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1,043 stories matching this filter · ← front page

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  • AstraZeneca says AI has yet to yield clinical candidates but could lower risk in late-stage trials
    AstraZeneca's chief executive Pascal Soriot told reporters that the company's AI‑driven efforts in drug design have not yet produced a candidate that has entered clinical testing. He added that th…
    Endpoints · 16d agoNeutral↗ source
  • Argenx to acquire Forte Biosciences for $2.2 billion, adding anti‑CD122 antibody program
    Argenx announced a $2.2 billion cash transaction to purchase Forte Biosciences, a biotech focused on autoimmune therapies. The acquisition brings Forte's anti‑CD122 monoclonal antibody, which is c…
    Endpoints · 16d agoDealPositive↗ source
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  • Virginia judge orders FDA to revisit Biden-era mifepristone restrictions
    A federal judge in Virginia has ruled that the FDA must reexamine certain restrictions on the abortion medication mifepristone that were put in place during the previous administration. The judge…
    Endpoints · 15d agoRegulatoryNeutral↗ source
  • Fujifilm Biotech CEO warns CDMOs must expand services ahead of looming patent cliff
    Fujifilm Biotechnologies CEO Lars Petersen said drugmakers are gearing up for a looming biopharma patent cliff in 2026, a situation that could pressure revenue streams as key patents expire. He wa…
    Endpoints · 15d agoNeutral↗ source
  • FDA questions efficacy of Capricor's Duchenne muscular dystrophy cell therapy ahead of advisory committee
    FDA reviewers have raised concerns about the efficacy of Capricor's cell therapy for Duchenne muscular dystrophy as the agency prepares for an advisory committee meeting. The agency said it could n…
    Endpoints · 16d agoRegulatoryNegative↗ source
  • MapLight's schizophrenia drug fails primary endpoint in Phase 2, sending stock down over 60%
    MapLight Therapeutics saw its shares tumble more than 60% after a mid‑stage trial showed that its once‑daily schizophrenia candidate did not meet the primary efficacy endpoint, even though the over…
    Endpoints · 16d agoNegative readoutNegative↗ source
  • Schrödinger launches AI agent Bunsen, CEO admits earlier AI skepticism was wrong
    Schrödinger announced the debut of its new AI agent, Bunsen, which is built on the company’s physics‑based software platform. The tool is intended to help biopharma researchers model molecular beha…
    Endpoints · 16d agoPositive↗ source
  • American Regent recalls one lot of Papaverine Hydrochloride injection over glass particles
    American Regent announced a voluntary nationwide recall of a single lot of its Papaverine Hydrochloride Injection, USP 60 mg/2 mL, after detecting visible particulate matter. The particles were id…
    fda medwatch · 16d agoCRLNegative↗ 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 · 16d 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 · 16d 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 · 16d agoRegulatoryNeutral↗ source
  • FDA advisory panel lifts restrictions on six wellness peptides
    The FDA's advisory committee concluded its two-day meeting by voting to remove the existing limits on six widely used health and wellness peptides. Committee members said the vote overrode earlier…
    Endpoints · 16d agoRegulatoryPositive↗ source
  • MapLight’s schizophrenia drug misses primary endpoint in Phase 2, shares tumble over 60%
    MapLight Therapeutics reported results from a mid‑stage Phase 2 trial of its experimental schizophrenia therapy. The study evaluated a once‑daily dosing regimen and failed to meet the predefined p…
    Endpoints · 16d agoNegative readoutNegative↗ 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 · 16d agoNeutral↗ source
  • Sarepta appoints Michael Severino as CEO to steer company beyond a turbulent year
    Sarepta Therapeutics announced that Michael Severino will become its chief executive officer, taking over from longtime leader Doug Ingram. Severino is slated to start on Tuesday and joins the com…
    Endpoints · 16d agoNeutral↗ 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
  • Legend Biotech CEO Ying Huang resigns, Carvykti head Max Gelman appointed interim chief
    Legend Biotech announced that its chief executive officer, Ying Huang, has stepped down after serving in the role since November 2020. Huang's resignation was reported on Friday, marking the end o…
    Endpoints · 16d agoNeutral↗ 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 · 16d agoDealNeutral↗ source
  • Vaisala executive Vesa Pylvänäinen sells 1,582 shares at €56.92 each
    Vaisala Oyj disclosed a transaction by senior executive Vesa Pylvänäinen on July 23, 2026. He disposed of 1,582 ordinary shares of the company on the Nasdaq Helsinki market at an average price of…
    globenewswire health · 16d agoNeutral↗ source
  • Vaisala senior manager Vesa Pylvänäinen disposes 1,582 shares at €56.92 each
    Vaisala Corporation disclosed that senior manager Vesa Pylvänäinen sold a portion of his holdings. The disposal involved 1,582 shares of Vaisala A shares, with a volume‑weighted average price of €…
    globenewswire health · 16d agoNeutral↗ source
  • Nokia senior manager Pallavi Mahajan buys 62,000 shares at $9.55 each
    Nokia disclosed that senior manager Pallavi Mahajan filed a transaction notice under the EU Market Abuse Regulation. The notice, dated July 24, 2026, records Mahajan's purchase of 62,000 Nokia sha…
    globenewswire health · 16d agoRegulatoryNeutral↗ source
  • Nokia senior manager Patrik Hammarén acquires 43,293 shares at €8.44 each
    Nokia Corporation disclosed that senior manager Patrik Hammarén purchased shares of the company. The acquisition was made on July 24, 2026 and involved a total of 43,293 shares at a unit price of…
    globenewswire health · 16d agoRegulatoryNeutral↗ source
  • Nokia board member Timo Ihamuotila reports share purchases across multiple markets on July 24, 2026
    Nokia Oyj disclosed an insider transaction by board member Timo Ihamuotila, filed under the market abuse regulation article 19 as an initial notification. The first purchase was made on the BEUP m…
    globenewswire health · 16d agoNeutral↗ source
  • Nokia board member Timo Ihamuotila purchases 33,700 shares at around €8.45 each
    On July 24, 2026, Timo Ihamuotila, a member of Nokia Corporation's board, executed multiple share purchases. He acquired 24,340 shares on the BEUP venue at a price of €8.4449 per share. Additiona…
    globenewswire health · 16d agoNeutral↗ source
  • Nokia executive Patrik Hammarén reports share purchase of 43,293 shares at €8.44 each
    Nokia Oyj disclosed a leadership transaction filed under market abuse regulation article 19. The filing lists senior executive Patrik Hammarén as the reporting person. The transaction involved a t…
    globenewswire health · 16d agoDealNeutral↗ source