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2,162 stories matching this filter · ← front page

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  • Eli Lilly's retatrutide shows strong weight loss but no clear heart risk reduction in Phase 3 trial
    Eli Lilly released new data from a Phase 3 trial of retatrutide, its next‑generation obesity drug. The study enrolled nearly 2,000 participants with severe obesity and existing heart disease, some…
    STAT · 21d agoNegative readoutNegative↗ source
  • Most FDA-approved drugs meet postmarketing study requirements, and advisory panel backs two peptides for bulk compounding
    A recent analysis published in JAMA Network Open found that nearly nine out of ten drugs approved by the U.S. Food and Drug Administration have completed their postmarketing requirements or commitm…
    raps · 21d agoRegulatoryNeutral↗ source
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  • EMA moves quickly to enforce clinical trial result reporting across Europe
    The European Medicines Agency announced new measures aimed at ensuring that results of clinical trials are posted publicly in line with legal obligations. The steps follow an analysis that found f…
    STAT · 21d agoRegulatoryPositive↗ source
  • Sanofi's Lantus Solostar insulin pen faces supply challenges, patients struggle to find product
    Sanofi's Lantus Solostar pen, a long-acting insulin glargine product, has become hard to locate in pharmacies. The company says demand has risen due to broader market dynamics, and while the FDA h…
    STAT · 21d agoNegative↗ source
  • Congress rushes health-care bills on price transparency and prior authorization before August recess
    Congress is trying to pass a bundle of health-care legislation in the final week before the House and Senate adjourn for the August recess. Lawmakers are focusing on measures that would increase p…
    STAT · 21d agoRegulatoryNeutral↗ source
  • FDA advisory panel to decide on compounding of synthetic peptides amid safety concerns
    The FDA advisory committee is meeting to consider whether compounding pharmacies should be allowed to manufacture seven specific synthetic peptides. Use of these peptides has grown in the United St…
    STAT · 21d agoRegulatoryNeutral↗ source
  • Merck CEO warns Congress that restricting US-China biotech deals could cost America its biotech leadership
    Merck CEO Rob Davis told Congress and the Trump administration that limiting or cutting off US-China dealmaking would jeopardize US biotech leadership. He emphasized that collaboration with Chines…
    Endpoints · 21d agoRegulatoryNegative↗ source
  • Scancell to merge into Neuphoria and seek $89 million equity as AstraZeneca's breast cancer drug gains EU approval
    Scancell announced it will merge into Neuphoria Therapeutics, taking over Neuphoria's Nasdaq listing ($NEUP) and planning to change the ticker to SCLT. The combined entity aims to raise up to $89 m…
    Endpoints · 21d agoDealPositive↗ source
  • BeOne invests $300 million in New Jersey plant, adding small-molecule capacity and 120 jobs
    BeOne Medicines announced a $300 million investment to expand its manufacturing campus in Hopewell, New Jersey. The expansion will include a three‑story, 145,000‑square‑foot building for small‑mol…
    BioSpace · 21d agoDealPositive↗ source
  • Senate health committee delays vote on Trump nominee for ASPR amid anti-vaccine controversy
    The Senate health committee postponed its vote on Sean Kaufman, the Trump administration’s pick to lead the Office of the Assistant Secretary for Preparedness and Response (ASPR). The delay came ju…
    STAT · 21d agoRegulatoryNegative↗ source
  • Biogen looks to Apellis acquisition to boost lagging Leqembi sales
    Biogen CEO Chris Viehbacher said the company's Alzheimer's drug Leqembi has underperformed since its 2023 launch. The drug, co-developed with Eisai, has struggled to meet sales expectations, promp…
    Endpoints · 21d agoDealNeutral↗ source
  • Medicare proposal threatens funding for remote patient monitoring programs
    Medicare announced a proposal to sharply reduce reimbursement for remote patient monitoring services, reversing earlier policy support. The change would cut payments to firms that supply technolog…
    Endpoints · 21d agoRegulatoryNegative↗ source
  • HHS, FDA and partners to convene experts on clinical AI standards
    The White House, the Department of Health and Human Services, the FDA and the Office of the National Coordinator for Health Information Technology are bringing together experts to discuss how clini…
    STAT · 21d agoRegulatoryNeutral↗ source
  • Roche says its late-stage pipeline is full, sees growth through 2030
    Roche's CEO Thomas Schinecker told analysts that the company has 19 investigational medicines that could launch by 2030, indicating a robust late-stage pipeline. He added that the depth of the pip…
    BioSpace · 21d agoEarningsPositive↗ source
  • FDA peptide panel faces clash as Ebola outbreak kills over 1,000 and vaccine options remain limited
    The FDA is holding a two‑day panel on peptide therapeutics, and observers anticipate heated debate among regulators and industry. The African CDC reports the fastest‑growing Ebola outbreak, with m…
    STAT · 21d agoRegulatoryNeutral↗ source
  • Biopharma firms must prioritize hiring and retaining commercial talent for successful drug launches
    A BioSpace webinar brought together commercial leaders and a recruiting specialist to discuss how biopharma companies can better hire and keep commercial staff as they prepare for new product launc…
    BioSpace · 21d agoNeutral↗ source
  • Biopharma layoffs must double in second half of 2026 to match 2025 cuts
    The first half of 2026 saw biopharma companies cut slightly fewer jobs than the same period a year earlier, with layoffs affecting about 2% fewer employees overall. To reach the total workforce re…
    BioSpace · 21d agoLayoffsNegative↗ source
  • Advocacy group Public Citizen petitions FDA to ban direct-to-consumer prescription drug ads
    Public Citizen has filed a petition with the U.S. Food and Drug Administration calling for a ban on direct-to-consumer advertising of prescription medicines. The group argues that such ads are des…
    STAT · 21d agoRegulatoryNegative↗ source
  • Roche stresses careful AI token use and pauses drug from Carmot acquisition
    Roche's CEO Thomas Schinecker said the company is adopting a thoughtful approach to how it employs AI tokens, emphasizing responsible use. He noted that AI tools have already helped increase the n…
    Endpoints · 21d agoNeutral↗ source
  • Verdiva Bio appoints former Metsera CMO Steve Marso as it nears key obesity pill readouts
    Verdiva Bio, a developer of a long-acting oral obesity treatment, announced the appointment of Steve Marso as its chief medical officer. Marso joins from Metsera, a biotech that pursued similar GL…
    Endpoints · 21d agoNeutral↗ source
  • Teladoc expands beyond single-visit model with new service launch
    Teladoc, a pioneer in virtual care, originally built its platform around brief, one-time doctor appointments that could be completed without an in-person visit. The company now says that this sing…
    Endpoints · 21d agoPositive↗ source
  • FDA advisory panel to debate allowing compounding pharmacies to produce unapproved peptides
    FDA advisers will convene on Thursday and Friday to discuss a proposal that would let compounding pharmacies manufacture seven synthetic peptides that are currently classified as unsafe for compoun…
    STAT · 21d agoRegulatoryNegative↗ source
  • J&J gets FDA clearance for general surgery robot; study finds 90% of approved drugs meet post-marketing commitments
    J&J received FDA authorization for a general‑surgery robot, a notable regulatory step for the company. The FDA is also being urged to ban direct‑to‑consumer drug advertisements, highlighting ongoi…
    raps · 21d agoRegulatoryNeutral↗ source
  • EMA seeks input on draft revisions to biosimilar efficacy guidance
    The European Medicines Agency has issued a draft concept paper and is asking stakeholders for feedback on proposed revisions to its guideline for biosimilar efficacy studies. The changes are inten…
    raps · 21d agoRegulatoryNeutral↗ source
  • FDA advisory panel votes to add two peptides, BPC-157 and KPV, to 503A bulk compounding list
    The FDA’s advisory committee voted 8-6, with one abstention, to recommend that two peptides be placed on the 503A Bulks List for bulk compounding. The recommendation covers BPC-157, proposed for ul…
    raps · 21d agoRegulatoryNeutral↗ source