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1,613 stories matching this filter · ← front page

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  • U.S. experts to evaluate if measles elimination status still holds amid rising cases
    Noel T. Brewer, chair of the U.S. National Verification Committee, explains that his group will review the CDC’s annual measles report to decide if the United States continues to meet elimination c…
    STAT · 12h agoNegative↗ source
  • Third time’s the charm for Replimune as melanoma drug earns FDA greenlight
    Replimune’s immunotherapy for advanced melanoma faced a perilous regulatory road with two previous rejections, but the drug—to be marketed as Tudriqev—prevailed with strong support from oncologists…
    BioSpace · 46m ago↗ source
  • Alkeus, an unorthodox eye drug startup, acquired by Tarsus for up to $800M
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Alkeus brought to late-stage testing a Stargardt disease therapy that former executive chairman and Vertex founder Josh Boger once called, “if it works, the most perfect drug I’ve ever seen.”
BioPharma Dive · 3h ago↗ source
  • Moderna’s flu shot crosses FDA finish line, bouncing back from regulatory roadblock
    The FDA in February slapped Moderna’s vaccine with a refusal-to-file letter—though the agency backtracked a few days later and accepted a revised submission for review. An advisory committee in Jun…
    BioSpace · 9h ago↗ source
  • LifeMine raises $263M in mission to improve organ transplant aftercare
    Patients who receive an organ transplant must take difficult immuno-suppressive medicines for the rest of their lives. LifeMine Therapeutics wants to offer a safer alternative.
    BioSpace · 9h ago↗ source
  • Double shot of Vistagen’s anxiety nasal spray can’t beat placebo in ph. 2 trial
    Following a string of clinical setbacks, Vistagen’s nasal spray for social anxiety has now failed to top placebo even when given as a double dose. But just like with prior disappointing readouts, t…
    Fierce Biotech · 10h ago↗ source
  • STAT+: Biotech’s next big bet: A Tenax study of a heart failure treatment
    Tenax Therapeutics will soon report results from a Phase 3 study that is one of the biggest binary biotech stock events remaining in the sector this year.
    STAT · 10h ago↗ source
  • STAT+: A scientist-turned-biotech executive is notching some wins, and enjoying it
    Scientist-turned-biotech executive Greg Verdine is having a very good year.
    STAT · 10h ago↗ source
  • The next treatment-resistant depression paradigm
    In this episode of Denatured, you’ll hear from Hans Eriksson, chief medical officer at FundaMental Pharma and Steve Levine, chief patient officer at Compass Pathways. We explore why treatment-resis…
    BioSpace · 11h ago↗ source
  • Tarsus pays $450M for Alkeus and its phase 3-stage retinal disease drug
    Tarsus Pharmaceuticals is fronting $450 million to acquire Alkeus Pharmaceuticals for its phase 3-stage retinal disease therapy that's being touted as a potential blockbuster.
    Fierce Biotech · 11h ago↗ source
  • PacBio CEO steps down as Q2 loss widens
    PacBio has promoted an internal veteran to CEO after Christian Henry stepped down, tasking the new leader with improving sales, expanding the DNA sequencing company’s clinical reach and cutting costs.
    Fierce Biotech · 11h ago↗ source
  • BioVie’s stock sinks 50% as company uses composite endpoint to make case for Parkinson’s program
    BioVie has hailed phase 2 data as evidence that bezisterim could represent a “meaningful advance” in the treatment of Parkinson’s disease. But the biotech focused on a new composite measure, rather…
    Fierce Biotech · 11h ago↗ source
  • Context scraps bispecific T-cell engager program to extend cash runway deeper into 2027
    Context Therapeutics has stopped development of the bispecific T-cell engager CT-95, freeing up cash to extend its runway beyond readouts on its two priority clinical programs.
    Fierce Biotech · 15h ago↗ source
  • Actimed gets back rights to wasting disease drug, ending $126M deal with Faraday
    Actimed Therapeutics has brought the full rights to its wasting disease drug back in-house, securing “strategic control” over the asset but losing out on a shot at over $120 million in biobucks.
    Fierce Biotech · 16h ago↗ source
  • Braveheart charges past expectations with $382.5M IPO to fund cardio drug from Hengrui
    Braveheart Bio has overcome its own IPO expectations, rallying $382.5 million in an upsized listing to fund its cardiovascular ambitions.
    Fierce Biotech · 16h ago↗ source
  • Second child death reported in Chinese CRISPR trial for Duchenne muscular dystrophy raises safety concerns
    A second child death has been reported from a Chinese CRISPR gene-editing trial aimed at treating Duchenne muscular dystrophy, reviving concerns about the safety and transparency of such studies.…
    STAT · 1d agoRegulatoryNegative↗ source
  • Lilly beats forecasts while Novo Nordisk misses sales and trial targets
    Eli Lilly reported second-quarter revenue of nearly $23 billion, up 48% year-over-year, easily surpassing analysts’ $20.6 billion estimate. The boost came from continued strength of its tirzepatide…
    BioPharma Dive · 1d agoEarningsNeutral↗ source
  • Eli Lilly posts $23 B Q2 revenue, beats forecasts as Foundayo lags behind Novo's oral GLP-1
    Eli Lilly reported second‑quarter revenue of $23 billion, a 48% increase from the prior year and well above analysts' expectations. The strong top‑line helped the company deliver a sizable earnings…
    BioSpace · 1d agoEarningsNeutral↗ source
  • Lilly and FDA clash over retatrutide classification as company nears submission
    Eli Lilly is preparing to file its obesity drug candidate retatrutide for approval while a legal dispute with the FDA over the drug's classification intensifies. The agency has concluded that reta…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • Novo Nordisk reports mixed trial results for CagriSema and ziltivekimab, cites setbacks and seeks bolt-on deals
    Novo Nordisk's chief executive said the company has experienced "a couple of setbacks" after recent trial data. The phase 3 study of ziltivekimab, an IL‑6 ligand antibody, did not show a statistica…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • Victory Medical Center Pharmacy recalls glutathione vials over high endotoxin levels
    Victory Medical Center Pharmacy in Austin announced a voluntary recall of specific lots of its compounded glutathione 200 mg/mL multi‑dose vials. Testing at the pharmacy detected elevated bacteria…
    fda recalls · 23h agoCRLNegative↗ source
  • FDA approves Takeda’s orexin receptor agonist for narcolepsy, opening new drug class
    The FDA has granted approval to Takeda's novel narcolepsy medication, the first orexin receptor agonist to receive clearance. The twice‑daily pill, marketed as Orzeyful, is indicated for narcoleps…
    STAT · 1d agoApprovalPositive↗ source
  • Lilly's Foundayo obesity pill posts $98 million Q2 sales, trails Novo's Wegovy
    Eli Lilly introduced its oral obesity treatment Foundayo after receiving FDA approval in April 2025. The drug entered the market in the second quarter of 2026, marking Lilly's first foray into an o…
    BioSpace · 1d agoNegative readoutNeutral↗ source
  • Attovia Therapeutics raises $289 million in IPO to fund antibody-drug research for skin and inflammatory diseases
    Attovia Therapeutics completed an IPO raising $289 million, selling 17 million shares at $17 each and valuing the company at $767 million. Shares will begin trading on Nasdaq under the ticker ATTO.…
    BioPharma Dive · 1d agoDealPositive↗ source
  • Analysts spot several biotech firms as likely M&A targets amid rising pharma deal activity
    Pharma companies are actively looking for acquisition opportunities, and analysts have identified a handful of biotech firms that could be next in line for buyouts. Recent transactions have center…
    BioSpace · 1d agoDealNeutral↗ source