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  • Replimune secures FDA accelerated approval for melanoma therapy Tudriqev
    Replimune announced that the FDA has granted accelerated approval to its melanoma therapy RP1, marketed as Tudriqev, after two earlier rejections and a third expedited review. The decision reflects…
    STAT · 3h agoApprovalPositive↗ source
  • BlossomHill and Latigo close IPO week with $496 million raised
    BlossomHill Therapeutics, a cancer‑focused biotech, completed its initial public offering this week. Latigo, a company developing non‑opioid pain treatments, also went public at the same time. To…
    Endpoints · 7h agoDealPositive↗ source
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Infectious Disease291
  • Third gender-affirming clinic settles with DOJ as Senate moves to hold Fauci in contempt
    A third clinic that provides gender-affirming services reached a settlement with the Department of Justice, ending a federal investigation into alleged civil-rights violations. The agreement inclu…
    STAT · 4h agoRegulatoryNeutral↗ source
  • FDA grants accelerated approval to Replimune’s melanoma therapy Tudriqev after two prior rejections
    The Food and Drug Administration has granted accelerated approval to Replimune’s RP1 treatment, which will be marketed under the name Tudriqev, for patients with advanced melanoma. An advisory com…
    STAT · 20h agoApprovalPositive↗ source
  • FDA approves first mRNA seasonal flu vaccine, mFlusiva, a year after funding cuts
    The U.S. Food and Drug Administration granted approval to mFlusiva, the first mRNA‑based seasonal influenza vaccine, after its advisory committee voted unanimously that the benefits outweigh the ri…
    STAT · 1d agoApprovalPositive↗ source
  • FDA approves Moderna flu vaccine
    The U.S. Food and Drug Administration granted approval to Moderna's seasonal flu vaccine, adding another product to the company's portfolio. The approval was announced late Wednesday, after a repo…
    Endpoints · 1d agoApprovalPositive↗ source
  • Revolution Medicines readies launch of experimental pancreatic cancer drug daraxonrasib as approval decision pending
    Revolution Medicines executives say they are preparing to launch daraxonrasib, an experimental therapy for metastatic pancreatic cancer. The drug is currently awaiting regulatory decisions in the…
    Endpoints · 1d agoNeutral↗ source
  • Context Therapeutics drops CT-95 bispecific T-cell engager to stretch cash runway to 2027
    Context Therapeutics announced it is halting development of its bispecific T-cell engager CT-95. The company acquired CT-95 in 2024 for $3.7 million and began dosing patients in a phase 1 trial in…
    Fierce Biotech · 1d agoNegative↗ source
  • Actimed regains full rights to S-oxprenolol, ends $126 million Faraday licensing deal
    Actimed Therapeutics announced it has reclaimed all worldwide rights to its experimental wasting disease drug S-oxprenolol, terminating the licensing agreement it had with Faraday Pharmaceuticals.…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • Chutes & Ladders—BioNTech brings in Sobi CEO
    After a six-month wait, BioNTech has finally filled its vacant CEO spot with Guido Oelkers, Ph.D. Oelkers hails from his tenure as CEO of Swedish pharma Sobi, where he oversaw the licensing of the…
    Fierce Biotech · 23h ago↗ source
  • Medicare GUARD pilot faces biotech push to spare rare disease drugs as Moderna begins first-in-human Ebola vaccine trial
    The Medicare Part D GUARD pilot, designed to lower retail drug prices, is under scrutiny because excluding rare disease medicines would erase most of the projected savings, according to STAT. Biot…
    STAT · 2d agoRegulatoryNeutral↗ source
  • Only one third of US prostate cancer patients received pre-biopsy MRI in 2022, far below Western norms
    MRI is considered the standard pre-biopsy imaging tool for prostate cancer in most western nations, yet a new analysis shows that only about a third of US cases used it in 2022. In the United Stat…
    STAT · 2d agoNegative↗ source
  • Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes
    Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product. The recall stems from a labeling mistake where the MicroVault contain…
    fda medwatch · 2d agoCRLNegative↗ source
  • AstraZeneca and Bristol Myers Squibb abandon merger talks
    Reuters reported that AstraZeneca and Bristol Myers Squibb have ended discussions about a possible merger and will not pursue a deal. The collapse of the talks removes a potential consolidation th…
    Endpoints · 2d agoDealNegative↗ source
  • Medicaid policy shift could alter primary therapy for children with autism
    The article notes that the main therapy used for children with autism may be affected by upcoming Medicaid policy changes. It highlights that the therapy, which is a cornerstone of treatment for ma…
    STAT · 2d agoRegulatoryNeutral↗ source
  • Eli Lilly removes Gaucher disease gene therapy trial from pipeline, citing unmet internal criteria
    Eli Lilly has announced the removal of a phase 1/2 study testing its GBA1 gene therapy for Gaucher disease type 1. The program was part of the assets acquired when the company bought Prevail Therap…
    Fierce Biotech · 2d agoNegative readoutNegative↗ source
  • Opinion: Films on assisted dying often ignore socioeconomic factors as New York law takes effect
    The piece, authored by Anna Magdalena Elsner and Vanessa Rampton, notes that New York's Medical Aid in Dying Act will become law on Aug 5, 2026, marking a major policy shift for terminally ill pati…
    STAT · 2d agoNeutral↗ source
  • Pathos AI acquires bispecific ADC from Alphamab and secures AstraZeneca partnership
    Pathos AI announced it will pay $125 million upfront for the rights to JSKN016, a bispecific TROP2/HER3 antibody‑drug conjugate from China’s Alphamab Oncology. The agreement also includes up to $2.…
    Fierce Biotech · 3d agoDealPositive↗ source
  • Lisata cuts 72% of workforce and sues Kuva after merger collapse
    Lisata, a solid tumor biotech, announced it is laying off roughly 72% of its employees, including its chief medical officer, as it reassesses its future. The cuts follow the collapse of a planned…
    Fierce Biotech · 3d agoLayoffsNegative↗ source
  • Pfizer drops two obesity programs, including Metsera-derived GLP-1 candidate, in pipeline cleanout
    Pfizer announced it is removing two clinical‑stage obesity programs as part of its quarterly pipeline cleanout. The first program, MET-224o, is an oral ultra‑long‑acting GLP‑1 receptor agonist tha…
    Fierce Biotech · 3d agoNegative↗ 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 · 3d agoDealPositive↗ source
  • Merck to test experimental sac-TMT antibody-drug conjugate with Keytruda in lung cancer trial
    Merck announced it will start a clinical trial testing its experimental antibody-drug conjugate sac-TMT together with the immunotherapy Keytruda in patients with lung cancer. The study will assess…
    Endpoints · 2d agoNeutral↗ source
  • Lilly expands access to its experimental obesity therapy while Jazz pulls Zepzelca's second-line lung cancer use
    Lilly announced it will broaden the expanded‑access program for its obesity drug that has not yet received regulatory approval, allowing more patients to receive the treatment under a compassionate…
    raps · 3d agoRegulatoryNeutral↗ source
  • Physician reflects on Quebec's assisted-suicide landscape through Josée Lamère’s story
    Sai Rajagopal, a Canadian physician and researcher, writes an opinion piece that follows the life of Josée Lamère, who became one of the 7.9 percent of Quebecers who have chosen assisted suicide. H…
    STAT · 3d agoNeutral↗ source
  • FDA expands Pluvicto label, allowing most metastatic prostate cancer patients to receive the therapy
    The U.S. Food and Drug Administration has approved an expanded label for Novartis’ radiopharmaceutical Pluvicto, permitting its use together with hormone therapy in metastatic prostate cancer. The…
    Endpoints · 4d agoApprovalPositive↗ source