Clinical Trials

  • An all-green glass building facade with a logo that reads "MERCK" is displayed on the exterior of the research facility.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    Patient deaths put Merck, Daiichi’s ADC trial on partial hold

    The FDA placed the hold after researchers recorded a “higher than anticipated” incidence of deaths in a study testing “I-DXd” in people with small cell lung cancer.

    By • Dec. 19, 2025
  • A stack of newspapers are seen against a blue background.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    News roundup

    Novo files for CagriSema approval; Merck and Pfizer’s trial win

    Novo Nordisk's application for CagriSema comes at the same time as competitor Eli Lilly's ask for its obesity drug orforglipron. Elsewhere, Merck & Co. and Pfizer succeeded in a bladder cancer study.

    By BioPharma Dive staff • Dec. 19, 2025
  • An illustration of immune cells attacking a tumor. Explore the Trendline➔
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    Trendline

    Oncology's research boom

    More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

    By BioPharma Dive staff
  • The entrance to Galapagos' corporate offices are lit up at dusk.
    Image attribution tooltip
    Courtesy of Galapagos
    Image attribution tooltip

    Galapagos TYK2 drug hits goal in one trial, misses in another

    The Belgian biotech is still on the hunt for partners after reporting that its drug succeeded against an inflammatory skin and muscle disorder but missed in a lupus study.

    By • Dec. 19, 2025
  • Glucagon-like peptide 1 (GLP1, 7-36) molecule The glucagon like peptide-1 receptor has a strong effect on the management of type 2 diabetes mellitus.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    Obesity drugs

    Lilly obesity pill, headed for quick FDA review, hits mark in ‘maintenance’ trial

    Orforglipron helped keep weight down when used after initial therapy with an injectable, a new treatment strategy that could broaden its use in obesity. 

    By • Dec. 18, 2025
  • An illustration of the collapse of a stock price
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Insmed’s ‘win streak’ ends as top drug fails study in chronic nasal condition

    The company’s valuation, which surged past $40 billion this year, fell by almost a fifth on a dimmer outlook for its closely followed lung disease medicine.

    By Kristin Jensen • Dec. 18, 2025
  • A photo of Takeda president of R&D Andy Plump.
    Image attribution tooltip
    Permission granted by Takeda
    Image attribution tooltip

    Takeda says $4B TYK2 drug succeeds in large psoriasis studies

    The results position Takeda, which acquired its therapy in one of the industry’s larger single-drug acquisitions, to challenge Bristol Myers Squibb’s Sotyktu.

    By • Dec. 18, 2025
  • Research worker in a lab
    Image attribution tooltip
    Permission granted by Pfizer
    Image attribution tooltip
    Sponsored by Pfizer

    Developing a path forward in cancer cachexia

    Pfizer scientists have been working to advance understanding of – and potential treatments for – cachexia.

    Dec. 16, 2025
  • A double exposure image of a glass flask in a laboratory with stock market information in the background.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Nektar sees silver lining as autoimmune drug ‘narrowly’ misses in alopecia study

    Despite being unable to declare statistical success, the company claimed its therapy showed enough promise to support moving into late-stage testing. 

    By Kristin Jensen • Dec. 16, 2025
  • Close-up on a scientist using a mobile app on a digital tablet while working at the laboratory
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Argenx falters in effort to expand immune drug’s use

    The company will stop two trials testing its blockbuster therapy Vyvgart in thyroid eye disease after treatment was judged to be ineffective at an interim checkpoint.

    By • Dec. 15, 2025
  • A photo of Sanofi headquarters in Paris, France.
    Image attribution tooltip
    Courtesy of Sanofi
    Image attribution tooltip

    Sanofi MS drug hits two setbacks

    Tolebrutinib, which Sanofi acquired in a $3.7 billion buyout, failed a Phase 3 study in “primary progressive” multiple sclerosis and is facing a delayed U.S. approval decision in another form of the disease.

    By • Dec. 15, 2025
  • A photo of Kyverna Therapeutics the day of its initial public offering on the Nasdaq stock exchange.
    Image attribution tooltip
    Permission granted by Kyverna Therapeutics
    Image attribution tooltip
    Immune reset

    Kyverna to seek first clearance of a CAR-T therapy for autoimmune disease

    The company intends to file a U.S. application in the first half of 2026 following positive study results in a condition called stiff person syndrome that has no approved therapies. 

    By • Dec. 15, 2025
  • Computer, reading and doctor asian woman in hospital at night for healthcare
    Image attribution tooltip
    Marco VDM via Getty Images
    Image attribution tooltip
    Sponsored by Pearson

    How rare-disease teams can fine-tune COAs to bridge meaningful change and measurable progress

    Discover why refining COAs is essential to capturing subtle, meaningful patient change—and how teams can close the sensitivity gap.

    Dec. 15, 2025
  • Recession arrow, Graph showing business decline on led screen
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Arcus cancels work on Gilead-partnered cancer combo after trial setback

    A study using TIGIT and PD-1 drugs for gastrointestinal disease was canceled for “futility” at an early checkpoint, another blow to research on a once-promising target.

    By • Dec. 12, 2025
  • Brain pipette
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    Brain drug revival

    AC Immune posts positive data for Parkinson’s immunotherapy

    Shares of AC Immune rose by double-digits on news that the company, encouraged by new data, now intends to ask drug regulators for feedback to “potentially accelerate” the time to an approval filing. 

    By • Dec. 11, 2025
  • An Eli Lilly logo is seen at the top of a building.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    Obesity drugs

    Lilly’s three-pronged drug puts obesity field ‘on notice’

    Lilly’s closely watched retatrutide spurred as much as 29% weight loss in a Phase 3 study, a finding that is “raising the bar” for future obesity drug competitors, one analyst wrote.

    By Kristin Jensen • Dec. 11, 2025
  • blood cells lab
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Novartis notches another win for drug acquired in MorphoSys deal

    Ianalumab, which has already succeeded in testing against Sjogren’s syndrome, proved impactful in a condition that causes low platelet counts.

    By • Dec. 9, 2025
  • A stack of newspapers are seen against a blue background.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    News roundup

    FDA raises CAR-T approval standards; Novartis bets on an AI startup

    CAR-T cancer therapies now need to succeed in randomized, controlled trials to earn approvals. Elsewhere, a drug from Bristol Myers Squibb and BioNTech proved effective in breast cancer patients.

    By BioPharma Dive staff • Dec. 9, 2025
  • A micrograph of a myeloma neoplasm in a bone marrow biopsy.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    J&J’s ‘remarkable’ Tecvayli data support earlier use in multiple myeloma

    In a step forward for bispecific antibodies, study results presented at ASH suggest a Tecvayli-based combination could have curative potential early in a patient’s disease course.

    By • Dec. 9, 2025
  • A microscopic image of chronic myeloid leukemia cells, magnified 1000 times.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Terns drug shows potential to challenge Novartis’ blockbuster leukemia treatment

    While early, study results presented at ASH show Tern’s drug could surpass Novartis’ Scemblix and “raise the bar in efficacy” for chronic myeloid leukemia medicines, the company’s CEO said.

    By • Dec. 8, 2025
  • A sign with Eli Lilly's logo sits outside of the company's headquarters on March 17, 2024 in Indianapolis.
    Image attribution tooltip
    Scott Olson via Getty Images
    Image attribution tooltip

    At ASH, Lilly makes case to widen Jaypirca use in leukemia, lymphoma

    In a head-to-head trial, Lilly’s drug was as effective as Imbruvica at inducing responses and displayed certain safety advantages that could make it a preferred treatment in early lines of care. 

    By • Dec. 7, 2025
  • The Vertex Pharmaceuticals building in daylight on the Boston Seaport.
    Image attribution tooltip
    Courtesy of Vertex Pharmaceuticals
    Image attribution tooltip

    Vertex CRISPR therapy hits early goal in children with blood disorders

    Casgevy, now a "national priority" drug, helped kids with sickle cell and beta thalassemia, results which may help toward a label expansion and stronger commercial uptake.

    By • Dec. 6, 2025
  • Boxes of COVID-19 vaccines from Pfizer and Moderna sit side by side.
    Image attribution tooltip
    Joe Raedle via Getty Images
    Image attribution tooltip
    Vaccines

    12 former FDA chiefs blast Prasad’s move to toughen vaccine standards

    In an article published in NEJM, nearly all living ex-FDA commissioners lambasted the CBER head’s plans to use a probe into COVID vaccine safety to upend longstanding regulatory protocols.

    By • Dec. 4, 2025
  • Bottles of Bristol Myers Squibb's Cobenfy, a new drug for schizophrenia, are arranged in this photo illustration.
    Image attribution tooltip
    Permission granted by Bristol Myers Squibb
    Image attribution tooltip

    After finding ‘irregularities,’ Bristol Myers to extend key trial of Cobenfy in Alzheimer’s psychosis

    Data from the "ADEPT-2" study, which analysts had hoped would arrive before year's end, are now expected sometime in 2026.

    By • Dec. 3, 2025
  • An illustration of stock market quotes.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Capricor soars on positive results for Duchenne cell therapy

    Shares quadrupled now that the company appears on track to reverse an earlier FDA rejection of what could be the first treatment for heart-related complications of Duchenne.

    By Kristin Jensen • Dec. 3, 2025
  • A drop of liquid is held via a pipette above a row of vials.
    Image attribution tooltip
    deliormanli via Getty Images
    Image attribution tooltip

    Pharvaris’ pill succeeds in late-stage trial for rare swelling disorder

    Phase 3 data could make the Dutch biotech's drug competitive in the increasingly crowded market of hereditary angioedema treatments.

    By • Dec. 3, 2025