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1,038 stories matching this filter · ← front page

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  • 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 · 18d 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 · 18d 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.
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Nephrology239
BioPharma Dive · 18d 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 · 18d 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 · 18d 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 · 18d 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 · 20d 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 · 21d 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 · 21d 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 · 21d 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 · 21d 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 · 21d 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 · 21d 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 · 21d 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 · 21d 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 · 21d ago↗ source
  • ARPA-H puts $160M into bespoke drug therapies; Biohaven switches up scientific leadership
    The ARPA-H program could provide researchers with a roadmap to develop personalized gene editing drugs. Elsewhere, a Botox rival succeeded against migraines and two deals were struck.
    BioPharma Dive · 21d 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 · 21d 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 · 21d ago↗ source
  • Roche scraps two Ionis-partnered Huntington’s drugs
    The Swiss pharmaceutical giant told patient groups tominersen didn't delay disease progression in one trial, while a study of a second drug was scrapped because of a safety signal in animal testing.
    BioPharma Dive · 22d 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 · 22d 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 · 22d 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 · 22d 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 · 22d 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 · 22d ago↗ source