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933 stories matching this filter · ← front page

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  • 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…
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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
  • 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
  • Sanofi halts development of troubled immune drug in eczema
    <figure><div><img src="https://imgproxy.divecdn.com/FBR1IQNmU9Hqatva496Zg2G8JMHsqV0UGsf4LMARqYo/g:nowe:189:144/c:1776:1003/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS80OTY5MDc4Mzc…
    BioPharma Dive · 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
  • 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
  • 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
  • Novo escalates legal fight with Lilly; J&J reinforces ‘dominance’ in multiple myeloma
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    BioPharma Dive · 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
  • Michael Ehlers joins Formation Bio to lead R&D; Black Diamond co-founder dies at 67
    Michael Ehlers left his CEO role at Ascidian Therapeutics, the exon editing company he co-founded, to run R&D at the AI biotech Formation Bio. It’s not often that biotech executives leave ...
    Endpoints · 4d ago↗ source
  • Sanofi nixes Kymab-originated OX40L antibody in atopic dermatitis
    Sanofi has decided to stop working on a drug for eczema it had hoped would be a successor to its immunological megablockbuster Dupixent. The French pharma said that it won’t seek ...
    Endpoints · 4d ago↗ source
  • Merck stages expanded access to monthly HIV PrEP pill ahead of approval
    Following in the footsteps of Gilead, Merck has signed voluntary licensing agreements to enable access to its investigational HIV PrEP pill alimatravir ahead of any regulatory submissions.
    Fierce Biotech · 4d ago↗ source
  • Sanofi abandons plan to seek approval for eczema drug from $1.1B Kymab buyout
    Sanofi has abandoned plans to seek approval for amlitelimab in atopic dermatitis, admitting that a drug once tipped as a potential blockbuster “would not represent a meaningful improvement” to exis…
    Fierce Biotech · 4d ago↗ source
  • Gene editor Scribe starts second-half IPO spree with $129M listing
    A nine-year-old biotech co-founded by CRISPR pioneer Jennifer Doudna is kicking off a run of biotech IPOs set for this year's second half. Scribe Therapeutics priced its $128.7 million
    Endpoints · 4d ago↗ source
  • Scribe secures $129M in a rare gene editing IPO
    <figure><div><img src="https://imgproxy.divecdn.com/v0D5Ajbuzjf7G4SQRuR5yVFGXoGWXxkevKZwUQRcJjs/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMTU2MTc2MTM5LmpwZ…
    BioPharma Dive · 4d ago↗ source
  • Scribe records upsized $129M IPO to bankroll lipid-lowering genetic meds
    In vivo gene editing outfit Scribe Therapeutics has priced its IPO at $128.7 million, surpassing the $96 million goal set out earlier this week.
    Fierce Biotech · 4d ago↗ source
  • FDA panel endorses broader use of certain peptides
    <figure><div><img src="https://imgproxy.divecdn.com/d2JyuXgmLsPVrlZlLVlPLECICsiII5W1r34tQBQf49c/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMjI3NzEwNTIwX0w2O…
    BioPharma Dive · 4d ago↗ source
  • This Week at FDA: Diamantas touts onshoring efforts, grants for DHTs, and more
    <p>Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This…
    raps · 4d ago↗ source
  • FDA advisory committee backs two more peptides, rejects one for compounding list
    <p>By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration (FDA) voted in favor of adding six of the seven peptides it was task…
    raps · 4d ago↗ source
  • Updated: FDA adcomm backs popular wellness peptides, despite staff concerns
    An FDA advisory committee voted to recommend expanding access to popular peptides used by health and wellness enthusiasts for repairing muscles, healing injuries, boosting metabolism and reducing i…
    Endpoints · 4d ago↗ source