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88 stories matching this filter · ← front page

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  • FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing
    FDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufac…
    fda press · 1mo ago↗ source
  • 10 clinical trials to watch in the second half of 2026
    The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.
    BioPharma Dive · 1mo ago↗ source
  • La Ceiba Foods Latin Market Inc. Recalls Cottage Cheese Products Because of Possible Health Risk
    June 26, 2026, – La Ceiba Foods Latin Market Inc. is conducting a recall of Requesón Salvadoreño (Salvadoran Cottage Cheese) and Requesón Mexicano (Mexican Cottage Cheese) products marketed under t…
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fda press21
fda medwatch18
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Endocrinology & Metabolism293
Ophthalmology265
Infectious Disease253
Nephrology239
fda recalls · 1mo ago↗ source
  • Opinion: Maternity deserts aren’t accidents. They’re the result of a design flaw
    Shrinking fertility should mean less strain on doctors. But nearly half of U.S. counties lack a practicing obstetrician or gynecologist.
    STAT · 1mo ago↗ source
  • Moderna flu vaccine wins unanimous support from FDA panel
    The endorsement of an advisory committee positions Moderna to complete a dramatic turnaround for a shot the FDA declined to review earlier this year.
    BioPharma Dive · 1mo ago↗ source
  • A new Westlake-backed biotech takes aim at migraines
    Vedana Therapeutics emerged from stealth Wednesday with $46 million to support its mission of developing “anti-PACAP” therapies, an increasingly popular strategy for migraine prevention.
    BioPharma Dive · 1mo ago↗ source
  • Lilly buys non-opioid pain drugmaker 4E
    It’s the latest in a string of deals for Lilly, which has sunk more than $18 billion into acquisitions over the past few years.
    BioPharma Dive · 1mo ago↗ source
  • Lilly buys another pain biotech; FDA sets decision for once-weekly PrEP pill
    Plus, news about Merck, MultiValent Biotherapies, Alvotech, enGene, Mirum, and Adaptive Biotechnologies. 💸 Eli Lilly acquires another pain biotech: The Indianapolis pharma giant has made its 11th…
    Endpoints · 1mo ago↗ source
  • Lilly scores early positive data for new JAK drug
    Acquired through its purchase of Ajax, the drug showed encouraging effects in patients with hard-to-treat myelofibrosis. To analysts, such results could lead to competition for Incyte’s Jakafi.
    BioPharma Dive · 1mo ago↗ source
  • Celiac disease is entering a new era of therapeutic innovation
    For the ~1 in 100 people living with celiac, the burden of disease extends far beyond their plate.
    BioPharma Dive · 1mo ago↗ source
  • FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
    The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an in…
    fda press · 1mo ago↗ source
  • Rapport ‘fully prepared’ to launch seizure drug solo, CEO says
    In a wide-ranging interview, Abe Ceesay detailed how Rapport built an investor syndicate and why the company is confident it can join the ranks of successful, commercial-stage brain drugmakers.
    BioPharma Dive · 1mo ago↗ source
  • HHS responds coolly to paper on alcohol risk
    Soda and liver cancer, scientists conflicted on a new NIH proposal, and more health news from Morning Rounds
    STAT · 1mo ago↗ source
  • Diabetes association leader apologizes for expulsion of members, pledges to rebuild trust
    The American Diabetes Association CEO apologizes to five members kicked out of annual convention for distributing protest literature, launches review of what went awry.
    STAT · 1mo ago↗ source
  • When it’s time to save a limb, novel clinic meets unhoused people where they are
    Unmet vascular needs can lead to limb loss among unhoused patients. An unusual Massachusetts General Hospital program meets patients where they are.
    STAT · 1mo ago↗ source
  • Study data convince Lundbeck to push new migraine drug forward
    A possible alternative to “anti-CGRP” medications, the drug didn’t meet some analysts’ expectations in mid-stage testing but still convinced Lundbeck to pursue further development.
    BioPharma Dive · 1mo ago↗ source
  • Legend surges on early data for ‘in vivo’ lymphoma cell therapy
    Initial findings show that the therapy reduced or eliminated disease signs in all recipients, sparking hopes that the treatment might be competitive with “ex vivo” medicines like Novartis’ Kymriah.
    BioPharma Dive · 1mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about GLP-1 drugs and knees, FDA cell and gene therapy guidance, and more
    Taking weight loss drugs for at least three years could prevent thousands of knee replacements a year, a new study found
    STAT · 1mo ago↗ source
  • Fulcrum exploring a potential sale after FDA sidelined its sickle cell drug
    Fulcrum’s setback is the latest in a series of stumbles for the developers of sickle cell medicines, among them Pfizer, Novartis and Intellia Therapeutics.
    BioPharma Dive · 2mo ago↗ source
  • The hidden history of BPC-157, a favorite MAHA peptide
    A compound named “substance God help me” by its longtime champion could benefit from RFK Jr.'s favorable views on using peptides.
    STAT · 2mo ago↗ source
  • ‘Unprecedented’ Revolution data point to paradigm shift in pancreatic cancer
    Highly anticipated data presented at ASCO confirmed what’s been heralded as a medical breakthrough against a historically tough-to-treat tumor.
    BioPharma Dive · 2mo ago↗ source
  • FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
    Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarr…
    fda press · 2mo ago↗ source
  • A migraine drugmaker heads to the public markets through reverse merger
    Mentari Therapeutics, a spinout from the prolific hub-and-spoke biotech Paragon, is developing two medications it hopes can treat migraines that aren’t well controlled by existing drugs.
    BioPharma Dive · 2mo ago↗ source
  • When should you get a mammogram? Conflicting advice makes it hard to know
    When should you get a mammogram? Conflicting advice makes it hard to know.
    STAT · 2mo ago↗ source
  • Honesty and Humor Provide Hope in Breast Cancer Survivorship: With Sara Nunnery, MD, MSCI; and Annie Bond
    Dr Nunnery and Annie Bond discuss breast cancer survivorship and patient advocacy.
    onclive · 2mo ago↗ source