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15 stories matching this filter · ← front page

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STAT825Endpoints630BioPharma Dive241onclive165Fierce Biotech92BioSpace91raps32globenewswire health
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allOncology800Rare Disease361Cardiology319Immunology301Hematology229Pulmonology223Psychiatry & CNS178
  • Alnylam shares tumble nearly 30% after cutting revenue outlook for key amyloidosis drugs
    Alnylam Pharmaceuticals saw its market value drop about 30%, roughly $12 billion, after it lowered its revenue forecast for its leading amyloidosis treatments. The company had previously expected…
    BioPharma Dive · 3h agoEarningsNegative↗ source
  • FDA advisory panel rejects Capricor's Duchenne heart-cell therapy deramiocel
    An FDA advisory committee voted 9-3 to reject Capricor Therapeutics' experimental cell therapy deramiocel for Duchenne-related cardiomyopathy. The panel said the data did not provide substantial ev…
    BioPharma Dive · 1d agoRegulatoryNegative↗ source
28
fda recalls22
fda press21
fda medwatch17
Vaccines163
Pain106
Ophthalmology103
Endocrinology & Metabolism94
Nephrology71
  • Earnings roundup: Biogen’s ‘resiliency,’ AstraZeneca’s growth pitch and GSK’s oncology push
    Better-than-expected sales helped Biogen regain the support of investors, while AstraZeneca and GSK worked to convince Wall Street that they can hit ambitious revenue targets.
    BioPharma Dive · 1d agoEarningsNeutral↗ source
  • Lilly, with new data, to seek FDA approval of obesity drug retatrutide
    The new findings position Lilly to file an application for the highly anticipated medicine, but also leave some questions about the additive benefits a “triple-G” drug has on heart health.
    BioPharma Dive · 7d ago↗ source
  • FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
    The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot.
    fda press · 8d ago↗ source
  • Summit counters PD-1/VEGF skeptics; Celldex drug fails skin disease study
    A new analysis could address some doubts investors have had about ivonescimab, one analyst said. Elsewhere, Gilead and Merck debuted data for a once-weekly HIV tablet and a new pyschedelics competi…
    BioPharma Dive · 8d ago↗ source
  • Crystalys nets $130M more to push gout drug through late-stage tests
    The startup has a broad global development program underway — and the support of more than 20 investment firms — for a treatment that’s approved in many Asian countries but isn’t yet available in t…
    BioPharma Dive · 8d ago↗ source
  • Novartis climbs on upbeat drug sales as key readouts loom
    A return to quarterly sales growth boosted shares higher on Tuesday, though a handful of coming study results will have a bigger impact on the company’s long-term outlook.
    BioPharma Dive · 9d ago↗ source
  • Pain drugmaker Latigo outlines plans to go public
    The Westlake-founded company specializes in non-opioid drugs that target sodium ion channels, and is now adding to what’s already been a busy month for the biotech IPO queue.
    BioPharma Dive · 10d ago↗ source
  • FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
    The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduc…
    fda press · 13d ago↗ source
  • Lilly to buy AtaiBeckley for $2.8B, further validating psychedelics
    The latest in a prolific streak of buyouts by Lilly is the strongest sign yet that large pharmaceutical companies may finally be embracing a long-dismissed field of research.
    BioPharma Dive · 14d ago↗ source
  • Braveheart, Attovia join next wave of biotech IPOs
    The two startups are the third and fourth, respectively, to outline offerings this month and aim to capitalize on momentum that’s already yielded several big-ticket IPOs.
    BioPharma Dive · 15d ago↗ source
  • Q32 bounces back to claim study success for alopecia drug
    Nearly two years after clinical setbacks cratered Q32’s stock price, new results showed hair growth improvements that surpassed investors’ expectations.
    BioPharma Dive · 17d ago↗ source
  • Roche scraps two Ionis-partnered Huntington’s drugs
    The Swiss pharmaceutical giant told patient groups tominersen didn't delay disease progression in one trial, while a study of a second drug was scrapped because of a safety signal in animal testing.
    BioPharma Dive · 21d ago↗ source
  • AstraZeneca, Ionis drug fails big heart disease study in major setback
    Eplontersen’s failure in transthyretin-mediated amyloidosis cardiomyopathy caught Wall Street analysts by surprise and boosted the outlook of rival drugs from Alnylam and BridgeBio Pharma.
    BioPharma Dive · 21d ago↗ source