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1,087 stories matching this filter · ← front page

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  • Genetic medicine startup Lyora launches with programs from Editas, Biogen
    Lyora Therapeutics will try to revive several early-stage genetic eye disease programs previously held by Editas Medicine and Biogen. The biotech was co-founded by Luk Vandenberghe and Eric Pierce,…
    Endpoints · 16d ago↗ source
  • AstraZeneca to take rights to Dizal's lung cancer pill Zegfrovy
    AstraZeneca is set to pay Dizal Pharmaceutical, which it part-owns, $600 million upfront for worldwide development and sales rights to the lung cancer drug Zegfrovy. The UK pharma said Tuesday that…
    Endpoints · 16d ago↗ source
  • In latest deal, Innovent seeds Spero's future beyond GSK-owned antibiotic
    After partnering with four of the largest pharmaceutical companies over the past 18 months, Innovent Biologics is turning to a smaller partner for its next bet. An autoimmune drug candidate from th…
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Endpoints · 16d ago
↗ source
  • Former Akero team announces new I&I company, Avere, with China drug
    Everything around China biotech really does seem to be speeding up. On Tuesday, the former executive team behind Akero Therapeutics unveiled a new company, a pipeline drug from China and a reverse…
    Endpoints · 16d ago↗ source
  • Experts: Industry to benefit from focused follow-ups, major deficiency letters in MDUFA VI
    Industry experts say the draft commitment letter for the next Medical Device User Fee Amendments (MDUFA VI) program negotiated by the US Food and Drug Administration (FDA) and the medtech industry…
    raps · 16d ago↗ source
  • Cayman court says Apple Tree general partner should lose control of venture fund
    The embattled venture firm Apple Tree Partners has suffered a loss in a Cayman Islands court case against its main limited partner. A judge in the Grand Court of the Cayman Islands ruled on Friday ...
    Endpoints · 17d ago↗ source
  • FDA finalizes guidance on psychedelics, plans broader hearing
    The FDA has finalized clinical guidance for psychedelic drug developers and has scheduled a public hearing on future therapeutic use, adding regulatory momentum to a class on the precipice of appro…
    Endpoints · 17d ago↗ source
  • Freenome colorectal cancer test data improve on earlier results
    The new study results could make Abbott, which has an agreement with Freenome to market the blood-based test, the dominant player in colorectal cancer screening, Evercore ISI analysts said.
    BioPharma Dive · 17d ago↗ source
  • FDA proposes rule to simplify drugmakers' factory registrations
    The FDA is proposing a rule to change how factories are registered with the agency if they are making products for the US market, as part of a continuing effort to try to speed up ...
    Endpoints · 17d ago↗ source
  • Q32 bounces back to claim study success for alopecia drug
    Nearly two years after clinical setbacks cratered Q32’s stock price, new results showed hair growth improvements that surpassed investors’ expectations.
    BioPharma Dive · 17d ago↗ source
  • Health tech funding rises to $7.4B in the first half of 2026
    Digital health startups raised $7.4 billion in venture funding during the first half of 2026, up $1 billion from the first half of 2025, according to research and venture firm Rock Health. Megaroun…
    Endpoints · 17d ago↗ source
  • Agenus surges on study pivot; Apnimed lines up an IPO
    Agenus is financially abandoning an ongoing study in late-line colorectal cancer. Elsewhere, an ebola vaccine began human testing and an important Bristol Myers medicine got an FDA decision date.
    BioPharma Dive · 17d ago↗ source
  • Busy M&A activity sets tone as biopharma earnings season kicks off
    With the first half of 2026 officially in the books and another earnings season about to begin, a key question hangs over the biopharma industry: Will the good times continue? The answer to that ma…
    Endpoints · 17d ago↗ source
  • Tris Pharma's CRL for narcolepsy drug; Agenus abandons Phase 3 CRC trial
    Plus, news about Insilico, Ipsen, Q32 Bio, GSK’s Jemperli, Drug Farm and Padcev. ❌ FDA rejects Tris Pharma’s narcolepsy drug: Its rejection letter said that “additional information will be necessar…
    Endpoints · 17d ago↗ source
  • Biotech startup funding gap widens despite rebound in VC investment
    Though funding totals represented the highest first-half sum since the start of 2022, industry watchers are concerned that small startups are being left behind.
    BioPharma Dive · 17d ago↗ source
  • Deals, deals, deals; Biohaven takes on Eli Lilly; and more
    Welcome back to Endpoints Weekly! Don’t miss Ryan Cross’ deep dive into the paranoia caused by competition with China. Ryan writes that US biotech companies are holding their cards close to the ...
    Endpoints · 19d ago↗ source
  • Apnimed files for IPO as FDA reviews its sleep apnea drug
    Apnimed is finally going forward with an IPO attempt after years of flirting with the milestone. The Cambridge, MA-based biotech revealed its Nasdaq plans on Friday night, following a strong six ...
    Endpoints · 19d ago↗ source
  • FDA returns to releasing pharma rejection letters with 14 new CRLs
    The FDA on Friday posted 14 new rejection letters to pharma companies online, days after HHS confirmed to Endpoints News that the agency had paused new CRL releases because of a pharma-backed ...
    Endpoints · 20d ago↗ source
  • FDA rejects Hengrui-Elevar liver cancer drug combo for third time
    For the third time in about two years, the FDA has cited manufacturing deficiencies in rejecting a drug combination from Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics intended to treat th…
    Endpoints · 20d ago↗ source
  • CDER adds 100+ new employees in a quarter for first time since late 2024
    The FDA's drug center hired more new employees than it lost in a quarter for the first time since the Trump administration gutted the agency's ranks in April 2025. The FDA's
    Endpoints · 20d ago↗ source
  • US biotechs turn secretive as they fear competition from rising Chinese industry
    Janine Sengstack believes she may have found the next big breakthrough in diabetes and obesity. Her company, Junevity, has searched through hundreds of genes to discover ones that, when repressed,…
    Endpoints · 20d ago↗ source
  • GSK, Hansoh ADC extends survival in lung cancer study
    GSK claimed the result was a first for an ADC aimed at the “B7-H3” protein, an increasingly popular target of late among cancer drugmakers.
    BioPharma Dive · 20d ago↗ source
  • German lawmakers pass cost-saving bill that drugmakers say will drive them out
    Germany’s federal parliament has voted to pass a bill designed to cut domestic healthcare spending that could negatively impact drugmakers, drawing sharp criticism from the country’s main pharmaceu…
    Endpoints · 20d ago↗ source
  • Hansoh meets Phase 3 SCLC goal; FDA approves Sanofi on-body injector
    Plus, news about Huntington's, Fate Therapeutics and Bausch + Lomb. 🇨🇳 Hansoh touts Phase 3 success for GSK-partnered ADC: The program, called risvutatug rezetecan or Ris-Rez, met its primary end…
    Endpoints · 20d ago↗ source
  • FDA Proposes Rule to Modernize Drug Manufacturing Registration
    The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a…
    fda press · 20d ago↗ source