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  • FDA approves Moderna's mRNA flu vaccine for older adults, first of its kind
    The U.S. Food and Drug Administration has granted approval for Moderna's influenza vaccine designed for older adults. This marks the first licensed flu shot that uses messenger RNA technology. The…
    STAT · 1mo agoApprovalPositive↗ source
  • FDA approves first drug for type 1 narcolepsy and greenlights mRNA flu vaccine; AstraZeneca and BMS deny merger talks
    The U.S. Food and Drug Administration has granted approval for the first therapy specifically targeting type 1 narcolepsy, marking a milestone for patients with this rare sleep disorder. In a sepa…
    raps · 1mo agoApprovalPositive↗ source
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  • CDC appoints Erica Schwartz as director and Moderna secures approval for mRNA flu vaccine
    The U.S. Centers for Disease Control and Prevention announced that Erica Schwartz has been confirmed as its director, filling a vacancy that has lasted nearly a year. In a separate regulatory upda…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Tenax Therapeutics to Release Phase 3 Heart Failure Trial Results Soon
    Tenax Therapeutics announced that it will soon disclose data from its Phase 3 trial of a heart-failure treatment. The study is being watched as one of the largest binary events left for biotech st…
    STAT · 1mo agoNeutral↗ source
  • AI’s role in medicine isn’t monolithic, says industry leader, urging nuanced adoption
    Priya Abani, CEO of health‑tech firm AliveCor, argues that asking whether AI is good for medicine is a question with an obvious answer: it is. She says the debate has become redundant and that the…
    STAT · 1mo agoPositive↗ 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 · 1mo agoDealPositive↗ source
  • FDA says MDUFA VI will prioritize review consistency and domestic focus over faster timelines
    FDA officials explained that the next Medical Device User Fee Amendments, known as MDUFA VI, will aim to improve consistency in the review process. The agency said the new framework will emphasize…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Medline recalls Hudson RCI neonatal heated wire breathing circuits over connector overheating risk
    Medline Industries announced a nationwide recall of its Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits. The recall was triggered after the company received reports of sporadic failures i…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Experts call for independent 9/11‑style commission to review U.S. Covid response
    In an opinion piece, IDSA President Ronald Nahass argues that the United States should create a nonpartisan, 9/11 Commission‑style body to examine the Covid‑19 response. He says such an inquiry wou…
    STAT · 1mo agoNeutral↗ source
  • EMA launches consultation to streamline nonclinical development for life-threatening diseases
    EMA announced a public consultation on proposals to accelerate the nonclinical phase of drug development for diseases that are severely debilitating or life‑threatening. The agency aims to reduce…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Medicare advances ACCESS pilot but leaves patients unaware of participating providers
    STAT's Health Tech newsletter reports that Medicare is promoting its ACCESS chronic‑care pilot, yet patients cannot see which providers are offering the program. A one‑month progress check highlig…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • US moves to shut Kentucky organ donation nonprofit over safety failures
    The U.S. Health Secretary announced that the federal government will begin the process to decertify Network for Hope, a Kentucky-based organ procurement organization, after allegations of safety la…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Senate committee votes to hold Dr. Fauci in contempt over Covid testimony
    A Senate committee voted along party lines to hold former health official Dr. Anthony Fauci in contempt of Congress after he refused to answer questions about his role in the Covid 19 pandemic resp…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Biotech leader Greg Verdine enjoys a successful year with multiple wins
    Greg Verdine, a scientist who moved into biotech leadership, is reported to be having a very good year. According to the source, Verdine has notched several wins in his role, though the specifics…
    STAT · 1mo agoPositive↗ source
  • 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 · 1mo agoNegative↗ 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 · 1mo 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 · 1mo agoEarningsNeutral↗ 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 · 1mo agoApprovalPositive↗ 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 · 1mo agoDealPositive↗ 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 medwatch · 1mo agoCRLNegative↗ source
  • Erica Schwartz confirmed as CDC director, ending year-long vacancy
    Erica Schwartz was confirmed on Wednesday as the director of the Centers for Disease Control and Prevention, ending a vacancy that lasted almost a year. The Senate approved her appointment by a 51-…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Medicare GUARD pilot faces biotech push to spare rare disease drugs as Moderna begins first-in-human Ebola vaccine trial
    The Medicare Part D GUARD pilot, designed to lower retail drug prices, is under scrutiny because excluding rare disease medicines would erase most of the projected savings, according to STAT. Biot…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Expedition Therapeutics secures $115M Series B to advance China-origin COPD drug
    Expedition Therapeutics, a biotech that licenses drugs from Chinese firms, announced a $115 million Series B financing that will fund mid-stage testing of its experimental COPD candidate. The fund…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Only one third of US prostate cancer patients received pre-biopsy MRI in 2022, far below Western norms
    MRI is considered the standard pre-biopsy imaging tool for prostate cancer in most western nations, yet a new analysis shows that only about a third of US cases used it in 2022. In the United Stat…
    STAT · 1mo agoNegative↗ source
  • Excluding orphan drugs from Medicare pricing pilots could erase most savings, analysis shows
    A Harvard researcher has calculated that removing rare disease treatments from two Medicare pilot programs-GLOBE and GUARD-would dramatically cut the projected cost savings. The pilots are designe…
    STAT · 1mo agoRegulatoryNeutral↗ source