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936 stories matching this filter · ← front page

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  • Argenx acquires Forte for $2.2B to get hands on phase 2-stage vitiligo drug
    Argenx is spending $2.2 billion to absorb Forte Biosciences for its phase 2-stage vitiligo and celiac disease drug.
    Fierce Biotech · 1d ago↗ source
  • AstraZeneca execs ‘very confident’ in homegrown ADC pipeline despite scrapping 2 candidates
    AstraZeneca executives told Fierce they are “very confident” in the pharma’s in-house pipeline of ADCs despite scrapping two candidates that underperformed in the clinic.
    Fierce Biotech · 1d ago↗ source
  • Lilly, AbbVie climb aboard in vivo CAR T train—but safety remains a hurdle
    Safety will be the key determinant of in vivo CAR T therapies, according to H.C. Wainwright’s Mitchel Kapoor, who noted that convenience and efficacy won’t be enough to impress investors in this sp…
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Hematology6
Pulmonology5
Infectious Disease4
Ophthalmology3
Dermatology2
BioSpace · 1d ago
↗ source
  • Summit, Merck must navigate new regulatory terrain in China-first cancer landscape
    Summit Therapeutics revealed positive Western data last week from a Phase 3 trial of lung cancer candidate ivonescimab. In a flipped geographical clinical trials landscape, what more will be requir…
    BioSpace · 1d ago↗ source
  • FDA has recommitted to adcomms—but to what end?
    The FDA will hold advisory committee meetings this week for previously rejected investigational therapies from Replimune and Capricor Therapeutics. Some industry leaders were surprised the meetings…
    BioSpace · 1d ago↗ source
  • Labcorp launches DTC ‘Genetic Health Panel’ to seek out multiple diseases
    Labcorp is launching the Marker by Labcorp Genetic Health Panel, a new direct-to-consumer genetic testing tool that analyzes 163 genes to determine patients’ risk of over 100 hereditary health cond…
    Fierce Biotech · 1d ago↗ source
  • Recon: WHO releases first interim list of medical device authorities; AstraZeneca using AI to hedge late-stage risks
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 1d ago↗ source
  • Researchers find similar drug development to reimbursement timelines for major markets
    <p>Time between a drug’s entry into clinical trials and its approval for reimbursement was similar in four major markets, according to a cross-sectional analysis published in JAMA Health Forum.</p>
    raps · 1d ago↗ source
  • EMA says it takes ultimate responsibility for protecting online meeting registration, survey information
    <p>The European Medicines Agency (EMA) has issued notices stating how it will comply with certain stakeholder information protection under the Data Protection Regulation for EU institutions, bodies…
    raps · 1d ago↗ source
  • FDA finalizes three guidances to broaden cancer clinical trial eligibility
    <p>The US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has finalized a trio of guidance documents to promote greater participation and diversity in oncology clinical trial…
    raps · 1d ago↗ source
  • Asia-Pacific Roundup: TGA adopts 23 international scientific guidelines
    <p>Australia’s Therapeutic Goods Administration (TGA) recently announced that it has adopted 23 international scientific guidelines from European Medicines Agency (EMA), the International Council f…
    raps · 1d ago↗ source
  • Amgen lays off around 40 employees
    Follow along as BioSpace tracks job cuts and restructuring initiatives.
    BioSpace · 1d ago↗ source
  • Anthropic’s life science plans; Novartis CEO on China deals; and more
    Welcome back to Endpoints Weekly! We’re gearing up for a busy week of earnings coverage, as Moderna, AstraZeneca, GSK, Bristol Myers Squibb and more are set to report their Q2 results. In the meant…
    Endpoints · 3d ago↗ source
  • Amgen shares new Tavneos analysis in effort to resolve FDA dispute
    Amgen shared a new analysis with the FDA that the company said supports keeping its controversial rare disease drug Tavneos on the market. The submission, made Thursday, includes an independent r…
    Endpoints · 3d ago↗ source
  • Amgen sheds around 40 staffers amid continuing struggles
    Amgen has laid off around 40 employees as part of “organizational changes” meant to better align operations with the company’s strategic objectives, Fierce has learned.
    Fierce Biotech · 4d ago↗ source
  • Ipsen’s Bylvay fails key trial in children with rare liver disease
    Ipsen disclosed that Bylvay failed a Phase 3 study for biliary atresia, a serious liver disease that leads the bile ducts to become blocked in babies. Babies with the disease can get a Kasai proc…
    Endpoints · 4d ago↗ source
  • Sanofi’s $1.4B Kymab bet falters again as atopic dermatitis trials scrapped
    Sanofi had hoped the acquisition of Kymab would fill a major hole that will be left as autoimmune juggernaut Dupixent heads toward a patent cliff. Now, another therapy has failed to meet expectations.
    BioSpace · 4d ago↗ source
  • Scribe reels in nearly $129M in rare early-stage IPO for a gene editing biotech
    Jennifer Doudna–founded Scribe Therapeutics intends to use the proceeds from the public offering—the first for a gene editing outfit in over two years—to support development of its epigenetic silen…
    BioSpace · 4d ago↗ source
  • Biogen’s Alzheimer’s data spur excitement, confusion about tau-targeting drugs
    LONDON — One of the most anticipated Alzheimer’s studies in the past few years has created both enthusiasm and confusion, according to conversations Endpoints News recently had with about 20 scient…
    Endpoints · 4d ago↗ source
  • Amgen deploys patients to defend troubled Tavneos in FDA hearing request
    Facing pressure around the world to withdraw the rare kidney disease drug Tavneos, Amgen has launched a robust defense with real-world evidence to support the product’s benefit-risk profile.
    BioSpace · 4d ago↗ source
  • Novo asks court to block Lilly ads; Merck strikes HIV PrEP deal
    Plus news about Abbvie and Genmab, Johnson & Johnson and Mannkind. Novo urges court to block Lilly’s GLP-1 ads: Novo Nordisk asked a New Jersey federal court on Friday to temporarily block wh…
    Endpoints · 4d ago↗ source
  • CHMP recommends Minoryx’s ALD drug, rejects Zevra’s Meplyffa
    Minoryx Therapeutics finally scored backing from EU regulators for its neurological drug that’s faced multiple hurdles. Meanwhile, Zevra’s rare disease drug got a setback in Europe almost two years…
    Endpoints · 4d ago↗ source
  • Study of Yescarta patients reveals genetic red flags for CAR-T therapy side effects
    A new analysis of patients who took part in clinical trials for Kite Pharma’s CAR-T cell therapy Yescarta has revealed genetic signatures of toxicity risk, potentially providing a path forward for…
    Fierce Biotech · 4d ago↗ source
  • Lilly’s $3.8B psychedelics bet won’t open the M&A floodgates
    Eli Lilly’s $3.8 billion play for AtaiBeckley has fueled speculation that Big Pharma is ready to embrace psychedelics. But while the acquisition does validate the drug class, analysts say it is unl…
    BioSpace · 4d ago↗ source
  • Summit has less than a year of cash runway left as PD-1/VEGF verdict nears
    Summit’s star asset is the PD-1/VEGF bispecific ivonescimab, which this week produced promising survival data from a late-stage global trial in non-small cell lung cancer. The FDA review is ongoing…
    BioSpace · 4d ago↗ source