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3,393 stories matching this filter · ← front page

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  • BioNTech spends $205 million on FDA priority review voucher to accelerate oncology pipeline
    BioNTech has agreed to pay $205 million to acquire an FDA priority review voucher, a tool that can shorten the agency's standard review period from ten months to six months. The voucher was previo…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Study proposes new obesity metric that could reverse diagnoses for millions, aiming for more precise care
    Researchers published a study in Nature that suggests an alternative way to define obesity could change the diagnosis status for millions of people. The proposed framework separates pre-clinical an…
    STAT · 23h agoNeutral↗ source
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  • PepGen stock surges as DM1 oligonucleotide PGN-EDODM1 shows record splicing correction in Phase 2
    PepGen reported that its experimental oligonucleotide PGN-EDODM1 achieved a mean splicing correction of 46.5% at week 13 in a Phase 2 trial for myotonic dystrophy type 1 (DM1). This performance exc…
    BioSpace · 23h agoPositive readoutPositive↗ source
  • Incoming Democratic committee chairs move to probe Trump-era most-favored-nation drug pricing deals
    The column notes that the newly appointed Democratic chairs of key congressional committees are planning to examine the most-favored-nation (MFN) drug pricing agreements that were negotiated during…
    STAT · 1d agoRegulatoryNeutral↗ source
  • U.S. faces possible loss of measles elimination status as WHO panel convenes
    A WHO regional committee will meet for four days to decide if the United States still meets criteria for measles elimination. Current indicators suggest the country may no longer qualify, raising…
    STAT · 1d agoRegulatoryNegative↗ source
  • Federal panel overseeing preventive care receives blanket ethics waivers despite members' pharma and practice conflicts
    Federal officials granted blanket ethics waivers to every member of the U.S. Preventive Services Task Force, allowing them to serve despite clear financial conflicts of interest. Documents show so…
    STAT · 1d agoRegulatoryNegative↗ source
  • Flagship-backed Valo Health merges with Montai Therapeutics to boost AI-driven drug pipeline
    Valo Health and Montai Therapeutics announced they will combine under the Valo brand, creating a larger AI-focused biotech aimed at accelerating early-stage drug discovery. Valo, launched in 2020…
    Fierce Biotech · 1d agoDealPositive↗ source
  • US biotech faces growth slowdown as China’s coordinated investment threatens industry
    During a BioSpace webinar, industry experts warned that uncertainty in U.S. policy is slowing biotech growth while China accelerates its life-science sector with deliberate investment. Strand Ther…
    BioSpace · 1d agoRegulatoryNegative↗ source
  • FDA issues warning letters to two Chinese API makers for refusing record requests
    The U.S. Food and Drug Administration sent warning letters to Chongqing Qiancan Technology and Tianjin Healthcare Medical Technology after both companies declined to provide records the agency requ…
    BioSpace · 22h agoRegulatoryNegative↗ source
  • Capricor trims 10% of workforce as FDA decision on Duchenne cell therapy approaches
    Capricor Therapeutics announced it is cutting about 10% of its staff ahead of an upcoming FDA decision on its Duchenne muscular dystrophy cell therapy, deramiocel. The biotech said it had 231 full…
    BioSpace · 23h agoLayoffsNegative↗ source
  • MDCalc unveils CrossCover to boost clinician confidence in AI chatbot answers while protecting privacy
    MDCalc, a medical reference website, announced a new tool called CrossCover. CrossCover is designed to check clinicians' queries for privacy issues and evaluate AI chatbot responses for accuracy,…
    STAT · 1d agoPositive↗ source
  • Capricor cuts 10% of staff as it readies FDA decision on DMD cell therapy, NextCure trims workforce ahead of merger
    Capricor Therapeutics announced that it has reduced its workforce by about 10% during the third quarter, bringing its employee count down from 231 full‑time staff. The company said it had $198.5 mi…
    Fierce Biotech · 1d agoLayoffsNeutral↗ source
  • Amgen builds Sjögren’s case with detailed phase 3 data ahead of Novartis showdown
    Amgen has shared more data from a phase 3 Sjögren’s disease trial that dazzled analysts, digging into the details that could shape its showdown with Novartis.
    Fierce Biotech · 1d agoDealNeutral↗ source
  • Former ER doctor argues that limiting data input can improve clinical AI tools
    Graham Walker, a former emergency‑room physician and co‑founder of MDCalc, was interviewed for STAT’s AI Prognosis newsletter about his new AI tool. Walker explains that giving AI systems only the…
    STAT · 23h agoNeutral↗ source
  • BioSpace launches dashboard to track performance of U.S. biotech IPOs in 2026
    BioSpace introduced a new IPO dashboard that monitors U.S. biotech companies that went public in 2026. The tool will be refreshed weekly with the latest closing prices and will add any newly liste…
    BioSpace · 1d agoNeutral↗ source
  • Health-care providers sue employers over out-of-network medical bills
    Providers are increasingly filing lawsuits against employers, arguing that the companies are liable for out-of-network medical charges that insurers have not fully paid or have delayed. One recent…
    STAT · 1d agoRegulatoryNeutral↗ source
  • MAHA backs convicted rapist Russell Brand, highlighting toxic culture within movement
    MAHA Action, the super PAC behind the Make America Healthy Again movement, published a lengthy defense of British comedian Russell Brand after he was sentenced to 10.5 years in prison for rape. Br…
    STAT · 21h agoNegative↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 1d agoLayoffsNegative↗ source
  • Rising food costs and aid cuts leave low-income parents unable to risk nutritious meals for picky eaters
    Rising food prices and cuts to food assistance programs are tightening budgets for low-income families, making fruits and vegetables a less affordable option. When a child refuses a healthy item,…
    STAT · 1d agoNegative↗ source
  • Bayer's Sunharbo becomes first FDA-approved factor XIa inhibitor blood thinner
    Bayer's oral anticoagulant Sunharbo, known as asundexian, has received FDA approval, making it the first factor XIa inhibitor cleared for use in the United States. The drug is intended to lower th…
    BioSpace · 2d agoApprovalPositive↗ source
  • BIO chief warns US biotech must act now to stay ahead of China’s new five-year plan
    John F. Crowley, CEO of the Biotechnology Innovation Organization, says China has unveiled a five-year strategy that labels biotechnology a national pillar industry and aims to overtake the United…
    STAT · 2d agoRegulatoryNegative↗ source
  • Beam Therapeutics' base-edited risto-cel shows 12-month pain-crisis freedom in sickle cell trial, paving way for FDA filing
    Beam Therapeutics reported that its base-edited cell therapy, risto-cel, achieved at least 12 consecutive months without severe vaso-occlusive crises in patients with sickle cell disease during a m…
    BioSpace · 1d agoPositive readoutPositive↗ source
  • Beam Therapeutics reports year-long reduction in sickle cell crises in phase 1/2 risto-cel study
    Beam Therapeutics disclosed data from its phase 1/2 trial of risto-cel, a base-edited autologous cell therapy targeting the BCL11A gene in sickle cell disease. The trial enrolled 31 adults and ado…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
  • Ionis shares tumble over $1 billion as Tryngolza sales forecast cut in half
    Ionis Pharmaceuticals saw its market value drop by more than $1 billion after it lowered its sales outlook for Tryngolza, a triglyceride‑lowering therapy. The company now expects $50 million in sa…
    STAT · 2d agoNegative↗ source
  • FDA's new rare-disease framework faces first test with Capricor's Duchenne therapy decision
    The FDA announced a new "fit-for-purpose" rare disease framework that aims to evaluate therapies based on patient need and realistically attainable evidence. The first real test of the approach wi…
    BioSpace · 1d agoRegulatoryNeutral↗ source