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629 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 · 15d 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 · 15d 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 · 15d 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 · 15d ago↗ source
  • Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera Positive Pressure Breathing Devices
    Volara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.
    fda medwatch · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 16d 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 · 16d 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 · 16d ago↗ source
  • Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Delivery Catheter System (DCS)
    The distal tip in certain lots of the Medtronic Harmony Delivery Catheter System (DCS) may detach which can require endovascular retrieval or surgical intervention.
    fda medwatch · 16d 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 · 18d 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 · 18d 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 · 18d 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 · 18d 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 · 18d 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 · 19d 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 · 19d 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 · 19d ago↗ source
  • The data that led Cellular Intelligence to pick up Novo's Parkinson's stem cell therapy
    MONTREAL — After Novo Nordisk closed its cell therapy unit, Cellular Intelligence contracted neurologist and drug developer Nuno Mendonça to conduct due diligence on the Danish pharma’s Parkinson’s…
    Endpoints · 19d ago↗ source
  • Pfizer appoints obesity discovery head; AI startup Xaira makes leadership adjustments
    → Danna Breen has been promoted to head of obesity discovery at Pfizer, according to a LinkedIn post. Breen succeeds Kendra Bence and gets this opportunity after nearly 14 years with ...
    Endpoints · 19d ago↗ source
  • ARPA-H bookmarks $160M for custom gene editing treatments. Is it enough?
    After an infant last year was saved from a deadly disease thanks to a bespoke gene editing therapy that fixed an incredibly rare mutation in his DNA, the US government is hoping ...
    Endpoints · 19d ago↗ source
  • HHS advances plan to pay out Covid-19 vaccine injury claims
    A newly proposed HHS rule would establish a compensation mechanism for people who claim they were injured by Covid-19 vaccines, as a key panel that oversees broader vaccine injury payments remains…
    Endpoints · 19d ago↗ source
  • Roche ends work on tominersen after decade of trials, as well as early-stage Huntington’s asset
    After more than a decade of work and plenty of ups and downs, Roche has dropped its Huntington’s disease drug tominersen. The decision comes after tominersen did no better than placebo in a Phase 2…
    Endpoints · 19d ago↗ source