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  • Scholar Rock receives FDA approval for apitegromab (Isembyld) to treat spinal muscular atrophy
    Scholar Rock announced FDA approval for its injectable drug apitegromab, marketed as Isembyld, for treating spinal muscular atrophy, a rare muscle-wasting condition. The approval follows earlier s…
    Endpoints · 7h agoApprovalPositive↗ source
  • Corbus reports phase 1b obesity data showing lower neuropsychiatric side effects for CB1 antagonist
    Corbus Pharmaceuticals released results from a phase 1b trial of its CB1 inverse agonist aimed at treating obesity. The study indicated the drug lowered rates of depression, anxiety, irritability a…
    Fierce Biotech · 8h agoPositive readoutPositive↗ source
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fda recalls71
fda medwatch63
fda press38
Vaccines1288
Psychiatry & CNS901
Ophthalmology521
Pain503
Endocrinology & Metabolism498
Infectious Disease464
  • Cellectis drops its allogeneic CAR-T candidates lasme-cel and eti-cel amid rising competition from in-vivo therapies
    Cellectis announced it is terminating development of its two allogeneic CAR-T programs, lasme-cel for B-cell acute lymphoblastic leukemia and eti-cel for non-Hodgkin lymphoma. The move reflects a…
    Fierce Biotech · 13h agoNegative↗ source
  • GSK reports 94% response rate for Jideytro in ROS1-positive lung cancer at World Conference
    GSK is moving a newly acquired lung-cancer drug, Jideytro, toward FDA review after presenting data at the World Conference on Lung Cancer. The conference data showed a 94% response rate when Jidey…
    Endpoints · 3h agoPositive readoutPositive↗ source
  • Sanofi-backed Electra Therapeutics targets $297 million IPO as Enhertu shows Phase 3 lung cancer success
    Electra Therapeutics, a biotech company supported by Sanofi, announced plans to raise roughly $297 million through an initial public offering. The firm hopes to launch the offering shortly after La…
    Endpoints · 3h agoDealPositive↗ source
  • GSK presents promising late-stage lung cancer data from two investigational drugs
    GSK highlighted late-stage results for two of its lung cancer candidates, reporting encouraging efficacy signals that could advance the programs toward regulatory review. The company shared the da…
    STAT · 5h agoPositive readoutNeutral↗ source
  • AstraZeneca's breast cancer drug camizestrant fails pivotal first-line trial
    AstraZeneca announced that its investigational breast cancer drug camizestrant did not meet primary endpoints in a pivotal Phase 3 trial evaluating it as a first-line treatment for advanced disease…
    STAT · 5h agoNegative readoutNegative↗ source
  • Eli Lilly halts early-stage obesity drug LY4064912 after failing to meet development criteria
    Eli Lilly announced it is ending development of its early-stage obesity candidate, LY4064912, after the phase 1 study did not achieve the company’s expectations. The first‑in‑human trial enrolled…
    Fierce Biotech · 6h agoNegative↗ source
  • AstraZeneca's Etcamah fails late-stage trial for early-stage breast cancer use
    AstraZeneca announced that its newly approved breast cancer therapy, Etcamah, did not meet its primary goals in a pivotal study aimed at expanding the drug's label. The trial evaluated Etcamah in…
    Endpoints · 7h agoNegative readoutNegative↗ source
  • Definium Therapeutics reports positive Phase 3 results for oral LSD anxiety drug DT120
    Definium Therapeutics announced Monday that its experimental oral LSD formulation, DT120, achieved positive outcomes in a Phase 3 trial targeting an anxiety disorder. The trial, the company's thir…
    Endpoints · 7h agoPositive readoutPositive↗ source
  • Definium’s LSD therapy cuts anxiety scores in second late-stage trial
    Definium Therapeutics reported that its LSD-based drug DT120 reduced anxiety symptoms in a second late-stage study. In the 12-week trial, patients receiving a 100-microgram dose saw an average 9.8…
    STAT · 7h agoPositive readoutPositive↗ source
  • Electra Therapeutics targets up to $342M IPO to fund phase 2/3 study of ipsoprubart for rare inflammatory syndrome
    Electra Therapeutics, based in South San Francisco, filed with the SEC indicating plans to sell 21.7 million shares at $14‑$16 each. The company expects net proceeds of about $296.6 million, poten…
    Fierce Biotech · 9h agoDealNeutral↗ 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 · 13h agoPositive readoutNeutral↗ source
  • GSK to close German vaccine plant and cut 650 jobs as flu vaccine demand falls
    GSK announced it will wind down its vaccine manufacturing site in Germany, ending operations at the facility. The decision follows a rigorous review and reflects a decline in demand for egg‑based…
    Endpoints · 2h agoLayoffsNegative↗ source
  • Pennsylvania reports third measles death this year, a 40-year-old woman in Jefferson County
    Pennsylvania officials confirmed a third measles-related death in the state this year, involving a 40-year-old woman in Jefferson County. Coroner Greg Furlong said the death was measles-related bu…
    STAT · 4h agoNegative↗ source
  • Third measles-related death reported in Pennsylvania amid ongoing outbreak
    A 40-year-old woman in Pennsylvania died from complications related to measles, marking the third measles-related fatality in the state in recent weeks. The death was confirmed by Jefferson County…
    STAT · 6h agoNegative↗ source
  • Novo Nordisk rebrands as "Novo" to signal renewed focus amid slipping market share
    Novo Nordisk announced it will drop "Nordisk" from its name, adopting the shorter brand "Novo" along with a new slogan "Lasting Health Starts Now" as part of a cultural shift. The company says the…
    STAT · 9h agoNegative↗ source
  • Hospital leaders say GOP's $50 billion rural health fund falls far short of Medicaid cuts
    Republican lawmakers added a $50 billion Rural Health Transformation Fund to the tax‑cut legislation, aiming to help hospitals cope with planned Medicaid cuts. The fund represents only about 5 % o…
    STAT · 10h agoRegulatoryNegative↗ source
  • Republicans push $500 cash checks for ACA enrollees, highlighting cash-first health policy and GLP-1 drug surge
    Bob Herman’s STAT+ newsletter examines how the Trump administration is issuing $500 checks to a narrow group of Affordable Care Act participants just before the midterm elections. The move reflects…
    STAT · 2h agoRegulatoryNeutral↗ source
  • Novo Nordisk rebrands as 'Novo' and launches new culture strategy after recent setbacks
    Novo Nordisk announced it will drop "Nordisk" from its public brand, opting to be known simply as "Novo" starting Monday. The name change is part of a broader cultural overhaul aimed at revitalizi…
    Endpoints · 6h agoNeutral↗ source
  • Opinion: Restoring public trust in science requires humility and collaboration, not just better messaging
    Michelle Groman and Caroline Montojo, presidents of The Greenwall Foundation and the Dana Foundation, wrote an opinion piece on Sept. 14, 2026 about the challenge of rebuilding public trust in scie…
    STAT · 10h agoNeutral↗ source
  • Novo rebrands, drops 'Nordisk' to become simply 'Novo' in market push
    Novo Nordisk announced a major rebranding that will see the company drop the "Nordisk" part of its everyday brand. The legal name Novo Nordisk A/S remains unchanged, but the company will be known s…
    Fierce Biotech · 11h agoPositive↗ source
  • Football fan wrestles with love for the game amid rising CTE concerns
    Michael Arkush, a sportswriter and New York Giants fan, reflects on his excitement for the 2026 season while confronting the growing awareness of chronic traumatic encephalopathy (CTE) in football.…
    STAT · 10h agoNeutral↗ source
  • BioNTech says CTLA-4 drug nearly doubled survival times for lung cancer
    BioNTech delivered a compelling piece of evidence Monday supporting the development of its CTLA-4 antibody gotistobart in lung cancer. Previously treated lung cancer patients who received the CTLA-…
    Endpoints · 14m ago↗ source
  • FDA looks into reassessing criteria around rare disease trials, endpoint selection
    As more rare disease treatments make their way to the FDA, the agency on Monday called for further outside input as it grapples with how much efficacy and safety data are sufficient to inform an ...
    Endpoints · 36m ago↗ source