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367 stories matching this filter · ← front page

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  • FDA permits Zyn nicotine pouches to be marketed as safer than cigarettes
    The U.S. Food and Drug Administration announced that Zyn's nicotine pouches can be advertised as a safer alternative to traditional cigarettes. The decision reflects the agency's view that the pouc…
    STAT · 2mo agoRegulatoryPositive↗ source
  • FDA approves Tregzi, first T‑reg cell therapy to lower chronic GVHD risk in blood‑cancer transplants
    The FDA announced approval of Tregzi, a regulatory T‑cell based immunotherapy designed to improve chronic graft‑versus‑host disease‑free survival for adults with blood cancers undergoing allogeneic…
    fda press · 2mo agoApprovalPositive↗ source
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fda recalls62
fda press38
Ophthalmology491
Pain468
Endocrinology & Metabolism465
Infectious Disease437
  • Uganda reports Marburg cases, adding to regional Ebola crisis
    Uganda has informed the World Health Organization of a Marburg virus outbreak in its western region, confirming at least one case, with some sources indicating two cases. The emergence of Marburg,…
    STAT · 2mo agoNegative↗ source
  • FDA gene and cell therapy review office loses acting director Vijay Kumar
    Vijay Kumar has announced he will step down from his role as acting director of the Office of Gene and Cell Therapy Reviews within the FDA's Center for Biologics Evaluation and Research. Karim Mik…
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
  • Half of U.S. states file lawsuits challenging Medicaid work-requirement rules
    A coalition of states has filed legal challenges against recent Medicaid work‑requirement policies, arguing that the rules threaten access to health coverage for low‑income residents. The lawsuits…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Trump administration downplays alcohol risks, hindering efforts to curb drinking-related harms
    A STAT investigation reported that the Trump administration has downplayed the health risks of alcohol and has taken steps that obstruct research into drinking-related harms. Although alcohol is r…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Biotech sector eyes key clinical trial readouts in H2 2026 across cancer, Alzheimer’s and autoimmune diseases
    The first half of 2026 saw a surge in biotech activity, with record‑high deal flow, several large IPOs and a regulatory environment that appears to be stabilising after a period of uncertainty. An…
    BioPharma Dive · 2mo agoNeutral↗ source
  • FDA picks seven firms for PreCheck pilot to boost U.S. drug manufacturing
    The FDA announced on June 29, 2026 that seven companies have been chosen for its PreCheck Pilot Program, an initiative aimed at strengthening U.S. drug manufacturing and supply chain resilience. T…
    fda press · 2mo agoRegulatoryPositive↗ source
  • FDA proposes rule to require foreign tobacco makers to register and list products, aiming to curb illegal imports and protect youth
    The U.S. Food and Drug Administration announced on June 26, 2026 a proposed rule intended to strengthen its ability to identify illegal foreign tobacco products, including youth‑appealing e‑cigaret…
    fda press · 2mo agoRegulatoryPositive↗ source
  • FDA advisory panel backs Moderna's experimental flu vaccine in adults 50-64, supports accelerated review for 65+
    The FDA's advisory committee voted unanimously to recommend Moderna's mRNA-1010 flu vaccine for adults aged 50 to 64, and also found it beneficial for those 65 and older. The 9-0 vote allows Moder…
    BioPharma Dive · 2mo agoRegulatoryPositive↗ source
  • Ebola outbreak in Congo and Uganda surges 38% in a week, death toll exceeds 200
    The Africa CDC reported that the Ebola outbreak affecting eastern Congo and Uganda has now resulted in more than 200 deaths within its first month. Confirmed cases have risen to 894 across 32 heal…
    STAT · 2mo agoNegative↗ source
  • FDA advisory panel backs Moderna seasonal mRNA flu vaccine after earlier controversy
    A Food and Drug Administration advisory committee unanimously endorsed Moderna’s seasonal mRNA flu vaccine on Thursday, after the product became the focus of controversy earlier this year when a se…
    STAT · 2mo agoRegulatoryPositive↗ source
  • FDA advisory panel unanimously backs Moderna’s flu vaccine
    The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend Moderna’s seasonal influenza vaccine. The vote overturns earlier hesitations from previous agen…
    Endpoints · 2mo agoRegulatoryPositive↗ source
  • Shingles vaccine linked to 24% lower dementia risk in nursing home residents, study shows
    A new study of elderly nursing home residents examined the effect of receiving at least one dose of the shingles vaccine Shingrix on dementia incidence over a four year period. The analysis found…
    STAT · 2mo agoPositive readoutPositive↗ source
  • Senate Democrats subpoena HHS for records on Trump-era vaccine policy overhaul
    Senate Democrats have launched an inquiry into the Trump administration’s overhaul of U.S. vaccine policy, asking the Department of Health and Human Services to turn over records by the following w…
    STAT · 2mo agoRegulatoryNegative↗ source
  • AI's rising electricity and water demand poses a public health risk, authors warn
    Two public-health scholars argue that the expanding use of artificial intelligence is creating a hidden strain on essential services such as electricity and water. They note that the massive data c…
    STAT · 2mo agoNegative↗ source
  • Trump administration earmarks $700 million for mental health and addiction programs, experts say funds are existing grants
    The Trump administration announced a $700 million allocation for mental health and addiction initiatives. Health Secretary Robert F. Kennedy Jr. described the money as new investments, but behavio…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • UniQure plans to file Huntington’s disease gene therapy with FDA after leadership shift eases data requirements
    UniQure, a Dutch biotech, announced it will seek FDA approval for its gene therapy targeting Huntington’s disease later this summer. The company said FDA staff indicated that three years of data f…
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
  • VC Julie Grant argues U.S. should not restrict biotech investments in China
    Julie Grant, a venture capitalist, told STAT+ that she opposes any U.S. effort to limit biotech investments in China. She says the biotech sector has become increasingly interdependent over decade…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • FDA approves first generic single-dose baloxavir tablet for flu treatment and prevention
    FDA announced approval of the first generic version of Xofluza (baloxavir marboxil) tablets, a single-dose treatment for acute uncomplicated influenza and prophylaxis for patients five years of age…
    fda press · 2mo agoApprovalPositive↗ source
  • Trump administration moves special-education oversight to Health and Human Services
    The Trump administration announced that responsibility for special education will be transferred from the Department of Education to the Department of Health and Human Services. This change is part…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Eli Lilly to acquire non-opioid pain drug developer 4E Therapeutics, adding MNK inhibitor pipeline
    Eli Lilly announced it will purchase 4E Therapeutics, a biotech focused on non‑opioid pain treatments. The acquisition gives Lilly access to 4E’s experimental pipeline, including MNK inhibitors su…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • FDA approves OTC naloxone nasal spray Rextovy, expanding consumer access to overdose treatment
    The FDA announced approval of a new over-the-counter naloxone nasal spray called Rextovy, delivering 4 mg of naloxone hydrochloride for emergency reversal of opioid overdose. The product can be pu…
    fda press · 2mo agoApprovalPositive↗ source
  • FDA staff raise concerns over data for Moderna’s mFlusiva flu vaccine ahead of advisory panel
    FDA staff have examined the evidence for Moderna's mFlusiva, an mRNA flu vaccine, and highlighted shortcomings in the data submitted to the agency. The Food and Drug Administration will convene an…
    BioPharma Dive · 2mo agoRegulatoryNegative↗ source
  • Eli Lilly acquires another pain biotech, its 11th deal this year, as FDA eyes decision on once‑weekly PrEP pill
    Eli Lilly announced the purchase of an Austin, Texas‑based pain biotechnology company, marking the 11th acquisition the Indianapolis‑based firm has completed in 2026. The deal expands Lilly's portf…
    Endpoints · 2mo agoDealNeutral↗ source