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95 stories matching this filter · ← front page

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  • Layoffs hit over 1,300 workers across seven biopharma M&A deals in 2026
    Workforce reductions this year have affected at least seven biopharma companies that recently completed mergers or acquisitions, eliminating a minimum of 1,359 jobs, according to BioSpace data. Th…
    BioSpace · 2d agoLayoffsNegative↗ source
  • Heidi Overton nominated as FDA commissioner, seen as boost for psychedelics and non-opioid pain drugs
    President Donald Trump announced that he will nominate Heidi Overton, a current White House policy advisor, to serve as the next FDA commissioner pending Senate confirmation. Analysts say Overton’…
    BioSpace · 3d agoRegulatoryNeutral↗ source
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73
fda recalls48
fda medwatch41
fda press28
911
Psychiatry & CNS725
Ophthalmology425
Pain406
Endocrinology & Metabolism390
Infectious Disease362
  • How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and Medicine
    As AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, s…
    BioSpace · 5d agoRegulatoryNeutral↗ source
  • Overseas MDMA and psilocybin makers eye U.S. market as regulatory landscape eases
    Companies that produce MDMA and psilocybin for patients abroad are turning their attention to the United States, hoping to leverage experience gained under more permissive foreign rules. Rising pol…
    BioSpace · 8d agoPositive↗ source
  • Definium’s oral LSD candidate DT120 shows strong anxiety reduction in Phase 3 trial
    Definium Therapeutics reported that its single‑dose oral LSD candidate DT120 achieved a statistically significant reduction in anxiety symptoms in a Phase 3 study of generalized anxiety disorder. T…
    BioSpace · 10d agoPositive readoutPositive↗ source
  • Eli Lilly's $3.8 B acquisition of AtaiBeckley signals growing confidence in psychedelics for depression
    Psychedelics are being touted as a potential solution for patients who still struggle to find lasting relief from existing FDA‑approved psychiatric medicines. The article notes that many individual…
    BioSpace · 12d agoDealPositive↗ source
  • Psychedelic firms Definium and Compass poised for key data releases
    Investors and analysts are focusing on two psychedelic companies as they approach pivotal milestones. Definium Therapeutics is set to release Phase 3 Voyage data for its single-dose oral LSD candi…
    BioSpace · 12d agoPositive readoutPositive↗ source
  • Denali Therapeutics' Avlayah generates $3.6M in Q1, beating forecasts
    Denali Therapeutics reported that its newly launched Hunter syndrome therapy Avlayah earned $3.6 million in revenue during the first quarter after its April market entry. Analysts had projected ro…
    BioSpace · 12d agoPositive readoutPositive↗ source
  • Lilly's Foundayo obesity pill posts $98 million Q2 sales, trails Novo's Wegovy
    Eli Lilly introduced its oral obesity treatment Foundayo after receiving FDA approval in April 2025. The drug entered the market in the second quarter of 2026, marking Lilly's first foray into an o…
    BioSpace · 17d agoNegative readoutNeutral↗ source
  • Analysts spot several biotech firms as likely M&A targets amid rising pharma deal activity
    Pharma companies are actively looking for acquisition opportunities, and analysts have identified a handful of biotech firms that could be next in line for buyouts. Recent transactions have center…
    BioSpace · 17d agoDealNeutral↗ source
  • FDA approves Orzeyful, first drug to treat all symptoms of narcolepsy type 1
    The U.S. Food and Drug Administration announced on August 5, 2026 that it has approved Orzeyful (oveporexton) tablets for adults with narcolepsy type 1. Orzeyful is the first therapy cleared to tr…
    fda press · 17d agoApprovalPositive↗ source
  • Supernus and Indivior merge to form CNS-focused company with 11 marketed drugs and $2.2B revenue target
    Supernus Pharmaceuticals and Indivior Pharmaceuticals announced an all‑stock merger of equals, creating a central nervous system‑focused company that will combine their product lines and operations…
    BioSpace · 19d agoDealPositive↗ source
  • Novo Nordisk’s Phase 3 failure of IL-6 drug ziltivekimab rattles inflammation-focused pipeline
    Novo Nordisk reported that its late-stage IL-6 inhibitor ziltivekimab did not achieve its primary goal in the Phase 3 ZEUS trial, which was designed to lower cardiovascular complications. The disa…
    BioSpace · 19d agoNegative readoutNegative↗ source
  • Biopharma job postings in New York rise 34% over past year, seven companies now hiring
    Biopharma employment opportunities in New York appear to be expanding, with job listings on BioSpace increasing 34% between July 2025 and July 2026. Although the number of postings dipped slightly…
    BioSpace · 24d agoNeutral↗ source
  • Otsuka receives FDA approval for Simtriyo, first norepinephrine-dopamine-serotonin reuptake inhibitor for ADHD
    Otsuka Pharmaceutical announced that the FDA has approved its daily pill centanafadine, branded as Simtriyo, for the treatment of attention-deficit hyperactivity disorder in patients six years and…
    BioSpace · 26d agoApprovalPositive↗ source
  • Eli Lilly’s $3.8 billion acquisition of AtaiBeckley signals strong backing for psychedelic therapeutics
    Novartis and Roche kicked off the second‑quarter earnings season, with other majors such as AstraZeneca, GSK and Biogen slated to follow. The earnings wave highlights continued revenue growth acros…
    BioSpace · 1mo agoDealPositive↗ source
  • Eli Lilly’s $3.8 B bid for AtaiBeckley signals strong pharma endorsement of psychedelics
    Eli Lilly has announced a proposed acquisition of AtaiBeckley valued at up to $3.8 billion. Analysts at H.C. Wainwright described the move as the clearest strategic validation to date of psychedeli…
    BioSpace · 1mo agoDealPositive↗ source
  • Eli Lilly to acquire AtaiBeckley in up to $3.8 billion deal, entering psychedelics market
    Eli Lilly announced it will buy AtaiBeckley, offering $6.75 per share for the company’s common stock. The transaction includes an upfront commitment of about $2.8 billion and a contingent value rig…
    BioSpace · 1mo agoDealPositive↗ source
  • Dr Loghavi on the Significance of Updated WHO Diagnostic Criteria for AML in Clinical Practice
    Sanam Loghavi, MD, discusses updated WHO diagnostic criteria for acute myeloid leukemia and its significance for diagnoses and treatment selection.
    onclive · 3mo ago↗ source
  • FDA Approves Decitabine/Cedazuridine Plus Venetoclax in Newly Diagnosed AML
    The FDA has approved oral decitabine/cedazuridine plus venetoclax for newly diagnosed AML unfit for intensive chemo, based on phase 2 ASCERTAIN-V data.
    onclive · 3mo ago↗ source
  • FDA Approves Sonrotoclax for Relapsed/Refractory Mantle Cell Lymphoma
    The FDA granted accelerated approval to sonrotoclax for relapsed/refractory mantle cell lymphoma after at least 2 lines of systemic therapy.
    onclive · 3mo ago↗ source
  • Dr Dinardo on the FDA Approval of Decitabine/Cedazuridine Plus Venetoclax in AML
    Courtney D. DiNardo, MD, MSCE, discusses the FDA approval of decitabine/cedazuridine plus venetoclax in acute myeloid leukemia.
    onclive · 3mo ago↗ source
  • Tirabrutinib and CAR T-Cell Therapy Represent Potential Paradigm Shifts in R/R PCNSL
    Ashley Sumrall, MD, FACP, FASCO, discusses emerging data for tirabrutinib and the evolving role of CAR T-cell therapy in primary central nervous system lymphoma.
    onclive · 3mo ago↗ source
  • Future Directions in Metastatic Castration-Resistant Prostate Cancer
    Dr. Pedro Barata and Dr. Johann De Bono conclude the discussion by reflecting on the evolving future of radiopharmaceutical therapies in metastatic castration-resistant prostate cancer (mCRPC) and…
    onclive · 3mo ago↗ source
  • Personalized Treatment Decision-Making in Metastatic Castration-Resistant Prostate Cancer
    Dr. Johann De Bono and Dr. Pedro Barata discuss the increasing complexity of personalized treatment decision-making in metastatic castration-resistant prostate cancer (mCRPC) as radiopharmaceutical…
    onclive · 3mo ago↗ source