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708 stories matching this filter · ← front page

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  • Ultragenyx secures FDA approval for Glenglycos, first gene therapy for GSD Ia
    Ultragenyx announced FDA approval of Glenglycos, a one-time gene therapy for glycogen storage disease type Ia, a rare genetic disorder. The therapy delivers a functional gene to the liver to resto…
    BioPharma Dive · 4d agoApprovalPositive↗ source
  • Ultragenyx secures first gene therapy approval for GSDIa as Sanfilippo asset decision pending
    Ultragenyx received accelerated FDA approval for its gene therapy DTX401, marketed as Genglycos, to treat glycogen storage disease type Ia (GSDIa). The approval comes as the company awaits a secon…
    BioSpace · 4d agoApprovalPositive↗ source
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fda recalls49
fda medwatch45
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923
Psychiatry & CNS741
Ophthalmology432
Pain413
Endocrinology & Metabolism395
Infectious Disease373
  • Biotech firms EMD Serono and Exelixis cut remote R&D staff as they enforce office return policies
    Biopharma workers at two biotech companies are losing jobs as employers shift away from remote work. The changes affect research and development staff who were previously allowed to work from home.…
    BioSpace · 4d agoLayoffsNegative↗ source
  • FDA approves Ultragenyx gene therapy for glycogen storage disorder; Overton faces confirmation hurdles
    The U.S. Food and Drug Administration has granted approval to Ultragenyx's gene therapy aimed at treating a glycogen storage disorder. This marks a regulatory milestone for the company and the rare…
    raps · 4d agoApprovalPositive↗ source
  • Regeneron wins FDA approval for Pasatru, targeting rare bone disease FOP
    The U.S. Food and Drug Administration has approved Regeneron Pharmaceuticals' drug Pasatru for the treatment of fibrodysplasia ossificans progressiva (FOP), a very rare condition in which muscle an…
    BioPharma Dive · 4d agoApprovalPositive↗ source
  • Experts discuss persistent CMV challenges and new antiviral approaches for transplant patients
    In a recent episode of BioSpace's Denatured podcast, Ian McGowan, chief medical officer of Synklino, and James Hunter, an associate professor of transplantation at Oxford University, joined host Je…
    BioSpace · 4d agoNeutral↗ source
  • Pediatric rare cancer research draws steady investment despite biotech market volatility
    The article notes that pediatric rare cancers continue to attract investment because they address the greatest unmet medical needs and allow clear measurement of patient impact. Even as the biotec…
    BioSpace · 4d agoPositive↗ source
  • Experts call for modernizing rare disease evidence models using FDA plausible mechanism framework
    A recent paper in The Journal of Clinical Investigation argues that the evidentiary approach for rare diseases needs updating. The authors suggest applying the FDA’s plausible mechanism framework,…
    raps · 4d agoNeutral↗ source
  • EMA launches consultation on draft framework to speed adoption of data standards
    EMA has opened a public consultation on a draft framework aimed at accelerating the implementation of data standards across the pharmaceutical sector. The agency says the new framework is intended…
    raps · 4d agoRegulatoryNeutral↗ source
  • Moderna shares surge as Merck-Moderna mRNA melanoma vaccine meets Phase 3 endpoint
    Merck and Moderna reported that their personalized mRNA cancer vaccine, combined with Merck’s Keytruda, slowed melanoma recurrence in a Phase 3 study. The interim analysis showed a statistically si…
    BioSpace · 5d agoPositive readoutPositive↗ source
  • Moderna-Merck mRNA cancer vaccine shows landmark interim success in melanoma trial
    An interim analysis of a Phase 3 trial of an individualized mRNA cancer vaccine from Moderna and Merck showed the treatment met its primary goals. The vaccine, given together with Merck's immunothe…
    BioPharma Dive · 5d agoPositive readoutPositive↗ source
  • FDA grants accelerated approval to Genglycos, first therapy for glycogen storage disease type Ia
    The U.S. Food and Drug Administration issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr), marking the first therapy for patients aged eight years and older with glycogen…
    fda press · 4d agoApprovalPositive↗ 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 · 5d agoRegulatoryNeutral↗ source
  • FDA authorizes Aletta, first standalone robotic device for automated blood draws
    The U.S. Food and Drug Administration announced it has authorized Aletta, a robotic system that can draw blood without hands‑on operator involvement. The device is cleared for adult use in outpati…
    fda press · 5d agoRegulatoryPositive↗ source
  • Enveda’s oral obesity pill shows strong GI safety in Phase 1, paving way for trials in patients off GLP-1 drugs
    Enveda reported that its Phase 1 study of the oral obesity candidate ENV-308 demonstrated an exceptional gastrointestinal safety profile in healthy volunteers. The topline data, released on August…
    BioSpace · 5d agoPositive readoutPositive↗ source
  • Takeda’s FDA-approved Orzeyful expands treatment to all narcolepsy symptoms, challenging existing sleep drugs
    The U.S. Food and Drug Administration approved Takeda's drug Orzeyful in August, marking the first therapy that addresses the full spectrum of narcolepsy symptoms, including cataplexy and excessive…
    BioSpace · 5d agoApprovalPositive↗ source
  • Novo Nordisk leads early in oral obesity market, but analysts doubt lasting advantage
    Novo Nordisk's oral formulation of Wegovy generated DKK 3.22 billion (about $496 million) in revenue in the second quarter of 2026, far outpacing Eli Lilly's newly approved oral weight‑loss pill Fo…
    BioSpace · 5d agoNeutral↗ source
  • Trump administration eyes Heidi Overton as next FDA commissioner
    President Donald Trump is reported to be preparing a nomination for Heidi Overton to become the next commissioner of the Food and Drug Administration, according to multiple news outlets. Overton i…
    BioPharma Dive · 5d agoRegulatoryNeutral↗ source
  • Trump nominates White House aide Heidi Overton as FDA commissioner
    President Donald Trump is reported to be selecting Deputy Director of the White House Domestic Policy Council Heidi Overton, a physician, to be the next FDA commissioner, pending Senate confirmatio…
    BioSpace · 5d agoRegulatoryNeutral↗ source
  • Biopharma hiring surges in New Jersey, 11 companies post dozens of new roles
    BioSpace data shows job postings for biopharma positions in New Jersey have risen year over year, with a notable 73% jump in July compared with the same month last year. The upward trend has persi…
    BioSpace · 5d agoPositive↗ source
  • Amylyx reports promising GLP-1 blocker results while Summit faces survival setbacks and Definium shows anxiety therapy benefit
    Amylyx said its investigational GLP-1 blocker avexitide cut the combined rate of level 2 and level 3 hypoglycemic events by about 55% in patients with post‑bariatric hypoglycemia, beating analyst e…
    BioSpace · 5d agoNeutral↗ source
  • LabCentral partners with Hong Kong Science and Technology Parks to link biotech founders across US and China
    LabCentral, a Massachusetts biotech accelerator, signed a memorandum of understanding with Hong Kong Science and Technology Parks Corporation (HKSTP) in June at the BIO International Convention. T…
    BioSpace · 5d agoDealPositive↗ source
  • President Trump nominates White House aide Heidi Overton as FDA Commissioner
    President Donald Trump announced on his Truth Social platform that Heidi Overton, a White House aide, will be nominated to lead the U.S. Food and Drug Administration. Overton is set to replace Mar…
    raps · 5d agoRegulatoryNeutral↗ source
  • BioSpace launches dashboard to track performance of U.S. biotech IPOs in 2026
    BioSpace introduced a new IPO dashboard that monitors U.S. biotech companies that went public in 2026. The tool will be refreshed weekly with the latest closing prices and will add any newly liste…
    BioSpace · 5d agoNeutral↗ source
  • Why Biopharma Executives Should Hire an ‘Implementer’ to Turn Ideas into Action
    Leadership Lab is a new column aimed at biopharma leaders facing real‑world pressures. In the opening piece, Michael Pietrack of Kaye/Bassman International argues that the most valuable hire for an…
    BioSpace · 5d agoPositive↗ source