↗ source
  • Nokia executive Pallavi Mahajan purchases 62,000 shares at $9.55 each
    Nokia reported an insider transaction by Pallavi Mahajan, a member of the senior management team. The filing indicates Mahajan bought 62,000 Nokia shares on July 24, 2026, at a price of $9.55 per…
    globenewswire health · 24d agoDealNeutral↗ source
  • Legend Biotech CEO Ying Huang resigns, interim leader Alan Bash appointed
    Legend Biotech announced that its chief executive, Ying Huang, Ph.D., stepped down on Friday, with no permanent successor named yet. The board named Alan Bash as interim CEO on July 23, according…
    Fierce Biotech · 24d agoNeutral↗ source