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1,236 stories matching this filter · ← front page

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  • BIO 2026 in San Diego features executive interviews on biotech trends and opportunities
    The BIO International Convention gathered more than 20,000 life‑science leaders in San Diego, serving as a major forum for biotech discussion. During the event, Fierce conducted a series of video…
    Fierce Biotech · 1mo agoNeutral↗ source
  • FDA issues final guidance for psychedelic drug developers and announces public hearing
    The FDA has completed a set of clinical guidance documents aimed at companies developing psychedelic medicines. The guidance outlines expectations for trial design, safety monitoring, and data col…
    Endpoints · 1mo agoRegulatoryPositive↗ source
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  • Digital health funding jumps to $7.4 billion in first half of 2026
    Digital health startups secured $7.4 billion in venture capital during the first six months of 2026, according to research firm Rock Health. This represents a $1 billion increase compared with the…
    Endpoints · 1mo agoDealPositive↗ source
  • Biopharma M&A Surge Sets Tone for 2026 Earnings Season
    The biopharma sector is entering the second half of 2026 after a year marked by unusually high merger and acquisition activity. Companies have been busy negotiating and closing deals, signaling con…
    Endpoints · 1mo agoDealNeutral↗ source
  • Ohio launches $30M Life Science Training Center to boost biomanufacturing workforce
    Ohio’s JobsOhio agency and the Ohio Life Sciences Association announced a public-private training center backed by up to $30 million. The center is intended to create a statewide pipeline of operat…
    Fierce Biotech · 1mo agoPositive↗ source
  • FDA issues complete response letter rejecting Tris Pharma’s narcolepsy candidate; Agenus halts Phase 3 colorectal cancer trial
    The U.S. Food and Drug Administration sent Tris Pharma a complete response letter for its experimental treatment for narcolepsy, stating that additional data are required before approval can be con…
    Endpoints · 1mo agoCRLNegative↗ source
  • FDA proposes new rule to streamline registration of drug manufacturers' factories
    The FDA announced a proposed rule aimed at changing how factories that produce drugs for the U.S. market are registered with the agency. The change is intended to simplify the registration process…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Cayman court orders Apple Tree Partners to lose control of its venture fund
    A Cayman Islands court ruled that Apple Tree Partners' general partner must give up control of its venture fund. The decision follows a dispute with the fund's main limited partner, and the judge…
    Endpoints · 1mo agoNeutral↗ source
  • Weekly roundup highlights Biohaven’s challenge to Eli Lilly and industry competition with China
    The latest Endpoints Weekly issue focuses on a series of recent deals across the biotech sector, offering readers a snapshot of market activity. Among the items highlighted is Biohaven’s strategic…
    Endpoints · 1mo agoDealNeutral↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo ago↗ source
  • UK price watchdog recommends against Amgen's Lumakras in lung cancer
    The UK’s drug pricing watchdog said government reimbursement of Amgen’s lung cancer drug Lumakras should be cut off for new patients. In draft guidance released on Thursday, the National Institute…
    Endpoints · 1mo ago↗ source
  • FDA criticizes Lundbeck for webpages on migraine treatment Vyepti
    The FDA has chastised Lundbeck Seattle Biopharmaceuticals for two promotional webpages that made allegedly inflated claims regarding the efficacy of its migraine drug. In an untitled letter sent la…
    Endpoints · 1mo ago↗ source
  • FDA quietly stops releasing CRLs
    The FDA has paused its public release of pharma rejection letters as the agency seeks to avoid litigation around releasing the often sensitive information. The pause follows a law firm in April
    Endpoints · 1mo ago↗ source
  • The biggest health tech stories of 2026 — so far
    We’re more than halfway through 2026, and it’s been an eventful year. Here are the five biggest developments we noticed in the first six months. Major AI companies are coming for healthcare.
    Endpoints · 1mo ago↗ source