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  • Phase 3 trial shows pre- and post-surgery hormone therapy improves outcomes for high-risk prostate cancer
    A phase 3 study called PROTEUS evaluated high‑risk, early‑stage prostate cancer patients who were scheduled for surgery. The trial compared a regimen that gave two hormone therapies before and afte…
    STAT · 3mo agoPositive readoutPositive↗ source
  • RevMed earns standing ovation at ASCO for pancreatic cancer data while Akeso faces caution
    At the American Society of Clinical Oncology meeting, RevMed captured audience attention with data on its pancreatic cancer therapy, earning a rare standing ovation. In contrast, presentations fro…
    STAT · 3mo agoNeutral↗ source
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  • Ultra-low dose nivolumab shows survival benefit for head and neck cancer patients in India
    Researchers presented data at the American Society of Clinical Oncology meeting showing that an ultra‑low dose of the PD‑1 inhibitor nivolumab, given with chemotherapy, extended survival for patien…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Ivonescimab cuts death risk by one-third in Chinese lung cancer trial, adds four-month survival
    A trial in China evaluated ivonescimab combined with chemotherapy in patients newly diagnosed with advanced non-small cell lung cancer. The study was presented at the American Society of Clinical O…
    BioPharma Dive · 3mo agoPositive readoutNeutral↗ source
  • Personalized vaccines show promise in extending survival for some brain cancer patients, Dana-Farber study finds
    Personalized cancer vaccines are being investigated as a way to make aggressive brain tumors more responsive to immunotherapy, according to new research from the Dana-Farber Cancer Institute. The…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Revolution Medicines begins shipping experimental pancreatic cancer drug daraxonrasib under FDA early access program
    Revolution Medicines announced that it has started sending its experimental pancreatic cancer therapy, daraxonrasib, to doctors and patients through an FDA‑authorized early access program. The comp…
    STAT · 3mo agoRegulatoryPositive↗ source
  • BioNTech and Pfizer present bispecific cancer data at ASCO, FDA chief notes optimism
    At the American Society of Clinical Oncology meeting, BioNTech and Pfizer highlighted early results from bispecific antibody programs aimed at lung cancer. The companies described the data as promi…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Former FDA oncology chief says political turmoil opens chance to reshape agency amid rising Chinese competition
    Rick Pazdur, who led oncology reviews at the FDA, told a STAT audience at the American Society of Clinical Oncology meeting that recent political appointments have caused significant disruption at…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Experts say Grail’s multi-cancer blood test not yet ready for routine screening
    At the ASCO 2026 meeting in Chicago, Grail presented its multi-cancer early detection blood test, which the company markets as a tool to identify several cancers at an early stage. Independent exp…
    Endpoints · 3mo agoNegative↗ source
  • Bristol Myers reports Phase 3 data showing mezigdomide extends survival in relapsed multiple myeloma
    Bristol Myers Squibb presented Phase 3 results for its experimental multiple myeloma drug mezigdomide at the American Society of Clinical Oncology meeting. The study evaluated mezigdomide combined…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Pfizer partners with China's Innovent Biologics on $10 billion cancer drug collaboration
    Pfizer announced a major partnership with Chinese biotech Innovent Biologics, valued at over $10 billion, to develop cancer therapies. The agreement covers up to 12 antibody-based candidates, incl…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Pfizer partners with China's Innovent Biologics on $10.5 billion deal for 12 early-stage cancer programs
    Pfizer announced a collaboration with Innovent Biologics of China to develop a suite of cancer therapies. The agreement covers up to 12 early-stage antibody‑drug conjugates and multi‑specific anti…
    Endpoints · 3mo agoDealPositive↗ source
  • Merck touts promising ADC sacituzumab tirumotecan as potential cornerstone therapy at ASCO
    Merck highlighted a new antibody-drug conjugate, sacituzumab tirumotecan (sac-TMT), licensed from Chinese biotech Kelun-Biotech, at the ASCO meeting. The company said early clinical data have give…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Positive data from Bristol Myers in multiple myeloma and Pfizer in lung cancer unveiled at ASCO
    At the American Society of Clinical Oncology (ASCO) meeting, Bristol Myers Squibb presented early-stage results that showed a favorable response in a multiple myeloma trial. The data suggest the in…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Replimune to file third FDA application for RP1 cancer therapy after productive talks
    Replimune announced it will submit a third marketing application for its experimental cancer therapy RP1, following what the company described as productive discussions with the Food and Drug Admin…
    BioPharma Dive · 3mo agoApprovalPositive↗ source
  • AstraZeneca explores options after anselamimab fails Phase 3, while Imfinzi and Tremfya receive label expansions
    AstraZeneca announced that its experimental monoclonal antibody anselamimab failed to meet the primary endpoint in two Phase 3 trials for a specific patient group. The company said it will explore…
    Endpoints · 3mo agoNegative readoutNeutral↗ source
  • Allogene CEO David Chang to step down as Agios drug misses mid-stage trial results
    Allogene announced that its chief executive, co‑founder David Chang, will leave the role after an eight‑year tenure. Chang, who previously worked at Kite Pharma, will remain on the company’s board…
    BioPharma Dive · 3mo agoNegative readoutNeutral↗ source
  • FDA releases draft guidance to trim animal testing in cancer drug development
    The FDA's Oncology Center of Excellence announced a draft guidance aimed at reducing unnecessary animal studies in the nonclinical safety assessment of certain oncology drugs. The guidance suggest…
    fda press · 3mo agoRegulatoryPositive↗ source
  • Replimune seeks third FDA approval attempt, Pfizer signs China deal, panel backs updated Covid vaccine
    Replimune is pursuing a third attempt to secure FDA approval for its investigational therapy, after two prior submissions did not succeed. Pfizer has entered into a new agreement to expand its pre…
    STAT · 3mo agoNeutral↗ source
  • Allogene announces CEO David Chang will step down
    Allogene Therapeutics disclosed that its chief executive, David Chang, will be leaving the company. The firm indicated that a succession plan is in place, though it did not provide a specific timel…
    STAT · 3mo agoNeutral↗ source
  • Replimune to resubmit melanoma therapy RP1 to FDA after two prior rejections
    Replimune announced on Friday that it will again submit its advanced melanoma candidate, RP1, to the U.S. Food and Drug Administration for review. The company says the filing follows new discussion…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Kenyan court halts U.S. plan for Ebola quarantine facility for Americans
    A Nairobi High Court on Friday ordered a stop to a U.S. proposal to build a quarantine center in Kenya for Americans who might have been exposed to a rare Ebola strain circulating in northeastern C…
    STAT · 3mo agoRegulatoryNegative↗ source
  • GC Therapeutics appoints former BlueRock executive Stefan Irion as chief scientific officer
    GC Therapeutics announced that Stefan Irion has joined the company as its new chief scientific officer. Irion previously served in the same capacity at BlueRock Therapeutics. Irion brings experien…
    STAT · 3mo agoNeutral↗ source
  • GSK and Ionis report functional cure in 20% of hepatitis B patients with bepirovirsen in early trials
    GSK and Ionis disclosed results from two clinical studies of their RNA‑based injection, bepirovirsen, aimed at achieving a functional cure for chronic hepatitis B. In both trials about one‑fifth o…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • AbbVie receives FDA approval for ultra-rare blood cancer ADC acquired from ImmunoGen
    AbbVie announced that the U.S. Food and Drug Administration has granted approval for an antibody-drug conjugate targeting an ultra-rare, aggressive form of blood cancer. The therapy was obtained t…
    Endpoints · 3mo agoApprovalPositive↗ source