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538 stories matching this filter · ← front page

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  • Roche partners with China's Simcere Zaiming on $1.5 billion T-cell engager for B-cell diseases
    Roche announced a licensing agreement with Simcere Zaiming, a subsidiary of China's Simcere Pharmaceutical Group, to develop a trispecific T-cell engager called SIM0660. The deal includes an upfro…
    BioSpace · 12d agoDealPositive↗ source
  • GSK to start Phase 3 trial of mRNA flu vaccine after strong mid-stage results
    GSK announced it will begin a Phase 3 trial of its mRNA-based influenza vaccine, with enrollment slated to start in September. In a Phase 2 study of 971 adults, the investigational vaccine, which…
    BioSpace · 12d agoPositive readoutPositive↗ source
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fda recalls71
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  • Nine midsize biopharma firms join Trump MFN drug pricing program, covering 89% of branded market
    Nine midsize biopharma companies have agreed to voluntarily participate in the Trump administration's Most Favored Nation drug pricing program, adding to the 17 large pharmaceutical firms that prev…
    BioSpace · 12d agoRegulatoryPositive↗ source
  • Arsenal Biosciences cuts 99 jobs as it pivots to in vivo CAR-T therapy
    Arsenal Biosciences announced another round of layoffs, eliminating 99 positions, which represents the majority of its workforce after a prior 50% reduction last year. The cuts are part of a strat…
    BioSpace · 12d agoLayoffsNegative↗ source
  • Biomarin nabs big royalties in achondroplasia patent settlement with Ascendis
    Biomarin has granted Ascendis a non-exclusive, worldwide license to use navepegritide, the active ingredient in the latter company’s recently approved achondroplasia drug Yuviwel, in exchange for 1…
    BioSpace · 13d agoApprovalPositive↗ source
  • Takeda and Protagonist Therapeutics receive FDA approval for rusfertide (Mimrylo) to treat polycythemia vera
    The FDA approved rusfertide, to be sold as Mimrylo, for the treatment of polycythemia vera, a rare blood cancer, marking a key win for Takeda and its partner Protagonist Therapeutics. The decision…
    BioSpace · 13d agoApprovalPositive↗ source
  • US biotech edge erodes as China overtakes in trials and research, raising security concerns
    The United States is losing its lead in biotech as China now conducts more clinical trials and publishes more natural‑science papers. China passed the U.S. six years ago in trial numbers and soon…
    BioSpace · 13d agoNegative↗ source
  • Eli Lilly to acquire Merida Biosciences in up to $2.9 billion deal for precision antibody-degrading therapies
    Eli Lilly announced it will purchase Massachusetts‑based Merida Biosciences, adding a platform that can selectively degrade disease‑causing antibodies. The transaction could total up to $2.875 bil…
    BioSpace · 13d agoDealPositive↗ source
  • Arrowhead’s plozasiran shows favorable safety in severe hypertriglyceridemia late-stage trials
    Arrowhead presented late-stage data for its RNA interference therapy plozasiran, marketed as Redemplo, in severe hypertriglyceridemia at the European Society of Cardiology 2026 meeting in Munich.…
    BioSpace · 13d agoPositive readoutNeutral↗ source
  • BMS leverages Celgene merger to revive neuroscience pipeline amid delayed readouts
    Bristol Myers Squibb, long recognized for its oncology work, is re‑investing in neurological and psychiatric disease programs, a move rooted in assets gained from its 2019 $74 billion Celgene merge…
    BioSpace · 13d agoNeutral↗ source
  • FDA approves Mimrylo, first hepcidin-mimicking drug for polycythemia vera
    The U.S. Food and Drug Administration announced approval of Mimrylo (rusfertide) for adult patients with polycythemia vera, a rare blood disorder that causes excess red blood cells. The drug mimic…
    fda press · 15d agoApprovalPositive↗ source
  • Eli Lilly's Mounjaro gets FDA approval to cut heart attack, stroke risk in type 2 diabetes
    The U.S. Food and Drug Administration has approved Eli Lilly's Mounjaro for reducing the risk of heart attack, stroke, or cardiovascular death in adults with type 2 diabetes who are at high risk fo…
    BioSpace · 16d agoApprovalPositive↗ source
  • Phase 3 trial shows Wainua fails to improve outcomes in ATTR-CM, hazard ratio 1.14
    AstraZeneca and Ionis Pharmaceuticals presented detailed results from the Phase 3 trial of their antisense oligonucleotide Wainua (eplontersen) in patients with transthyretin-mediated amyloid cardi…
    BioSpace · 16d agoNegative readoutNegative↗ source
  • Priovant's Lisraya receives first FDA approval as oral therapy for dermatomyositis
    The U.S. Food and Drug Administration has cleared Priovant Therapeutics' daily TYK2/JAK1 inhibitor tablet, marketed under the name Lisraya, for the treatment of dermatomyositis in adults. Lisraya…
    BioSpace · 16d agoApprovalPositive↗ source
  • BioNTech stops Phase 2 colorectal cancer mRNA vaccine trial after futility findings
    BioNTech announced that it is ending its Phase 2 study of a personalized mRNA vaccine for resected colorectal cancer after the trial failed to show the needed benefit. The news sent the company’s s…
    BioSpace · 16d agoNegative readoutNegative↗ source
  • BioXcel files for Chapter 11 bankruptcy, selling assets to Teva for up to $125 M
    BioXcel Therapeutics announced it has filed for Chapter 11 bankruptcy and plans to sell all of its assets. Teva Pharmaceuticals will serve as the stalking horse bidder, proposing an upfront paymen…
    BioSpace · 16d agoDealNegative↗ source
  • AstraZeneca and Amgen’s Tezspire eyes Dupixent’s EoE stronghold after late-stage trial win
    Analysts note that AstraZeneca and Amgen have secured a late‑stage trial win for Tezspire, positioning the drug as a possible challenger to Dupixent in eosinophilic esophagitis (EoE). Dupixent re…
    BioSpace · 16d agoPositive readoutPositive↗ source
  • Multispecific antibodies push CDMOs to redesign development platforms
    Manufacturers are moving beyond traditional monoclonal-antibody platforms as multispecific therapeutics gain traction. The new design model relies on molecular engineering, advanced analytics, and…
    BioSpace · 16d agoNeutral↗ source
  • CAR T therapy moves from cancer to autoimmune disease, leveraging oncology safety lessons
    Cell therapy that transformed treatment of blood cancers is now being tested for autoimmune disorders, according to a recent opinion piece. Early cancer trials showed high complete response rates…
    BioSpace · 16d agoPositive↗ source
  • Genentech strikes second Asia deal in a week, betting up to $1B in oncology ADC alliance with DualityBio
    Through its DualityBio deal, Roche's Genentech hopes to create antibody-drug conjugates with payloads that can circumvent growing cancer drug resistance.
    BioSpace · 16d agoDealNeutral↗ source
  • Revolution Medicines' Rasonge receives second-line pancreatic cancer nod, could drive $2.3B sales by 2028
    Revolution Medicines announced that its RAS inhibitor Rasonge earned a second-line indication for pancreatic ductal adenocarcinoma, marking the first regulatory step in the company's PDAC strategy.…
    BioSpace · 17d agoApprovalPositive↗ source
  • Obesity drug market surges as Lilly, Novo Nordisk lead and rivals chase $200B opportunity
    Eli Lilly and Novo Nordisk continue to dominate the early market for obesity treatments, expanding their prescription bases with new oral products. Meanwhile, a range of larger and smaller compani…
    BioSpace · 17d agoPositive↗ source
  • AstraZeneca and Amgen’s Tezspire shows positive results in Phase 3 eosinophilic esophagitis trial
    AstraZeneca and Amgen continue to co‑develop and co‑commercialize Tezspire, an anti‑inflammatory therapy already approved for asthma and chronic rhinosinusitis. The partners are preparing another F…
    BioSpace · 17d agoPositive readoutPositive↗ source
  • FDA greenlights first oral therapy for adult dermatomyositis
    The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets as a treatment for adults with dermatomyositis. Dermatomyositis is a rare autoimmune condition that attacks muscle…
    fda press · 17d agoApprovalPositive↗ source
  • FDA grants emergency use authorization for generic Bimectin injection to prevent screwworm in cattle
    The U.S. Food and Drug Administration announced an Emergency Use Authorization for the generic ivermectin product Bimectin injection, allowing its use to prevent New World screwworm infestations in…
    fda press · 17d agoRegulatoryPositive↗ source