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  • FDA proposes removing obesity and diabetes drug ingredients from compounding substances list
    The U.S. Food and Drug Administration has issued a proposal to remove the active ingredients of widely used obesity and diabetes medicines from the list of substances that can be compounded. The ch…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Seaport and Hemab price IPOs as Avalyn soars on Nasdaq debut
    Three biotechnology companies announced the pricing of their initial public offerings between Thursday and Friday, collectively targeting more than $850 million in proceeds. Seaport Therapeutics a…
    Endpoints · 4mo agoDealPositive↗ source
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  • Psychedelic boom risks sidelining people of color despite new federal push and AbbVie's billion-dollar deal
    The piece highlights that psychedelics are being praised for their therapeutic potential but still face scientific uncertainty and political debate. President Trump signed an executive order aimed…
    STAT · 4mo agoDealNegative↗ source
  • Seaport Therapeutics jumps over 20% on Nasdaq debut as former Karuna team outlines CNS research plans
    Seaport Therapeutics began trading on Nasdaq on May 1, 2026, ringing the opening bell. Its shares surged more than 20% on the first day. The company’s leadership, including the CEO and CSO, highli…
    Endpoints · 4mo agoPositive↗ source
  • Samsung Biologics workers launch five-day strike over wage dispute
    On May 1, 2026 union workers at Samsung Biologics began a five-day strike after a rally in April. The walkout is over wage negotiations, with about 95% of the company's union members voting in fav…
    Endpoints · 4mo agoNegative↗ source
  • Cue Biopharma names Shao‑Lee Lin CEO and licenses new allergy asset from Taiwan and China
    Cue Biopharma announced a reboot, bringing in biotech veteran Shao‑Lee Lin as its new chief executive. Lin, founder of Acelyrin, will lead the Boston‑based company as it expands its pipeline. The…
    Endpoints · 4mo agoDealPositive↗ source
  • Amgen files label update for Tavneos as FDA intensifies withdrawal push
    Amgen has submitted a supplemental filing to the FDA to revise the prescribing information for its osteoporosis drug Tavneos. The amendment adds expanded safety warnings as the agency escalates it…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Johnson & Johnson drops two CAR-T lymphoma programs as market competition intensifies
    Johnson & Johnson announced it is discontinuing two CAR-T cell therapy programs aimed at treating B-cell lymphoma. The decision comes as the market for lymphoma treatments has become crowded, with…
    Endpoints · 4mo agoNegative↗ source
  • Boehringer Ingelheim names Christie Bloomquist as SVP of US corporate affairs and head of its Cares Foundation
    Boehringer Ingelheim announced that Christie Bloomquist has been appointed senior vice president of corporate affairs for its U.S. human pharmaceutical business. In addition to overseeing corporat…
    Endpoints · 4mo agoNeutral↗ source
  • FDA drops Casey Means as surgeon general nominee, naming Fox News radiologist Nicole Saphier instead
    FDA withdrew the nomination of Casey Means for surgeon general and appointed Nicole Saphier, a radiologist and Fox News commentator. The switch underscores the administration’s limited sway in the…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Founder launches new biotech to scale personalized medicines after prior venture folded
    Julia Vitarello’s daughter Mila received a custom‑designed therapy for her rare mutation eight years ago, sparking Vitarello’s interest in individualized treatments. Her first company, EveryONE Me…
    STAT · 4mo agoNeutral↗ source
  • Ailux appoints former AstraZeneca executive Maria Belvisi as chief scientific officer
    Ailux announced the hiring of Maria Belvisi as its new chief scientific officer. Belvisi comes from AstraZeneca where she served as senior vice president of research and development for respirator…
    STAT · 4mo agoPositive↗ source
  • US fertility decline sparks debate over policy motives and family support
    The piece highlights growing alarm in the United States about a sustained drop in birth rates, pointing to factors such as costly childcare, unaffordable housing, shaky health‑care access, and the…
    STAT · 4mo agoNegative↗ source
  • FDA finds low levels of PFAS in most U.S. baby formulas, says supply remains largely safe
    The FDA recently tested 312 infant formula samples from 16 brands and released its findings. The agency detected five types of PFAS, with PFOS appearing in about half of the samples, but 95% of th…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Premium subscribers invited to exclusive post-hoc Q1 earnings recap live event
    A live, post‑hoc session will be held for premium subscribers that reviews first‑quarter earnings across the pharmaceutical sector, with a particular focus on the deal activity reported in the call…
    Endpoints · 4mo agoNeutral↗ source
  • Eli Lilly beats forecasts with 56% revenue jump, lifts full-year outlook
    Eli Lilly reported first‑quarter revenue of $19.8 billion, up 56% year over year, and net income of $7.4 billion, or $8.26 a share. Non‑GAAP earnings were $8.55 a share, well above the $6.77 consen…
    BioPharma Dive · 4mo agoEarningsPositive↗ source
  • BMS's Krazati fails confirmatory colorectal cancer trial, jeopardizing its accelerated approval
    Bristol Myers Squibb said its drug Krazati did not meet the primary endpoint in a confirmatory study for second‑line colorectal cancer. The trial was required to verify the benefit that earned the…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • House panel urges FDA to bar Chinese clinical trial data from drug applications
    A House spending committee introduced language urging the FDA to prohibit the use of clinical trial data generated in China when reviewing new drug applications. The proposal reflects concerns abo…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Merck remains optimistic on Terns leukemia drug despite new data
    Merck said Thursday that it still sees a compelling outlook for Terns' leukemia drug even after updated study data suggested it may be less differentiated. The updated data came from a trial of TE…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • UniQure to submit UK marketing application for Huntington's gene therapy AMT-130
    UniQure announced it will file a marketing application in the United Kingdom later this year for its gene therapy AMT-130 aimed at Huntington's disease. The filing follows a positive meeting with…
    BioPharma Dive · 4mo agoRegulatoryPositive↗ source
  • Elevance blocks deposition of former Medicare Advantage chief as DOJ seeks testimony
    Elevance Health told the Justice Department it would not make Peter Haytaian, an outgoing executive who oversaw its Medicare Advantage plans, available for a deposition, the agency said in a letter…
    STAT · 4mo agoRegulatoryNegative↗ source
  • J. Craig Venter, pioneering genomics scientist, dies at 79 after cancer treatment
    J. Craig Venter, a leading figure in genomics, passed away at age 79. The cause was complications from a cancer treatment. Venter’s work helped turn genetics from a craft into an industrial inform…
    STAT · 4mo agoPositive↗ source
  • FDA oncology panel votes against AstraZeneca's camizestrant trial, citing lack of meaningful benefit
    The FDA's oncology advisory committee convened for the first time in about nine months and evaluated AstraZeneca's late-stage trial of its oral selective estrogen receptor degrader, camizestrant.…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Supreme Court hints at ruling in case over generics' use of skinny-label drugs
    Supreme Court justices have offered preliminary signals about how they may decide a contentious lawsuit that could reshape the way generic drug makers market products with "skinny labels". The cas…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • FDA proposes removing semaglutide, tirzepatide, liraglutide from 503B compounding list
    The FDA has proposed removing the active ingredients of several popular GLP‑1 drugs from the 503B compounding list. The agency says there is no clinical need for large compounding facilities to pr…
    STAT · 4mo agoRegulatoryNeutral↗ source