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  • Roche reports narrow failure of breast cancer pill in Phase 3 trial at ASCO
    Roche updated investors and the oncology community that its experimental breast cancer oral therapy did not meet its primary endpoint in a pivotal Phase 3 study. The data, presented at the America…
    Endpoints · 3mo agoNegative readoutNegative↗ source
  • Fulcrum Therapeutics considers sale after FDA blocks sickle cell drug development
    Fulcrum Therapeutics announced it is undertaking a strategic review that could lead to a sale after its lead sickle cell candidate, pociredir, was effectively blocked by the FDA. The agency cited…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
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  • AbiVax shares plunge as safety concerns shadow strong ulcerative colitis trial results
    AbiVax reported Phase 3 data for its experimental therapy obefazimod in patients with moderately to severely active ulcerative colitis. Two dose levels achieved placebo‑adjusted clinical remission…
    BioPharma Dive · 3mo agoNegative readoutNegative↗ source
  • ASCO 2026 Highlights Bispecific Antibodies, ADCs and New Advances in RAS-Targeted and Prostate Cancer Therapies
    The meeting featured a lively comparison of bispecific antibodies and antibody-drug conjugates as leading modalities in oncology. Researchers presented data suggesting that targeting mutant RAS pr…
    BioPharma Dive · 3mo agoPositive↗ source
  • Allen Institute launches multi-hundred-million-dollar effort to turn brain atlas data into neurodegenerative drug candidates
    The Allen Institute, a Seattle nonprofit known for basic brain research, announced a major new effort to move its brain‑atlas knowledge toward drug development. The program will invest several hun…
    Endpoints · 3mo agoPositive↗ source
  • Celcuity's gedatolisib trial cuts death risk but misses investor expectations
    Celcuity reported data from its Phase 3 VIKTORIA-1 trial evaluating gedatolisib in HR‑positive, HER2‑negative breast cancer with PIK3CA mutations. The trial enrolled 350 patients who had progresse…
    BioPharma Dive · 3mo agoNegative readoutNegative↗ source
  • FDA issues draft guidance outlining data flexibilities for cell and gene therapy developers
    The FDA released a draft guidance from its Center for Biologics Evaluation and Research (CBER) that clarifies how developers of cell and gene therapies can use existing data and prior knowledge in…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • NewLimit secures $435M funding, valuation tops $3B, aims for human trials in 2027
    NewLimit, a Bay Area anti-aging biotech, announced a financing round that raised $435 million, valuing the company at more than $3 billion. The round is among the largest private biotech financing…
    Endpoints · 3mo agoDealPositive↗ source
  • Eli Lilly gives 340B hospitals a week to share data or lose drug discounts
    Eli Lilly has told hospitals and medical groups that participate in the 340B drug discount program that they must submit claims data for all Lilly medications by the coming Monday, or they will be…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • Longevity startup NewLimit secures $435 million Series C as it prepares first liver drug trial
    NewLimit, a longevity‑focused biotech founded in 2021, announced a Series C financing that brought in $435 million, pushing its valuation to about $3.1 billion. The round was led by Founders Fund…
    STAT · 3mo agoDealPositive↗ source
  • Radiopharmaceutical shows promise after Pluvicto; Vera Therapeutics gains FDA agreement to speed IgA nephropathy data analysis
    A new radiopharmaceutical is generating interest for use after patients have completed Pluvicto therapy, suggesting a potential follow‑on treatment option. Abivax reported encouraging results from…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Contraline secures $92.5M Series B to fund Phase 3 trial of male contraceptive gel
    Contraline, a startup developing a male contraceptive, announced it has closed a Series B financing round worth $92.5 million. The capital will be used to advance its candidate, referred to as NES…
    Endpoints · 3mo agoDealPositive↗ source
  • Travere Therapeutics pays $112 million upfront to China’s Everest Medicines to expand rare kidney disease pipeline
    Travere Therapeutics, a San Diego‑based biotech, announced a partnership with China‑based Everest Medicines to strengthen its rare kidney disease portfolio beyond its approved drug Filspari. Under…
    Endpoints · 3mo agoDealPositive↗ source
  • Legend Biotech reports first in vivo CAR-T data from Chinese lymphoma trial
    Legend Biotech has released its first in vivo CAR-T cell therapy data, marking the next step after its CAR-T product Carvykti. The data come from an investigator-initiated trial in China that enro…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Eli Lilly warns 340B hospitals to submit claims data within five days or lose price discounts
    Eli Lilly has given roughly 50 hospitals that participate in the federal 340B drug discount program a five‑day deadline to provide comprehensive claims data. The company says that if the data are n…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Trump administration releases Medicaid work-requirement rules, prompting state compliance challenges
    The Morning Rounds newsletter highlighted several health‑policy developments, notably new Medicaid work‑requirement rules and fast‑tracked funding for experimental Ebola vaccines. The Trump admini…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Celcuity reports combo regimen with gedatolisib doubles progression‑free survival odds in late‑stage breast cancer
    Celcuity announced at ASCO 2026 that its experimental drug gedatolisib, used in a combination regimen, showed a significant improvement in a late‑stage breast cancer trial. The data revealed that…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Michigan lawmakers introduce bipartisan bill to curb China-U.S. biotech partnerships
    A bipartisan group of Michigan legislators has unveiled a new bill aimed at limiting cross-border transactions between Chinese and American biotechnology firms. The proposal, introduced by Rep. Jo…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Abivax’s ulcerative colitis Phase 3 trial shows promising efficacy but cancer cases raise safety concerns
    Abivax announced that its Phase 3 maintenance trial in ulcerative colitis produced results it called “landmark,” showing the drug’s ability to keep patients in remission. The company emphasized th…
    Endpoints · 3mo agoNegative readoutNegative↗ source
  • US-made packaging equipment offers faster lead times and regulatory alignment for pharma manufacturers
    As pharma firms upgrade their packaging lines, the source of the equipment is becoming a strategic factor rather than a simple purchasing decision. Domestic production shortens lead times and redu…
    BioPharma Dive · 3mo agoPositive↗ source
  • States tighten rules on corporate telehealth, targeting business structures behind direct-to-consumer care
    Telehealth has grown into a multibillion‑dollar industry, with brands like Hims & Hers and Teladoc becoming widely recognized. Despite their visibility, many patients are unaware that corporate te…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Praxis Precision Medicines reports late-stage failure of seizure drug and pauses second trial
    Praxis Precision Medicines had enjoyed a period of momentum, reporting two notable clinical successes in the past eight months. The company’s pipeline had been viewed positively by investors and an…
    Endpoints · 3mo agoNegative readoutNegative↗ source
  • Eli Lilly gives hospitals five days to meet new 340B claims data policy or lose discounts
    Eli Lilly has told a group of hospitals they must adhere to a new claims data policy within five days or their participation in the 340B drug discount program will be terminated. The policy requir…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • ASCO 2026 hints at future role for VEGF-targeted cancer drugs as complement to immunotherapy
    At the recent ASCO meeting, experts discussed the outlook for VEGF-targeted therapies in oncology. Earlier hopes that this new class could match the blockbuster success of pembrolizumab (Keytruda)…
    Endpoints · 3mo agoNeutral↗ source
  • Fulcrum Therapeutics abandons its only sickle cell drug after FDA cites concerns linked to withdrawn cancer therapy
    Fulcrum Therapeutics announced it is ending development of its sole clinical‑stage sickle cell medicine. The move follows feedback from the U.S. Food and Drug Administration that referenced a rece…
    Endpoints · 3mo agoRegulatoryNegative↗ source