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27 stories matching this filter · ← front page

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STAT1155Endpoints871BioPharma Dive339BioSpace293Fierce Biotech275onclive165raps104globenewswire health73
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  • Ionis receives FDA approval for Zanvastro, the first treatment for Alexander disease, as Pfizer partners on new ADC program
    The U.S. Food and Drug Administration approved Zanvastro, marking the first approved medicine for the rare and often fatal neurological disorder Alexander disease. Developed by Ionis Pharmaceutical…
    BioPharma Dive · 2d agoApprovalPositive↗ source
  • AbbVie’s dual-acting myeloma drug etentamig meets main Phase 3 goal, showing longer progression-free survival
    AbbVie announced that its bispecific antibody etentamig achieved the primary endpoint in a Phase 3 trial for patients with multiple myeloma who have progressed after two or more prior therapies. Th…
    BioPharma Dive · 2d agoPositive readoutPositive
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fda recalls67
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Infectious Disease436
↗ source
  • Bristol Myers Squibb pauses autoimmune CAR‑T trials after life‑threatening side effects
    Bristol Myers Squibb announced in early June that it is pausing its CAR‑T therapy trials targeting autoimmune diseases after the trials reported life‑threatening side effects. The company informed…
    STAT · 2d agoRegulatoryNegative↗ source
  • FDA approves Priovant's Lisraya (brepocitinib) for rare skin disease dermatomyositis
    The U.S. Food and Drug Administration has cleared the first oral targeted treatment for dermatomyositis, a rare and disabling skin disorder. The medication, brepocitinib, will be sold under the br…
    BioPharma Dive · 9d agoApprovalPositive↗ 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
  • Gilead reports modest sales rise but analysts question future growth beyond HIV drugs
    Gilead's second‑quarter results showed total product revenue of $7.6 billion, up 8% year‑over‑year. The company's two leading HIV treatments, Biktarvy and Descovy, together generated about $5.7 bi…
    BioPharma Dive · 1mo agoEarningsNeutral↗ source
  • Pfizer expands cost-cutting program, targeting $1 billion in new savings through 2029
    Pfizer announced it is expanding a cost-cutting initiative first launched in 2023 to further reduce expenses. The new measures are projected to generate about $1 billion in additional savings by 2…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Pfizer CFO Dave Denton to leave; Denali Therapeutics sells $195 million FDA priority review voucher
    Pfizer announced that its chief financial officer Dave Denton will depart on Aug. 15 to take a role outside the pharmaceutical sector. He has been CFO since May 2022. In the interim, finance chief…
    BioPharma Dive · 2mo agoDealNeutral↗ source
  • Newborn contracts preventable syphilis amid Pfizer emergency penicillin shortage and procedural delays
    In March 2026 a pregnant woman in Gila County, Arizona tested positive for syphilis. Doctors said she needed an injectable penicillin dose at least 30 days before delivery to avoid severe fetal com…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Pfizer fails to provide emergency penicillin donations as Trump administration seeks policy change to curb drugmaker price avoidance
    Pfizer has not complied with a request from state health agencies to donate emergency penicillin, a measure intended to act as a backstop against congenital syphilis. The shortfall underscores ong…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Lilly’s retatrutide data at ADA 2026 underscores its lead in obesity drug market
    The American Diabetes Association’s 2026 meeting highlighted a wave of new weight‑loss drug data as companies vie for a slice of a market dominated by Eli Lilly and Novo Nordisk. Lilly presented r…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Lilly shares safety data on next-gen obesity drug retatrutide; Revolution Medicines reports strong pancreatic cancer results
    Lilly provided new data that detail the safety and tolerability profile of its next-generation obesity therapy, retatrutide. The information adds to the growing body of evidence supporting the drug…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Novo downplays contested obesity drug as rivals report promising cancer combos and Incyte makes $2 billion blood-disease acquisition
    Novo executives said the obesity drug they once fought Pfizer for is less impressive than expected, downplaying its potential. Revolution Medicines and Tango Therapeutics reported a high response…
    STAT · 3mo agoNeutral↗ source
  • Pfizer’s monthly obesity drug berobenatide shows up to 12% weight loss in mid-stage VESPER-3 study
    Detailed data from Pfizer's mid‑stage VESPER-3 trial indicate that the company’s monthly‑dosed obesity candidate, berobenatide, continues to demonstrate weight‑loss potential. The drug, originally…
    STAT · 3mo agoPositive readoutNeutral↗ source
  • Otsuka showcases kidney drug data; Pfizer cuts an AI deal
    Voyxact helped preserve kidney function, but left an opening for competing IgAN drugs from Vera and Vertex. Elsewhere, Takeda’s alliance with Innovent paid early dividends and Axsome warded off gen…
    BioPharma Dive · 3mo agoDealNeutral↗ source
  • Bipartisan House bill would require security review of U.S. biotech investments in China
    A bipartisan group of Representatives introduced legislation on Tuesday that would expand the Committee on Investment and National Security (COINS) Act to cover biotechnology. The bill, called the…
    BioPharma Dive · 3mo agoRegulatoryNeutral↗ source
  • Fulcrum Therapeutics considers sale after FDA blocks sickle cell drug development
    Fulcrum Therapeutics announced it is undertaking a strategic review that could lead to a sale after its lead sickle cell candidate, pociredir, was effectively blocked by the FDA. The agency cited…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • BioNTech and Pfizer present bispecific cancer data at ASCO, FDA chief notes optimism
    At the American Society of Clinical Oncology meeting, BioNTech and Pfizer highlighted early results from bispecific antibody programs aimed at lung cancer. The companies described the data as promi…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Pfizer partners with China's Innovent Biologics on $10 billion cancer drug collaboration
    Pfizer announced a major partnership with Chinese biotech Innovent Biologics, valued at over $10 billion, to develop cancer therapies. The agreement covers up to 12 antibody-based candidates, incl…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Positive data from Bristol Myers in multiple myeloma and Pfizer in lung cancer unveiled at ASCO
    At the American Society of Clinical Oncology (ASCO) meeting, Bristol Myers Squibb presented early-stage results that showed a favorable response in a multiple myeloma trial. The data suggest the in…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Replimune seeks third FDA approval attempt, Pfizer signs China deal, panel backs updated Covid vaccine
    Replimune is pursuing a third attempt to secure FDA approval for its investigational therapy, after two prior submissions did not succeed. Pfizer has entered into a new agreement to expand its pre…
    STAT · 3mo agoNeutral↗ source
  • Allogene announces CEO David Chang will step down
    Allogene Therapeutics disclosed that its chief executive, David Chang, will be leaving the company. The firm indicated that a succession plan is in place, though it did not provide a specific timel…
    STAT · 3mo agoNeutral↗ source
  • Arvinas, Pfizer find new partner for ‘Protac’ breast cancer drug
    A deal with Rigel Pharmaceuticals ends months of uncertainty about the future of Veppanu, a first-of-its-kind, newly approved medicine with a murky financial outlook.
    BioPharma Dive · 3mo ago↗ source
  • Arvinas’ ‘Protac’ breast cancer drug cleared by FDA
    Known as Veppanu, the drug is the first of its kind to get to market. But Arvinas and partner Pfizer are still searching for a new partner to sell it.
    BioPharma Dive · 4mo ago↗ source
  • FDA tests out ‘real-time’ clinical trials; AbbVie closes in on a KRAS biotech
    Through two pioneering studies, Amgen and AstraZeneca will share study data with FDA scientists as it’s accrued. Elsewhere, Lilly inked a gene editing deal and Pfizer reported success for a multipl…
    BioPharma Dive · 4mo ago↗ source