pharmadog
News
when
  • Latest
  • Archive
by source
  • All Sources
  • Sources Page
Jobs
department
  • Clinical
  • Regulatory
  • Medical Affairs
  • Commercial
  • R&D / Discovery
  • Biostatistics / Data
  • Manufacturing / CMC
  • Market Access
therapeutic area
  • Oncology
  • Immunology
  • Neuroscience
  • Cardiovascular
  • Metabolic
  • Rare Disease
  • Infectious Disease
location & type
  • Remote Only
  • US Only
  • California
  • Massachusetts
  • Internships
  • Phase 3 Roles
  • All Jobs →
Drugs
by stage
  • Marketed
  • Phase 3
  • Phase 2
  • Phase 1
  • Preclinical
browse
  • Most catalysts
  • Recently active
  • All drugs →
  • Companies
  • Patent cliff
Calendar
what
  • Trial readouts
  • PDUFA dates
  • Approvals
  • Earnings
when
  • Upcoming
  • Month grid
  • Recently passed
Sign InSubscribe
pharmadog

fetch the data · sniff the signal

Discover
  • Jobs
  • News
  • Drugs
  • Calendar
  • Companies
Hubs
  • Topics
  • Patent cliff
  • Publications
  • Readouts
Tools
  • Compare
  • Search
  • Bookmarks
Trust
  • About
  • Sources
  • Contact
Legal
  • Privacy
  • Terms
  • Pricing

© 2026 pharmadog.xyz

made by humans and a good dog

  • home
  • jobs
  • news
  • search
pharmadog news

Browse

1,836 stories matching this filter · ← front page

★ save view↓export CSV
rangeto
sort
recentoldestsourcealpha
source
STAT1801Endpoints1403Fierce Biotech720BioSpace712BioPharma Dive530raps239onclive165fda recalls114fda medwatch
therapy area
allOncology12439Rare Disease3241Immunology2905Cardiology2788Hematology2197Pulmonology2150Vaccines
  • Zura Bio halts hidradenitis suppurativa program after tibulizumab fails phase 2 trial
    Zura Bio announced it is ending development of tibulizumab for hidradenitis suppurativa after the drug did not meet the primary endpoint in a phase 2 study. The trial, called Tibushield, compared t…
    Fierce Biotech · 3d agoNegative readoutNegative↗ source
  • Vir Biotechnology's Phase 3 Trial Shows Primary Endpoint Success in Chronic Hepatitis Delta
    Vir Biotechnology reported that its phase 3 Eclipse 1 trial in chronic hepatitis delta met the primary endpoint. At week 48, 44% of patients who began treatment immediately showed undetectable HDV…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
← prev
page 4 of 74
next →
112
globenewswire health73
fda press59
1818
Psychiatry & CNS1212
Ophthalmology1074
Endocrinology & Metabolism782
Pain780
Nephrology764
  • Valneva's Shigella vaccine cuts infection rates in phase 2 trial
    Valneva reported that its Shigella vaccine reduced the number of intestinal infections in a phase 2 controlled human infection model study conducted in the United States. The trial enrolled 120 he…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • FDA cuts required analytical tests for emergency-use diagnostic devices in new guidance
    On 9 November 2026 the U.S. Food and Drug Administration released final guidance aimed at simplifying validation of in-vitro diagnostic devices used in public-health emergencies. The document outli…
    raps · 4d agoRegulatoryPositive↗ source
  • Phase 3 trial shows Zealand-Boehringer obesity drug survodutide does not raise cardiovascular death risk
    The Phase 3 SYNCHRONIZE-CVOT study found that survodutide, the joint obesity therapy from Zealand and Boehringer Ingelheim, was non‑inferior to placebo for cardiovascular death, indicating no added…
    BioSpace · 3d agoPositive readoutNeutral↗ source
  • Kyorin signs $140M deal for Japan rights to Edesa's ARDS antibody
    Kyorin Pharmaceutical will pay $12 million up front and up to $134 million in milestones, plus royalties, for exclusive Japan rights to Edesa Biotech’s anti‑TLR4 antibody, paridiprubart, intended f…
    Fierce Biotech · 3d agoDealPositive↗ source
  • Gene therapy sponsors urged to address six GMP manufacturing considerations early
    SK pharmteco’s chief technical officer Tatiana Nanda explained that gene therapy sponsors need to think about manufacturing issues well before reaching GMP production. She told BioSpace that early…
    BioSpace · 3d agoNeutral↗ source
  • FDA reduces required analytical tests for emergency-use diagnostic devices
    The FDA finalized new guidance aimed at streamlining validation for in-vitro diagnostic (IVD) devices that detect emerging pathogens during public-health emergencies. The guidance lowers the numbe…
    raps · 4d agoRegulatoryNeutral↗ source
  • Spruce Biosciences spins out preclinical endocrinology program into new unit Adrenyx, backed by up to $50 million
    Spruce Biosciences announced it is creating a separate subsidiary to house its preclinical endocrinology research. The new company, named Adrenyx Biosciences, will focus on advancing the early-sta…
    Fierce Biotech · 3d agoDealNeutral↗ source
  • Update: FDA investigates Novartis' Zolgensma following 9 cases of tumors in treated patients
    After Novartis confirmed the reports of tumors in patients who have been treated with the spinal muscular atrophy gene therapy, the FDA will determine if any regulatory action is needed for Zolgens…
    BioSpace · 3d ago↗ source
  • Recon: FDA orders new eye risk warnings for Ozempic, Zepbound; FDA launches investigation of Novartis’ Zolgensma after cancer ca...
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 4d ago↗ source
  • Chinese biotech CEOs target creation of up to ten global Big Pharma firms within a decade
    Chinese drug developers have shifted from generic manufacturing to aiming for a seat at the global Big Pharma table, according to recent interviews. The country now ranks second after the United S…
    Fierce Biotech · 5d agoPositive↗ source
  • Merck and Moderna report 99% manufacturing success and 42% lower recurrence risk for personalized melanoma vaccine in Phase 3 trial
    Merck and Moderna announced that their personalized mRNA cancer vaccine, combined with Keytruda, was successfully manufactured for 99% of patients enrolled in a large Phase 3 study. The trial, call…
    BioSpace · 6d agoPositive readoutPositive↗ source
  • Moderna reports 29% revenue rise as COVID vaccine sales stay steady amid global uptake
    Moderna said its quarterly revenue jumped 29% to $1.3 billion, driven by continued demand for its COVID-19 shots. The company has generated $1.8 billion in revenue so far this year, according to CF…
    BioSpace · 6d agoEarningsPositive↗ source
  • Marea Therapeutics reports promising Phase 2b results for MAR001 in hypertriglyceridemia
    Marea Therapeutics, which recently merged with oncology firm Lisata Therapeutics, disclosed data from the first part of its phase 2b trial of the drug candidate MAR001. The study enrolled patients…
    Fierce Biotech · 6d agoPositive readoutPositive↗ source
  • Boehringer targets 2027 submission of obesity drug survodutide after positive cardiovascular trial
    Boehringer Ingelheim announced that its experimental obesity therapy survodutide is moving toward regulatory filing. The move follows the drug's successful phase 3 cardiovascular outcomes study, w…
    Fierce Biotech · 6d agoPositive readoutPositive↗ source
  • Experts warn US Treasury's biotech investment ban on China could backfire
    The U.S. Treasury released a draft policy to implement the Comprehensive Outbound Investment National Security (COINS) Act, proposing to add pharmaceutical compounds to an outbound investment black…
    Fierce Biotech · 6d agoRegulatoryNegative↗ source
  • Forge Biologics VP sees AI and Ohio talent driving next wave of gene therapy manufacturing
    Samantha Piteri-Molina, vice president of business and strategy at Forge Biologics, said her focus is on getting gene therapies into patients' hands. She helped steer Forge through a $620 million…
    BioSpace · 6d agoPositive↗ source
  • Agios cuts over 35% of R&D staff as FDA decision on sickle cell drug is delayed
    Agios announced it will eliminate more than 100 R&D positions, representing over a third of its research staff, after the FDA postponed a decision on its sickle cell disease candidate. The company…
    BioSpace · 6d agoLayoffsNegative↗ source
  • Sarepta CEO Sees Path to Stronger DMD Trials Amid 2025 Elevidys Setbacks
    Sarepta Therapeutics’ newly appointed chief executive Michael Severino, after a 90‑day assessment period, outlined a plan to restore the company’s leadership in the Duchenne muscular dystrophy mark…
    BioSpace · 6d agoEarningsNeutral↗ source
  • Moderna pauses norovirus vaccine trial after missing interim analysis
    Moderna announced it will not enroll a new cohort in the phase 3 trial of its mRNA-1403 norovirus vaccine. The decision follows a July interim analysis that showed the vaccine missed its predefine…
    Fierce Biotech · 6d agoNegative readoutNegative↗ source
  • Faeth Therapeutics reports 33% response rate in phase 2 endometrial cancer combo trial
    Faeth Therapeutics presented topline results from its phase 2 study of an oral combination targeting the PI3K/AKT/mTOR pathway in patients with advanced or recurrent endometrial cancer. The regimen…
    Fierce Biotech · 6d agoPositive readoutPositive↗ source
  • Merck ends Sutro partnership on IL-2 agonist MK-1484 amid routine pipeline prioritization
    Merck announced it is discontinuing development of MK-1484, an interleukin-2 agonist created in partnership with Sutro Biopharma. The drug entered clinical testing in 2022 as a monotherapy and in…
    Fierce Biotech · 6d agoNegative↗ source
  • Siemens Healthineers to spin off in‑vitro diagnostics unit as Olyrian Diagnostics, rebranding to Healthineers
    Siemens Healthineers announced it will separate its in‑vitro diagnostics division into a new standalone company called Olyrian Diagnostics. The carve‑out will run in parallel with a corporate name…
    Fierce Biotech · 6d agoDealNeutral↗ source
  • Regulators urge risk-based lifecycle approach for AI tools amid election-linked FDA uncertainty
    A panel of regulatory experts at the RAPS AI in Regulatory Conference in Barcelona urged professionals using AI tools to adopt a risk-based, life-cycle perspective rather than focusing solely on va…
    raps · 7d agoRegulatoryNeutral↗ source