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21 stories matching this filter · ← front page

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allOncology5950Rare Disease1401Cardiology1087Hematology1008Immunology991Pulmonology892Vaccines
  • Leo Pharma signs $435 million deal with Tanabe for rare skin disease drug dersimelagon
    Leo Pharma announced a licensing agreement with Mitsubishi Tanabe Pharma for worldwide rights to dersimelagon, an oral melanocortin-1 receptor agonist targeting rare genetic skin disorders. The dr…
    Fierce Biotech · 3d agoDealPositive↗ source
  • Eli Lilly signs up to $370M ion-channel collaboration with OmniAb
    Eli Lilly has entered a collaboration with antibody platform company OmniAb that could involve up to $370 million in research, development and commercial milestone payments. OmniAb, which was spun…
    Fierce Biotech · 3d agoDealPositive↗ source
73
fda recalls47
fda medwatch36
fda press28
885
Psychiatry & CNS710
Ophthalmology419
Endocrinology & Metabolism377
Pain371
Infectious Disease346
  • MoonLake reports all endpoints met in phase 3 trial of sonelokimab for psoriatic arthritis
    MoonLake Immunotherapeutics said its lead nanobody sonelokimab achieved positive topline results in a phase 3 study of patients with psoriatic arthritis. At week 16, 42.1% of participants reached…
    Fierce Biotech · 10d agoPositive readoutPositive↗ source
  • BlossomHill and Latigo Biotherapeutics raise over 30% beyond IPO targets
    Two emerging biotech companies surpassed their initial public offering expectations on Friday, with both BlossomHill Therapeutics and Latigo Biotherapeutics raising at least 30% more capital than p…
    Fierce Biotech · 13d agoDealPositive↗ source
  • Latigo Biotherapeutics targets non-opioid pain market with $247 M IPO
    Latigo Biotherapeutics announced details of its planned initial public offering, aiming to raise roughly $247 million to advance its pipeline of non-opioid pain treatments. The company intends to…
    Fierce Biotech · 16d agoDealPositive↗ source
  • Analyst warns AstraZeneca-BMS merger could spark regulatory hurdles and job cuts
    Angus Liu writes an editorial warning that talks of a merger between AstraZeneca and Bristol Myers Squibb could create more problems than benefits. He notes that the two companies have only discuss…
    Fierce Biotech · 17d agoDealNegative↗ source
  • OKYO Pharma CSO Raj Patil boosts stake to 20,030 shares
    OKYO Pharma, a clinical stage biotech focused on neuropathic corneal pain and anterior segment eye diseases, disclosed that its chief scientific officer, Raj Patil, PhD, bought additional shares.…
    globenewswire health · 23d agoDealNeutral↗ source
  • Australia's TGA adopts 23 international scientific guidelines from EMA, ICH and FDA
    The Therapeutic Goods Administration (TGA) in Australia announced it has formally adopted 23 scientific guidelines. The guidelines come from the European Medicines Agency, the International Counci…
    raps · 24d agoRegulatoryNeutral↗ source
  • FDA advisory panel recommends adding peptides BPC-157 and KPV to bulk compounding list
    An FDA advisory committee voted 8-6, with one abstention, to recommend that two experimental peptides – BPC-157 for ulcerative colitis and KPV for wound and inflammatory conditions – be placed on t…
    raps · 27d agoRegulatoryNeutral↗ source
  • FDA advisory panel adds six peptides to compounding bulk drug list, rejects one
    The FDA’s advisory committee concluded a two-day meeting on Friday, reviewing seven peptide drug substances for inclusion on the agency’s bulk-drug compounding list. Committee members voted to add…
    raps · 27d agoRegulatoryNeutral↗ source
  • Eli Lilly’s retatrutide meets primary goals in phase 3 obesity trials with ~22% weight loss but no clear heart benefit
    Eli Lilly reported that its triple‑hormone agonist retatrutide achieved the primary endpoints in two phase 3 obesity studies, TRIUMPH‑2 and TRIUMPH‑3. The drug was tested at a 12 mg dose against pl…
    Fierce Biotech · 28d agoPositive readoutNeutral↗ source
  • Celldex halts skin disease program after barzolvolimab fails phase 2 trial
    Celldex Therapeutics announced it is discontinuing development of its anti‑KIT antibody barzolvolimab for chronic skin disorders after the drug failed to meet its primary endpoint in a phase 2 stud…
    Fierce Biotech · 29d agoNegative readoutNegative↗ source
  • Kolon’s cell-based gene therapy misses key endpoints in phase 3 osteoarthritis trial
    Kolon TissueGene reported that its phase 3 study of TG‑C, a cell‑based gene therapy for knee osteoarthritis, failed to meet its co‑primary endpoints. Patients receiving the therapy showed no statis…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Latigo Biotherapeutics plans IPO to fund phase 3 trials of non-opioid pain drug LTG-001
    Latigo Biotherapeutics announced it is preparing an initial public offering to raise capital for its clinical-stage, non-opioid pain management pipeline. The company highlighted its oral Nav1.8 in…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Biotronik Neuro acquires Soin Neuroscience spinal cord stimulation patent portfolio to boost next-gen pain therapy
    Biotronik Neuro, the neuromodulation arm of Berlin-based medtech firm Biotronik, announced it has purchased a collection of spinal cord stimulation patents from Ohio-based Soin Neuroscience. The a…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Honesty and Humor Provide Hope in Breast Cancer Survivorship: With Sara Nunnery, MD, MSCI; and Annie Bond
    Dr Nunnery and Annie Bond discuss breast cancer survivorship and patient advocacy.
    onclive · 3mo ago↗ source
  • Dr Randall on the Rationale for Investigating CSF-1R Inhibition in TGCT
    R. Lor Randall, MD, FACS discusses safety and efficacy data from the MANEUVER trial, which evaluated pimicotinib in TGCT.
    onclive · 3mo ago↗ source
  • The OncFive: Top Oncology Articles for the Week of 5/3
    The FDA clears zenocutuzumab in NRG1 fusion+ cholangiocarcinoma, accepts a taletrectinib NDA in ROS1+ NSCLC for review, and more.
    onclive · 3mo ago↗ source
  • Dr Randall on Long-Term Responses and Functional Benefits With Pimicotinib in TGCT
    R. Lor Randall, MD, FACS discusses safety and efficacy data from the MANEUVER trial, which evaluated pimicotinib in TGCT.
    onclive · 3mo ago↗ source
  • FDA Approves Zenocutuzumab for NRG1 Fusion+ Cholangiocarcinoma
    onclive · 3mo ago↗ source
  • MANEUVER Trial Underscores Potential Paradigm Shift Toward Targeted Approaches in TGCT
    R. Lor Randall, MD, FACS, discusses how the introduction of systemic therapies like pimicotinib in TGCT enables a tumor biology–informed approach to care.
    onclive · 3mo ago↗ source