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  • FDA approves Takeda’s orexin-2 drug Orzeyful for narcolepsy type 1
    The U.S. Food and Drug Administration has approved Takeda Pharmaceutical's new sleep medication, Orzeyful, marking the first product in the emerging orexin‑2 drug class. Orzeyful works by amplifyi…
    BioPharma Dive · 5h agoApprovalPositive↗ source
  • Takeda receives FDA approval for Orzeyful, first orexin agonist to treat all symptoms of narcolepsy type 1
    Takeda announced that the U.S. Food and Drug Administration has approved its drug oveporexton, which will be marketed under the name Orzeyful, for the treatment of narcolepsy type 1 in adults. The…
    BioSpace · 8h agoApprovalPositive↗ source
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Pain274
  • FDA approves Moderna's first mRNA flu vaccine for adults 50 and older
    The Food and Drug Administration has granted approval to Moderna's mRNA flu vaccine, called mFlusiva and previously known as mRNA-1010, making it the first preventive flu shot built on messenger RN…
    BioPharma Dive · 10h agoApprovalPositive↗ source
  • Erica Schwartz confirmed as CDC director after year-long leadership void
    Senate confirmed Erica Schwartz, a public-health veteran and vaccine supporter, as the new head of the CDC. She takes over an agency that has operated without a permanent director for almost a yea…
    BioPharma Dive · 6h agoNeutral↗ source
  • LifeMine secures $263M to advance fungal-derived organ transplant drug
    LifeMine Therapeutics announced it has closed two venture financings that together raised $263 million. The capital will be used to push its experimental therapy, LIFE-001, further along the develo…
    BioPharma Dive · 8h agoDealPositive↗ source
  • Braveheart Bio targets $382 million IPO to fund cardiac drug development
    Braveheart Bio announced an upsized initial public offering on the Nasdaq, aiming to raise about $382.5 million. The company will sell 21.2 million shares at $18 each under the ticker BRVE. The pr…
    BioSpace · 6h agoDealPositive↗ source
  • Sanofi pauses Phase 2 bronchiectasis study of SAR445399 amid new CEO’s portfolio review
    Sanofi has halted a Phase 2 trial of its investigational antibody SAR445399 in non‑cystic fibrosis bronchiectasis. The pause was attributed to strategic business reasons linked to an internal portf…
    BioSpace · 8h agoRegulatoryNeutral↗ source
  • Cardiac biotech Braveheart raises $382.5M in IPO, launches on Nasdaq as BRVE
    Braveheart Bio, a cardiac drug developer, priced its initial public offering on Wednesday and secured $382.5 million in proceeds. The company sold about 21.2 million shares at $18 each, exceeding t…
    BioPharma Dive · 21h agoDealPositive↗ source
  • BioVie shares plunge as Parkinson’s trial results lack primary motor data
    BioVie reported results of its Phase 2 SUNRISE-PD study in early‑stage Parkinson’s disease. The double‑blind, placebo‑controlled trial enrolled 57 patients who had not yet received carbidopa/levodo…
    BioSpace · 2h agoNegative readoutNegative↗ source
  • Choosing Between CROs and Biotechs: How Company Size Shapes the Fit
    While biotechs and contract research organizations each have strengths, the article notes that the right choice depends on a company’s specific situation. Ali Pashazadeh, founder and CEO of Treehi…
    BioSpace · 14h agoNeutral↗ source
  • BioSpace lists top 12 biopharma employers hiring in July 2026
    BioSpace released a list of the twelve biopharma firms with the most job postings in July 2026. The list includes AbbVie, Regeneron, Amgen, Eli Lilly, Sanofi, Novo Nordisk, Moderna, Insmed, Freder…
    BioSpace · 14h agoNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 7h agoLayoffsNegative↗ 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 · 45m ago↗ source
  • Alkeus, an unorthodox eye drug startup, acquired by Tarsus for up to $800M
    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
  • 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
  • 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