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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
  • Latigo Biotherapeutics raises $345.6M in IPO to fund non-opioid pain drug pipeline
    Latigo Biotherapeutics, a Los Angeles-based biotech focused on non-opioid ion-channel-blocking pain therapies, completed an initial public offering on Thursday. The company sold 19.2 million share…
    BioPharma Dive · 4h agoDealPositive↗ source
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  • 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
  • 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
  • ‘Significant’ demand for Revolution drug; Intellia pinpoints liver toxicity culprit
    Early indicators from a compassionate use plan led analysts to hike projections for daraxonrasib. Elsewhere, Intellia believes it’s answered a key safety question and Arrowhead moved to catch a rival.
    BioPharma Dive · 2h ago↗ 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
  • Replimune's oncolytic virus therapy Tudriqev receives FDA accelerated approval for advanced melanoma
    The U.S. Food and Drug Administration has granted approval to Replimune's melanoma treatment, ending a series of earlier rejections after an advisory panel advocated for the drug. The therapy, pre…
    BioPharma Dive · 19h 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
  • Cardiac biotech Braveheart raises $382.5M in IPO, launches on Nasdaq as BRVE
    Braveheart Bio, a cardiac drug developer, priced its initial public offering on Wednesday and secured $382.5 million in proceeds. The company sold about 21.2 million shares at $18 each, exceeding t…
    BioPharma Dive · 1d agoDealPositive↗ 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
  • Gilead reports modest sales rise but analysts question future growth beyond HIV drugs
    Gilead's second‑quarter results showed total product revenue of $7.6 billion, up 8% year‑over‑year. The company's two leading HIV treatments, Biktarvy and Descovy, together generated about $5.7 bi…
    BioPharma Dive · 2d agoEarningsNeutral↗ 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
  • J&J pharma chief Jennifer Taubert to retire; Krystal Biotech shares plunge after gene therapy revenue shortfall
    Johnson & Johnson announced that Jennifer Taubert will step down as head of its pharmaceutical division after a 21‑year tenure. During her time she oversaw commercial strategy, dealmaking and the…
    BioPharma Dive · 3d agoNegative↗ 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