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  • White House reviews FDA's new prescription drug user fee agreement for 2028-2032
    The White House is currently reviewing a recently negotiated agreement between the FDA and the biopharma industry that determines the level of prescription-drug user fees for the period 2028 throug…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Eli Lilly stops disclosing Phase 1 pipeline, making early-stage projects invisible in earnings decks
    Eli Lilly has become more opaque as its size grows, choosing to stop public disclosure of its early-stage research efforts. The shift was noted earlier this year when the company removed Phase 1 pr…
    Endpoints · 3mo agoNegative↗ source
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  • Replimune to file third FDA application for RP1 cancer therapy after productive talks
    Replimune announced it will submit a third marketing application for its experimental cancer therapy RP1, following what the company described as productive discussions with the Food and Drug Admin…
    BioPharma Dive · 3mo agoApprovalPositive↗ source
  • AstraZeneca explores options after anselamimab fails Phase 3, while Imfinzi and Tremfya receive label expansions
    AstraZeneca announced that its experimental monoclonal antibody anselamimab failed to meet the primary endpoint in two Phase 3 trials for a specific patient group. The company said it will explore…
    Endpoints · 3mo agoNegative readoutNeutral↗ source
  • Agios halts development of tebapivat for low-risk MDS after disappointing Phase 2b data
    Agios Pharmaceuticals announced it will discontinue development of its pyruvate kinase activator tebapivat for patients with low-risk myelodysplastic syndromes (MDS). The decision follows the relea…
    Endpoints · 3mo agoNegative↗ source
  • Allogene CEO David Chang to step down as Agios drug misses mid-stage trial results
    Allogene announced that its chief executive, co‑founder David Chang, will leave the role after an eight‑year tenure. Chang, who previously worked at Kite Pharma, will remain on the company’s board…
    BioPharma Dive · 3mo agoNegative readoutNeutral↗ source
  • Former FDA official says leadership turnover won’t derail push for faster US drug trials
    The Food and Drug Administration has faced a wave of leadership changes this year, creating uncertainty about its ability to keep drug development moving quickly. Industry leaders and regulators, h…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ source
  • Allogene CEO David Chang to step down after eight years; former Esperion chief joins Phlow
    Longtime Allogene chief executive David Chang announced he will leave the role at the end of June, concluding an eight‑year tenure leading the cell‑therapy developer. The company said a successor…
    Endpoints · 3mo agoNeutral↗ source
  • Replimune to resubmit melanoma therapy RP1 to FDA after two prior rejections
    Replimune announced on Friday that it will again submit its advanced melanoma candidate, RP1, to the U.S. Food and Drug Administration for review. The company says the filing follows new discussion…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • GSK and Ionis report functional cure in 20% of hepatitis B patients with bepirovirsen in early trials
    GSK and Ionis disclosed results from two clinical studies of their RNA‑based injection, bepirovirsen, aimed at achieving a functional cure for chronic hepatitis B. In both trials about one‑fifth o…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • GSK reports strong Phase 3 results for Ionis-licensed chronic hepatitis B therapy
    GSK disclosed data from two late‑stage trials of a chronic hepatitis B treatment it licensed from Ionis Pharmaceuticals. The studies evaluated the drug’s efficacy and safety in patients with chroni…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Eli Lilly's obesity drugs Foundayo and Zepbound added to CVS Caremark formulary
    Eli Lilly announced that its two flagship obesity treatments, the oral agent Foundayo and the injectable Zepbound, will be listed on CVS Caremark's drug formularies. The inclusion comes as the GLP…
    Endpoints · 3mo agoRegulatoryPositive↗ source
  • CVS adds Lilly’s Foundayo and Zepbound to formularies, leveling GLP-1 market with Novo
    CVS Caremark announced it will place Eli Lilly’s new oral GLP-1 drug Foundayo on its formulary starting June 1 and will restore the injectable Zepbound as a preferred option from Oct 1. The change…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • AbbVie receives FDA approval for ultra-rare blood cancer ADC acquired from ImmunoGen
    AbbVie announced that the U.S. Food and Drug Administration has granted approval for an antibody-drug conjugate targeting an ultra-rare, aggressive form of blood cancer. The therapy was obtained t…
    Endpoints · 3mo agoApprovalPositive↗ source
  • Signos secures $20 million to advance GLP-1-focused wearable platform amid broader wearables interest
    The article notes that two wearable‑related developments are being discussed, and both involve GLP‑1 therapies. Signos announced it has raised $20 million to fund its approach that combines wearab…
    Endpoints · 3mo agoDealPositive↗ source
  • ICON audit reveals $65.3M and $92.7M revenue overstatements; Secretome and Psilera announce cash raises
    ICON completed an internal audit that confirmed its reported revenue had been overstated. The audit quantified the overstatement at $65.3 million for 2023, representing about 0.8% of that year's t…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Niowave breaks ground on $75M radioisotope plant in Michigan; CordenPharma to acquire AmbioPharm
    Niowave announced it has started construction of a new radioisotope production facility in Lansing, Michigan, with an investment of about $75 million. The plant will produce radioisotopes used in…
    Endpoints · 3mo agoDealNeutral↗ source
  • Charles River CEO predicts more manufacturers will spin off cell and gene therapy units
    Charles River Laboratories announced three months ago that it would divest its manufacturing unit dedicated to cell and gene therapy production. CEO Birgit Girshick said the company expects it wil…
    Endpoints · 3mo agoNeutral↗ source
  • China gene-editing startup YolTech secures $70 million funding ahead of Hong Kong IPO plans
    YolTech Therapeutics, a Chinese company focused on CRISPR gene-editing therapies, announced it has closed a $70 million financing round, the largest in its history. The capital will be used to adv…
    Endpoints · 3mo agoDealPositive↗ source
  • Oura expands into health services with launch of smaller Ring 5 wearable
    Oura announced the release of its new Ring 5, a smaller version of its popular health‑tracking ring. Alongside the hardware launch, the company said it will add features that let users link their…
    Endpoints · 3mo agoPositive↗ source
  • Former Legend Biotech co‑founder Frank Fan launches new venture at Wondercel Therapeutics
    Frank Fan, a co‑founder of Legend Biotech, moved from Nanjing to Shenzhen in 2022 in search of a fresh start. After leaving Legend abruptly, he assumed the role of chief executive officer at Wonde…
    Endpoints · 3mo agoPositive↗ source
  • FDA delays AstraZeneca breast cancer drug camizestrant PDUFA date
    The U.S. Food and Drug Administration has extended the PDUFA target date for AstraZeneca’s breast cancer candidate camizestrant, pushing the review timeline back by a few days. No new deadline was…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Mentari Therapeutics to go public via reverse merger with InMed, raising $290 million for migraine antibody programs
    Mentari Therapeutics, a spinout of Paragon, announced a reverse merger with InMed Pharmaceuticals that will take the company public under the Mentari name. The deal has received board approval fro…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Acceleron veterans and Westlake back new IPF biotech Oorja Bio with $30 million Series A
    Entrepreneurs who previously brought the drug Winrevair to market have launched a new biotech, Oorja Bio, to target idiopathic pulmonary fibrosis, a hard-to-treat lung disease. The company announc…
    Endpoints · 3mo agoDealPositive↗ source
  • BioMarin's BMN-401 fails key endpoint in ENPP1 deficiency Phase 3 trial
    An experimental therapy, BMN 401, was tested in a Phase 3 study for ENPP1 deficiency, a rare disease. The drug missed one of its two co-primary endpoints, a result that regulators consider critical…
    BioPharma Dive · 3mo agoNegative readoutNegative↗ source