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  • FDA approves Scholar Rock's muscle-targeted SMA therapy Isembyld
    The Food and Drug Administration has approved a new medication for spinal muscular atrophy (SMA). The drug, apitegromab marketed as Isembyld, is the first muscle-targeted therapy for the disease.…
    BioPharma Dive · 3h agoApprovalPositive↗ source
  • Roche-MediLink’s B7-H3 ADC meets primary endpoint in phase 3 SCLC trial, median survival 13.3 months
    Roche and its partner MediLink reported phase 3 results for the B7-H3-directed antibody-drug conjugate (ADC) in small-cell lung cancer. The trial met its primary endpoint, with a median overall sur…
    Fierce Biotech · 11h agoPositive readoutNeutral↗ source
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Endocrinology & Metabolism497
Infectious Disease464
  • Cullinan and Taiho report six-month survival gain for EGFR exon 20 NSCLC in phase 3 trial
    Cullinan Therapeutics and Taiho Oncology presented interim data from their phase 3 Rezilient3 study, which evaluated the tyrosine kinase inhibitor zipalertinib combined with platinum‑based chemothe…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • BioNTech's gotistobart shows 18.5-month median survival in relapsed squamous lung cancer, beating docetaxel
    BioNTech presented updated data from its phase 3 Preserve-003 trial at the World Conference on Lung Cancer in Seoul. The trial compares its anti-CTLA-4 antibody gotistobart with standard chemothera…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • GSK’s risvutatug rezetecan shows 18.5-month median overall survival in phase 3 SCLC trial
    GSK, together with Chinese partner Hansoh Pharma, reported results of its antibody‑drug conjugate risvutatug rezetecan (ris‑rez) in a phase 3 trial for relapsed small‑cell lung cancer. The study e…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • Karyopharm Secures One-Month Debt Extension While Awaiting Xpovio Decision
    Karyopharm Therapeutics, facing cash constraints, has negotiated a temporary reprieve on a $15.8 million debt that was due. Under the agreement, lenders and noteholders will refrain from enforceme…
    BioPharma Dive · 3d agoDealNeutral↗ source
  • Takeda R&D chief Andy Plump to retire in June 2027, will stay on board through 2027
    Takeda announced that Andy Plump, who has led the company's research and development since 2015, will retire in June 2027. Plump will remain president of R&D until a successor is appointed and wil…
    BioPharma Dive · 4d agoNeutral↗ source
  • Solstice Oncology secures $225M Series A to advance CTLA-4 antibody porustobart in colon cancer
    Solstice Oncology, a biotech startup focused on immunotherapy, announced it has raised $225 million in a Series A financing round. The funding will support development of its lead candidate, a CTL…
    BioPharma Dive · 5d agoDealPositive↗ source
  • AstraZeneca’s IL-33 antibody tozorakimab earns FDA priority review after COPD trial cuts exacerbations by up to 34%
    AstraZeneca’s R&D chief medical officer Sharon Barr said the company’s latest data on its IL-33 inhibitor represents an internal “science success story.” The results have earned the drug a priority…
    Fierce Biotech · 6d agoPositive readoutPositive↗ source
  • Roivant reports record-breaking Phase 2 results for PH-ILD drug mosliciguat, starts Phase 3
    Roivant announced that its experimental drug mosliciguat met all primary and secondary endpoints in a Phase 2 study in patients with pulmonary hypertension associated with interstitial lung disease…
    BioPharma Dive · 5d agoPositive readoutPositive↗ source
  • Inhibrx reports 9.6-month median PFS for OX40 agonist combo in phase 2 head-neck cancer trial
    Inhibrx Biosciences presented updated data from its phase‑2 HexAgon study of the hexavalent OX40 agonist INBRX‑106 combined with Merck’s Keytruda in patients with untreated metastatic or unresectab…
    Fierce Biotech · 6d agoPositive readoutPositive↗ source
  • Roivant’s inhaled pulmonary hypertension drug mosliciguat shows strong Phase 2 results
    Roivant invested $14 million in Bayer's inhaled soluble guanylate cyclase activator mosliciguat after a $294 million biobucks agreement in 2024, and promptly advanced the candidate into a Phase 2 s…
    Fierce Biotech · 8d agoPositive readoutPositive↗ source
  • Ionis receives FDA approval for Zanvastro, the first treatment for Alexander disease, as Pfizer partners on new ADC program
    The U.S. Food and Drug Administration approved Zanvastro, marking the first approved medicine for the rare and often fatal neurological disorder Alexander disease. Developed by Ionis Pharmaceutical…
    BioPharma Dive · 10d agoApprovalPositive↗ source
  • Novartis' Lp(a) drug pelacarsen fails to cut heart attack or stroke risk in phase 3 trial
    Novartis, in partnership with Ionis, completed the phase 3 Lp(a)Horizon trial of pelacarsen, an antisense oligonucleotide designed to lower lipoprotein(a) levels. The study enrolled more than 8,30…
    Fierce Biotech · 9d agoNegative readoutNegative↗ source
  • Pfizer sells Seagen-derived ADC to Medicus Pharma for $12 million upfront, potential $1 billion milestones
    Pfizer has transferred rights to an antibody‑drug conjugate it acquired in its Seagen purchase to Medicus Pharma. Medicus will pay $12 million upfront and $15 million a year later, and Pfizer coul…
    Fierce Biotech · 11d agoDealPositive↗ source
  • GSK agrees $1.3 billion deal with Hutchmed for early-stage KRAS-EGFR cancer candidate
    GSK will pay $110 million upfront to Hutchmed as part of a deal that could reach $1.295 billion, giving GSK worldwide rights to develop and commercialize a preclinical oncology asset. The asset, i…
    Fierce Biotech · 11d agoDealPositive↗ source
  • GSK to spend up to $1.3 billion on Hutchmed's dual-target cancer therapy
    GSK announced a deal to acquire the majority rights to Hutchmed's experimental therapy HMPL-A830. The agreement includes an upfront payment of $110 million and potential milestone and royalty payme…
    BioPharma Dive · 11d agoDealNeutral↗ source
  • Akeso's ivonescimab shows survival advantage over Keytruda in Chinese lung cancer trial
    A new data cut from a study comparing ivonescimab, a bispecific antibody from China-based Akeso, with Merck's Keytruda in patients with non-small cell lung cancer was released. The interim results…
    BioPharma Dive · 11d agoPositive readoutPositive↗ source
  • Medline expands recall of reprocessed electrophysiology and ultrasound catheters due to contamination risk
    Medline Industries has issued an expanded recall that adds new lots of reprocessed electrophysiology and ultrasound catheters after the FDA identified possible residual particulates in the devices.…
    fda medwatch · 12d agoCRLNegative↗ source
  • TScan Therapeutics cuts 75% of staff to focus on preclinical solid tumor programs
    TScan Therapeutics said it will cut about three quarters of its workforce after pausing its hematological and autoimmune programs. The company will shift resources to its preclinical solid tumor p…
    Fierce Biotech · 12d agoLayoffsNegative↗ source
  • Moderna and Merck's mRNA cancer vaccine extends survival in phase 3 melanoma trial
    Merck and Moderna reported that their personalized mRNA cancer vaccine improved patient outcomes in a late-stage study. The phase 3 INTerpath-001 trial enrolled 1,137 patients who had surgery to r…
    Fierce Biotech · 12d agoPositive readoutPositive↗ source
  • Mid-size biotechs join White House Medicaid pricing program, gain tariff relief
    Nine mid-size drugmakers announced they will take part in the White House’s GENEROUS Medicaid pricing model, which ties U.S. Medicaid payments to the lowest prices paid abroad. In return, the comp…
    BioPharma Dive · 13d agoRegulatoryNeutral↗ source
  • Medline recalls neonatal and infant heated wire breathing circuits over connector failures
    Medline has issued a recall for specific neonatal and infant heated wire breathing circuits after identifying failures in the electrical connector. The FDA has classified the issue as potentially…
    fda medwatch · 13d agoCRLNegative↗ source
  • FDA clears updated COVID shots from Pfizer, Moderna and Novavax as Moderna raises $2.6 billion for cancer programs
    The FDA has granted limited approvals for updated versions of three COVID-19 vaccines aimed at the newly dominant XFG variant. The clearances cover Pfizer/BioNTech’s Comirnaty, Moderna’s mNEXSPIKE…
    BioPharma Dive · 17d agoRegulatoryPositive↗ source
  • Biotech Index Surges as IPOs and M&A Activity Accelerate in 2026
    The XBI biotech index, which had fallen to about $64 per share three years ago, has climbed back to near $170, almost doubling its value over the past year. Investor interest is reflected in a wav…
    BioPharma Dive · 17d agoPositive↗ source