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 →
Sign InSubscribe
pharmadog

fetch the data · sniff the signal

Discover
  • Jobs
  • News
Hubs
  • Topics
  • Patent cliff
  • Publications
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

846 stories matching this filter · ← front page

★ save view↓export CSV
rangeto
sort
recentoldestsourcealpha
source
STAT1044Endpoints792BioPharma Dive304BioSpace225Fierce Biotech213onclive165raps78globenewswire health
therapy area
allOncology6170Rare Disease1498Cardiology1115Hematology1053Immunology1034Vaccines939
  • Roche's Genentech signs up to $2.3B deal with Hanmi for weight-loss drug that preserves lean mass
    Roche, through its Genentech subsidiary, has entered a licensing agreement with South Korea's Hanmi Pharm that could be worth up to $2.3 billion, including a $190 million upfront payment. The deal…
    BioSpace · 3h agoDealPositive↗ source
  • FDA places hold on REGENXBIO's Hunter syndrome gene therapy after spinal nodules found, company pauses resubmission
    The FDA placed a clinical hold on RGX-121, REGENXBIO's gene therapy for Hunter syndrome, after MRI scans showed small nodules or cystic masses in the spines of five trial participants. The finding…
    BioSpace · 3h agoRegulatoryNegative↗ source
← prev
page 1 of 34
next →
73
fda recalls49
fda medwatch43
fda press28
Pulmonology918
Psychiatry & CNS741
Ophthalmology431
Pain409
Endocrinology & Metabolism392
Infectious Disease369
  • FDA’s new leadership aims to restore reliability, but each application remains judged on its data
    The FDA’s current leadership is working to rebuild the agency’s reputation for reliability, integrity and transparency after a turbulent period under former commissioner Marty Makary. Recent actio…
    BioSpace · 12h agoRegulatoryNeutral↗ source
  • Health Secretary Kennedy criticizes CDC vaccine classification scheme and shared decision-making category
    Robert F. Kennedy Jr., serving as Health Secretary, has raised concerns about how the CDC categorizes vaccine recommendations. The CDC uses three categories: routine recommendations for universal…
    BioSpace · 4h agoRegulatoryNegative↗ source
  • Boehringer Ingelheim pauses Phase 1 study of oral candidate BI 3031185 after safety event
    Boehringer Ingelheim has placed a Phase 1 study of its oral candidate BI 3031185 on hold after a safety event was identified. The trial, run in Japan with healthy volunteers, was assessing tolerab…
    BioSpace · 5h agoCRLNegative↗ source
  • Capricor’s Duchenne therapy has new life after FDA grants 3-month extension
    The FDA has granted a three-month extension for Capricor Therapeutics’ Duchenne muscular dystrophy hopeful deramiocel in order to review additional data and consider a refined indication. The new t…
    BioSpace · 1h ago↗ source
  • Qiagen appoints new chief executive after 9-month search
    Molecular diagnostics specialist Qiagen has a new CEO as Jonathan M. Pratt takes the reins.
    Fierce Biotech · 6h ago↗ source
  • TME holds onto $1B dream for brain cancer drug as search for partners nears conclusion
    TME Pharma’s hunt for a partner for its brain cancer drug is closer to bearing fruit as the German biotech clings onto its hope of generating $1 billion in peak sales from the asset.
    Fierce Biotech · 6h ago↗ source
  • Spruce’s successful FDA talks plant seeds for Q4 filing of ultra-rare disease drug
    Spruce Biosciences has taken another step toward filing for FDA approval of its ultra-rare disease drug candidate, ticking off some of the manufacturing tasks needed to submit the long-awaited appl…
    Fierce Biotech · 6h ago↗ source
  • Regenxbio gene therapy refiling plan derailed by FDA hold over spine MRI findings
    The FDA has put a clinical hold on Regenxbio’s RGX-121 over asymptomatic spine MRI findings, derailing the biotech’s plans to refile for approval of the once-rejected gene therapy candidate.
    Fierce Biotech · 9h ago↗ source
  • Roche, Eli Lilly net FDA approval for first-of-its-kind Alzheimer’s biomarker blood test
    Roche and Eli Lilly have won FDA clearance for their latest Alzheimer’s disease diagnostic.
    Fierce Biotech · 9h ago↗ source
  • Roche pens $2.5B pact for Hanmi’s clinical-stage obesity drug targeting less-explored mechanism
    Roche has taken its obesity strategy into uncharted territory via a $190 million upfront payment for a clinical-stage urocortin-2 analog from South Korea’s Hanmi Pharm.
    Fierce Biotech · 12h ago↗ source
  • Early Alert: Convenience Kit Issue from AVID Medical
    Certain AVID Medical convenience kits containing recalled BD ChloraPrep applicators should be removed from use due to potential fungal contamination
    fda medwatch · 12h ago↗ source
  • Early Alert: Convenience Kit Issue from Medline
    Certain Medline convenience kits containing recalled BD ChloraPrep applicators should be removed from use due to potential fungal contamination
    fda medwatch · 12h ago↗ source
  • Everything Sprouts recalls alfalfa sprouts over possible E. coli and Salmonella contamination
    Everything Sprouts, LLC, a Minneapolis‑based producer, announced a recall of certain lots of its alfalfa sprouts on August 22, 2026. The recall was triggered because the sprouts may be contaminate…
    fda recalls · 2d agoCRLNegative↗ source
  • US lawmakers push FDA to tighten rules on Chinese clinical data after three gene therapy deaths
    Three recent deaths in separate gene‑therapy trials in China have prompted two members of the U.S. House of Representatives to call on the FDA for new safeguards. Representatives John Moolenaar an…
    BioSpace · 3d agoRegulatoryNegative↗ source
  • Werewolf Therapeutics merges with Ambros in $150M deal to advance non‑opioid painkiller for rare limb injury syndrome
    Werewolf Therapeutics and Ambros Therapeutics announced a merger valued at $150 million, creating a new company that will retain the Ambros name. The deal includes a private placement to fund the…
    BioSpace · 3d agoDealPositive↗ source
  • Novo Nordisk launches Phase 3 trial of lower maintenance doses of oral Wegovy for obesity
    Novo Nordisk has begun a Phase 3, placebo-controlled study called OASIS 5 to evaluate two lower oral doses of its GLP-1 weight-loss drug Wegovy (semaglutide) in people who are obese or overweight.…
    BioSpace · 3d agoCRLNeutral↗ source
  • Ambros Therapeutics merges with Werewolf, raises $150M to fund phase 3 trial of rare disease drug
    Ambros Therapeutics announced an all‑stock reverse merger with Werewolf Therapeutics, accompanied by a $150 million private placement. The transaction will see the combined company operate under th…
    Fierce Biotech · 3d agoDealPositive↗ source
  • FDA issues early alert on Medical Action epidural kits containing recalled sodium chloride ampules
    The FDA’s Center for Devices and Radiological Health has posted an Early Alert warning about certain epidural kits from Medical Action Industries. The alert notes that the kits include sodium chlor…
    fda medwatch · 3d agoRegulatoryNegative↗ source
  • Capricor shareholders face board overhaul push as investors demand meeting and capital-preservation plan amid DMD cell therapy delay
    Kaos Capital, describing itself as a significant shareholder of Capricor Therapeutics, sent a letter to fellow investors calling for an immediate meeting, a change of the board, and a capital-prese…
    BioSpace · 2d agoNegative↗ source
  • FDA alerts recall of Medline neonatal heated wire breathing circuits over connector failures
    The FDA's Center for Devices and Radiological Health issued an Early Alert to warn the public about a high‑risk issue with Medline's neonatal and infant heated wire breathing circuits. The problem…
    fda medwatch · 3d agoCRLNegative↗ source
  • Early Alert: Portrait Core Services Software Issue from GE HealthCare
    Patients monitored on Portrait Mobile devices can be discharged (removed) from the Portrait monitoring system during an update to the Portrait Core Services software.
    fda medwatch · 3d agoRegulatoryNeutral↗ source
  • Fromm Family Foods recalls over 5,800 cases of wet dog food in US and Canada over possible metal contamination
    Fromm Family Foods LLC announced on August 21, 2026 that it is voluntarily recalling 3,852 cases of its Turkey Pâté Wet dog food and 1,973 cases of its Diner Classics Milo's Meatloaf Pâté Wet dog f…
    fda recalls · 2d agoRegulatoryNegative↗ source
  • Merck and Moderna’s melanoma vaccine shows positive Phase 3 results, boosting investor confidence
    Merck and Moderna announced that their personalized melanoma vaccine met the primary endpoint of recurrence‑free survival in a Phase 3 trial when given together with Keytruda. The study showed pati…
    BioSpace · 4d agoPositive readoutPositive↗ source