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  • Regenxbio faces second FDA clinical hold, delaying Hunter syndrome gene therapy filing
    Regenxbio announced that its gene therapy for Hunter syndrome has received a second clinical hold from the FDA this year. The company said it no longer expects to submit an NDA or seek approval in…
    Endpoints · 18d agoRegulatoryNegative↗ source
  • Roche commits $190 million upfront to license Hanmi's early-stage muscle-building obesity drug, total deal up to $2.3 billion
    Roche announced it will pay $190 million upfront to license an early-stage obesity drug from South Korean company Hanmi Pharm. The compound is described as a non-incretin, muscle-building therapy a…
    Endpoints · 18d agoDealPositive↗ source
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  • Option-to-acquire structures stay uncommon amid biotech's busy M&A season
    Biotech companies are experiencing one of the busiest deal-making years on record, with a flood of announced mergers and acquisitions. Two recent transactions have highlighted the option-to-acquir…
    Endpoints · 19d agoDealNeutral↗ source
  • Qiagen names Jonathan M. Pratt as new chief executive after nine-month search
    Qiagen announced that Jonathan M. Pratt will take over as chief executive, ending a nine‑month search for a successor. Pratt arrives from Filtration Group, where he served as president and CEO. He…
    Fierce Biotech · 19d agoNeutral↗ source
  • TME Pharma narrows licensing talks for brain-cancer drug NOX-A12, eyes $1 billion market
    TME Pharma, a German biotech, says it has narrowed potential partners for its experimental glioblastoma therapy NOX-A12, a CCL2 inhibitor, to two firms and entered a final evaluation phase. The co…
    Fierce Biotech · 19d agoDealNeutral↗ source
  • Spruce Biosciences advances toward Q4 FDA filing for ultra-rare Sanfilippo B therapy
    Spruce Biosciences reported progress toward filing its enzyme replacement therapy, tralesinidase alfa (TA-ERT), for Sanfilippo syndrome type B, an ultra-rare lysosomal disorder. The company said t…
    Fierce Biotech · 19d agoRegulatoryPositive↗ source
  • FDA pushes back PDUFA date for Capricor's Duchenne therapy to review new data
    The U.S. Food and Drug Administration announced it has extended the PDUFA target date for Capricor Therapeutics' investigational Duchenne muscular dystrophy treatment. The agency said the extensio…
    Endpoints · 18d agoRegulatoryNegative↗ source
  • Bausch + Lomb to launch Phase 3 trial of dry‑eye drop after Phase 2 miss
    Bausch + Lomb announced plans to move its dual‑action dry‑eye drop into a Phase 3 study. The decision follows a Phase 2 trial that did not meet its primary endpoint. CEO Brent Saunders said the r…
    Endpoints · 18d agoNegative readoutNeutral↗ source
  • Cardio firms including AstraZeneca and Novartis to showcase heart drug data at ESC 2026
    At the European Society of Cardiology's annual meeting in 2026, several pharmaceutical companies will present cardiovascular data. The lineup includes AstraZeneca, Ionis, Cytokinetics, Novartis an…
    Endpoints · 18d agoNeutral↗ source
  • Texas lawmaker warns Chinese biotech firms gaining early-stage advantage over U.S. industry
    Rep. Nathaniel Moran, a Republican from Texas and member of the House Select Committee on China, told Fierce that the United States is overlooking how Chinese biotech companies are outpacing Americ…
    Fierce Biotech · 19d agoNeutral↗ source
  • Merck and Moderna report positive topline results for personalized cancer vaccine
    A third death was reported in China’s expedited clinical trials, raising safety concerns for fast‑track studies in the region. Merck and Moderna announced positive topline data from their personal…
    Endpoints · 21d agoPositive readoutPositive↗ source
  • Everything Sprouts recalls alfalfa sprouts over possible E. coli and Salmonella contamination
    Everything Sprouts, LLC, a Minneapolis‑based producer, announced a recall of certain lots of its alfalfa sprouts on August 22, 2026. The recall was triggered because the sprouts may be contaminate…
    fda recalls · 21d agoCRLNegative↗ source
  • Takeda wins FDA nod for orexin drug oveporexton, first treatment for narcolepsy type 1 and potential broader uses
    Takeda received FDA approval for oveporexton (brand Orzeyful), an orexin receptor agonist, marking the first approved therapy that targets the orexin system for narcolepsy type 1. The drug mimics…
    Fierce Biotech · 21d agoApprovalPositive↗ source
  • Genentech pours $750M into new drug‑delivery device plant in Oregon; Bavarian Nordic pushes back Lyme vaccine trial
    Roche’s Genentech announced a $750 million investment to build a new drug‑delivery device manufacturing facility at its Hillsboro, Oregon campus. The plant is intended to expand the company’s capac…
    Endpoints · 21d agoDealNeutral↗ source
  • New study warns that Trump-era cuts to federal research could jeopardize cancer drug development
    A recent study examines how recent political moves to curtail federally funded research could affect cancer drug development. The analysis notes that over the past decade biopharma companies have…
    Endpoints · 21d agoRegulatoryNegative↗ source
  • Replimune appoints former Genentech exec Michelle DiNapoli as chief commercial officer after accelerated melanoma approval
    Replimune announced that Michelle DiNapoli will become its chief commercial officer, starting August 18. DiNapoli previously held senior roles at Genentech, where she led commercial operations. Th…
    Endpoints · 21d agoPositive↗ source
  • Ambros Therapeutics merges with Werewolf, raises $150M to fund phase 3 trial of rare disease drug
    Ambros Therapeutics announced an all‑stock reverse merger with Werewolf Therapeutics, accompanied by a $150 million private placement. The transaction will see the combined company operate under th…
    Fierce Biotech · 22d agoDealPositive↗ source
  • HHS Secretary RFK Jr. seeks to soften U.S. vaccine recommendations
    HHS Secretary Robert F. Kennedy Jr. has issued a request for information seeking to soften government vaccine recommendations. The request, released on Friday, signals that the administration is s…
    Endpoints · 21d agoRegulatoryNegative↗ source
  • GOP lawmakers urge FDA to reject Chinese trial data unless sites undergo recent agency audit
    Two Republican members of the U.S. House have asked the Food and Drug Administration to tighten its oversight of clinical data that originates from China. Their proposal would require the FDA to r…
    Endpoints · 21d agoRegulatoryNegative↗ source
  • Fromm Family Foods recalls over 5,800 cases of wet dog food in US and Canada over possible metal contamination
    Fromm Family Foods LLC announced on August 21, 2026 that it is voluntarily recalling 3,852 cases of its Turkey Pâté Wet dog food and 1,973 cases of its Diner Classics Milo's Meatloaf Pâté Wet dog f…
    fda recalls · 21d agoRegulatoryNegative↗ source
  • California chronic pain biotech co‑founded by Vivek Ramaswamy to go public via reverse merger
    A California biotech company that has developed a chronic pain medication already approved for use in Italy is preparing to list on a U.S. exchange. The firm, co‑founded by entrepreneur Vivek Rama…
    Endpoints · 21d agoDealNeutral↗ source
  • Moderna's cancer vaccine boost lifts stock, sparks talk of Keytruda-like reach
    Moderna’s shares surged 177% after a phase 3 topline win for its Merck‑partnered cancer vaccine, intismeran autogene, was disclosed. The data, released on Wednesday, added roughly $45 billion to Mo…
    Fierce Biotech · 23d agoPositive readoutPositive↗ source
  • FDA clears Vitestro's Aletta, first robotic blood draw device for U.S. clinics
    The U.S. Food and Drug Administration has granted clearance to Vitestro's Aletta, making it the first standalone robotic system approved to draw blood without direct human handling. Aletta can per…
    Fierce Biotech · 23d agoApprovalPositive↗ source
  • Gray‑market copies of Lilly’s obesity drug retatrutide show weaker weight‑loss results, study finds
    A recent study examined the effectiveness of gray‑market versions of Eli Lilly’s triple‑agonist obesity drug retatrutide. The analysis found that patients using these unapproved copies experienced…
    Endpoints · 22d agoNegative readoutNegative↗ source
  • FDA grants approval to Ultragenyx's Genglycos gene therapy for ultra-rare glycogen storage disorder
    Ultragenyx announced that the U.S. Food and Drug Administration has approved its gene therapy called Genglycos. The therapy targets an ultra-rare glycogen storage disorder that can lead to severe…
    Endpoints · 22d agoApprovalPositive↗ source