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370 stories matching this filter · ← front page

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  • Hansoh reports Phase 3 success for GSK‑partnered ADC in SCLC as FDA clears Sanofi on‑body injector
    Hansoh announced that its Phase 3 trial of the antibody‑drug conjugate Ris‑Rez met the primary endpoint in patients with small cell lung cancer. The study was conducted in partnership with GSK and…
    Endpoints · 1mo agoRegulatoryPositive↗ 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 · 1mo agoRegulatoryNeutral↗ source
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  • UK regulator advises stopping reimbursement for Amgen's lung cancer drug Lumakras for new patients
    The National Institute for Health and Care Excellence (NICE) in the United Kingdom released draft guidance recommending that government reimbursement for Amgen’s lung cancer therapy Lumakras be dis…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • AstraZeneca and GSK strike new China partnerships with Sino Biopharm
    Sino Biopharm announced two separate agreements with the United Kingdom's largest drugmakers, AstraZeneca and GSK, to deepen their presence in the Chinese market. AstraZeneca will license rights t…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Lung transplants boost survival for select stage 4 lung cancer patients, study finds
    Northwestern Medicine surgeons and oncologists performed double lung transplants on a small group of stage 4 lung cancer patients whose disease was confined to the lungs. The JAMA study compared 1…
    STAT · 2mo agoPositive readoutPositive↗ source
  • FDA approves Vera Therapeutics' Trutakna for IgA nephropathy, pricing set at $425,000 per year
    The U.S. Food and Drug Administration has granted approval to Trutakna, a new therapy from Vera Therapeutics, for the treatment of IgA nephropathy. IgA nephropathy is a kidney disorder where immun…
    STAT · 2mo agoApprovalPositive↗ source
  • Sino Biopharm signs separate respiratory partnership deals with AstraZeneca and GSK
    Sino Biopharm announced it has entered into two distinct agreements with UK-based pharmaceutical companies focused on respiratory medicines. One agreement involves licensing its investigational PD…
    Endpoints · 2mo agoDealPositive↗ source
  • FDA grants accelerated approval to Vera Therapeutics' Trutakna for IgA nephropathy
    The FDA has granted accelerated approval to Trutakna (formerly known as atacicept) from Vera Therapeutics for adult patients with IgA nephropathy, a chronic kidney disease that can progress to rena…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • Vertex to buy Crinetics for $10 billion, adding acromegaly drug Palsonify
    Vertex Pharmaceuticals announced a $10 billion acquisition of Crinetics Pharmaceuticals, marking the largest deal in Vertex’s history. The purchase gives Vertex control of Crinetics’ marketed ther…
    STAT · 2mo agoDealPositive↗ source
  • Novartis to buy Myricx Bio for up to $1.5 billion, adding two novel ADCs to its oncology portfolio
    Novartis announced it will acquire Myricx Bio, a UK‑based biotech that develops antibody drug conjugates (ADCs), in a move to broaden its oncology pipeline. The transaction is valued at up to $1.5…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Novartis to buy Myricx Bio for $1.1 billion as Medicare proposes steep 340B cuts and other biotech policy updates
    Novartis announced it will acquire UK‑based Myricx Bio for an upfront $1.1 billion, adding an antibody‑drug conjugate platform aimed at solid‑tumor cancers. The agreement also includes potential mi…
    STAT · 2mo agoDealNeutral↗ source
  • Anthropic CEO says AI’s biotech breakthrough may still be a decade away despite current hype
    In a recent on‑stage conversation, Matthew Herper interviewed Dario Amodei, the CEO and co‑founder of Anthropic, about the role of artificial intelligence in biotechnology. The discussion took plac…
    STAT · 2mo agoNeutral↗ source
  • GOP lawmakers urge FDA under Trump to enforce diversity in clinical trial enrollment
    Republican members of Congress have asked the Food and Drug Administration, now led by President Trump, to adopt policies that require clinical trials to enroll participants who reflect the diversi…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Roche’s divarasib shows survival benefit over Amgen and BMS drugs in KRAS G12C lung cancer trial
    Roche reported that its experimental KRAS G12C inhibitor divarasib extended overall survival and progression‑free survival in a Phase 3 head‑to‑head study against Amgen’s Lumakra and Bristol Myers…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Roche's KRAS G12C inhibitor divarasib outperforms Amgen and Bristol Myers Squibb drugs in Phase 3 head-to-head trial
    Roche announced that its KRAS G12C inhibitor divarasib showed superiority over existing marketed therapies from Amgen and Bristol Myers Squibb in a Phase 3 head-to-head trial in lung cancer. The t…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Celea Therapeutics raises $180 million to advance next-generation IPF drug deupirfenidone
    Celea Therapeutics, a PureTech Health spinout, announced a $180 million venture round to fund development of its next-generation idiopathic pulmonary fibrosis (IPF) therapy, deupirfenidone. The ro…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Roche announces drug that sets new benchmark for KRAS‑driven lung cancer
    Roche has announced a new therapy that it says establishes a new standard of care for patients with KRAS‑driven lung cancer. The announcement was featured in a STAT+ newsletter, underscoring the p…
    STAT · 2mo agoPositive readoutPositive↗ source
  • Celea Therapeutics secures $180M financing to advance IPF pipeline
    Celea Therapeutics, an idiopathic pulmonary fibrosis (IPF) biotech, announced it has raised $180 million from a group of new investors. The funding is intended to help the company follow the devel…
    Endpoints · 2mo agoDealNeutral↗ source
  • CDC leadership accused of stifling vaccine effectiveness studies and reshaping advisory committee role
    Ben Lopman, a professor of epidemiology and global health at Emory University, wrote an opinion piece warning that CDC leadership is trying to manufacture a scientific debate about vaccines where n…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Hamilton Medical issues updated use instructions for certain breathing circuit sets after serious recall
    Hamilton Medical has sent a letter to customers on May 18, 2026, advising updated use instructions for specific coaxial breathing circuit sets used with its HAMILTON-C1, HAMILTON T-1 and HAMILTON-M…
    fda medwatch · 2mo agoCRLNegative↗ source
  • Loss of Colorado Rep. Diana DeGette removes a knowledgeable voice for biopharma in Congress
    Colorado Democratic Rep. Diana DeGette was defeated in her primary, ending her service in the U.S. House of Representatives. DeGette was widely recognized for her deep understanding of biopharma p…
    STAT · 2mo agoNegative↗ source
  • Ebola and Marburg outbreaks highlight need for pathogen-agnostic diagnostics
    The authors describe a current Bundibugyo Ebola outbreak affecting the Democratic Republic of Congo and Uganda, which has resulted in more than 1,300 confirmed cases and over 375 deaths. While the…
    STAT · 2mo agoNegative↗ source
  • FDA permits Zyn nicotine pouches to be marketed as safer than cigarettes
    The U.S. Food and Drug Administration announced that Zyn's nicotine pouches can be advertised as a safer alternative to traditional cigarettes. The decision reflects the agency's view that the pouc…
    STAT · 2mo agoRegulatoryPositive↗ source
  • Biotech sector eyes key clinical trial readouts in H2 2026 across cancer, Alzheimer’s and autoimmune diseases
    The first half of 2026 saw a surge in biotech activity, with record‑high deal flow, several large IPOs and a regulatory environment that appears to be stabilising after a period of uncertainty. An…
    BioPharma Dive · 2mo agoNeutral↗ source
  • FDA picks seven firms for PreCheck pilot to boost U.S. drug manufacturing
    The FDA announced on June 29, 2026 that seven companies have been chosen for its PreCheck Pilot Program, an initiative aimed at strengthening U.S. drug manufacturing and supply chain resilience. T…
    fda press · 2mo agoRegulatoryPositive↗ source