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  • Senior FDA official overrides reviewers to grant Replimune accelerated approval for melanoma drug Tudriqev
    FDA's primary review team recommended rejecting Replimune's melanoma therapy Tudriqev, saying the company had not adequately addressed key deficiencies noted in earlier complete response letters.…
    BioSpace · 11d agoRegulatoryNeutral↗ source
  • Biopharma seeks data scientists as U.S. job market projected to grow 35%
    Biopharma companies are ramping up hiring for data scientists as the U.S. Bureau of Labor Statistics forecasts a 35% increase in data science jobs over the next decade. The surge reflects the growi…
    BioSpace · 11d agoNeutral↗ source
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  • Boston Scientific recalls Infinion CX spinal cord stimulator leads over risk of mechanical stress and fracture
    Boston Scientific issued a recall of its Infinion CX spinal cord stimulator leads after identifying a risk of mechanical stress at the anchor site that can cause high impedance readings or lead fra…
    fda medwatch · 11d agoCRLNegative↗ source
  • FDA issues early alert on Draeger VentStar Resus Neo hoses due to crack risk and potential ventilation failure
    The FDA’s Center for Devices and Radiological Health has released an early alert about a potential high risk issue with Draeger’s VentStar Resus Neo breathing circuit hoses. The alert follows a let…
    fda medwatch · 11d agoRegulatoryNegative↗ source
  • FDA grants emergency use authorization for Capstar and generic nitenpyram to prevent and treat New World screwworm in dogs and cats
    The U.S. Food and Drug Administration issued an Emergency Use Authorization for Capstar (nitenpyram) tablets and updated the EUA for the generic Nitenpyram Tablets. Both products are now authorized…
    fda press · 11d agoRegulatoryPositive↗ source
  • FDA advisory panels for Capricor and Replimune highlight need for rare-disease specialist input
    Recent FDA advisory committee meetings reviewing therapies from Capricor Therapeutics and Replimune produced markedly different outcomes, underscoring how the agency’s reliance on specialist input…
    BioSpace · 11d agoRegulatoryNegative↗ source
  • Benelux biotech strength hampered by fragmented investment, experts discuss path to unified corridor
    In a recent episode of BioSpace's "Denatured" podcast, host Jennifer C. Smith-Parker talks with Christina Takke of V-Bio Ventures and Mariette van der Velden‑Roesink of Curie Capital about the biot…
    BioSpace · 11d agoNeutral↗ source
  • BioSpace lists top 12 biopharma employers hiring in July 2026
    BioSpace released a list of the twelve biopharma firms with the most job postings in July 2026. The list includes AbbVie, Regeneron, Amgen, Eli Lilly, Sanofi, Novo Nordisk, Moderna, Insmed, Freder…
    BioSpace · 11d agoNeutral↗ source
  • GE HealthCare updates use instructions for Portrait Mobile monitoring software after FDA safety alert
    GE HealthCare has sent a letter to customers using its Portrait Mobile Monitoring Solution devices, advising updated instructions for certain versions of the Portrait Core Services software. The F…
    fda medwatch · 11d agoCRLNeutral↗ source
  • Novartis and BMS pause CAR‑T trials after patient deaths while Revolution Medicines gains early FDA approval for pancreatic cancer drug
    Novartis has placed several trials of its CAR‑T therapy rapcabtagene autoleucel on hold after three patients receiving the treatment died. Bristol Myers Squibb also voluntarily froze its autoimmun…
    BioSpace · 12d agoRegulatoryNeutral↗ source
  • BMS faces steep risk if milvexian trial fails, could spark mega-cap merger frenzy
    BMS is heading toward a readout for its oral FXIa inhibitor milvexian, a trial that analysts say could be pivotal for the company's future growth. The recent collapse of merger talks with AstraZen…
    BioSpace · 12d agoNegative readoutNegative↗ source
  • FDA to tighten oversight of foreign clinical trial sites as China trial volume soars
    FDA officials wrote an editorial stating that inspection access is not an administrative footnote and announced plans to expand oversight of foreign clinical trial sites. The initiative follows th…
    BioSpace · 11d agoRegulatoryNeutral↗ source
  • Beyond GLP-1s: Companies eye new obesity drug mechanisms as efficacy plateaus
    The obesity drug market continues to expand, with GLP-1 therapies growing from about $5.5 billion in 2023 to over $55 billion projected for 2033. These agents are used for weight loss, diabetes and…
    BioSpace · 12d agoNeutral↗ source
  • Novartis and Bristol Myers pause autoimmune CAR-T trials after serious safety events
    Novartis and Bristol Myers Squibb announced the suspension of several autoimmune CAR‑T studies after encountering serious safety problems. In Novartis' trials, three participants died from a severe…
    BioPharma Dive · 12d agoNegative readoutNegative↗ source
  • UniQure files FDA priority review request for Huntington’s gene therapy AMT-130
    UniQure, a Dutch biotech, announced on Wednesday that it has submitted applications to the U.S. Food and Drug Administration seeking a priority review for its gene therapy AMT-130, which targets th…
    BioPharma Dive · 12d agoRegulatoryNeutral↗ source
  • UniQure submits FDA and UK applications for first Huntington’s disease gene therapy
    UniQure has filed a biologics license application (BLA) with the U.S. FDA and a separate submission with the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its experimental gene…
    BioSpace · 12d agoRegulatoryNeutral↗ source
  • UK regulator suspends new patients from receiving Tavneos (Avacopan Vifor) amid data concerns
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has decided to stop prescribing Tavneos, known locally as Avacopan Vifor, to any new patients. The decision follows the regulator’…
    BioSpace · 12d agoRegulatoryNegative↗ source
  • Medline expands recall of reprocessed electrophysiology and ultrasound catheters due to contamination risk
    Medline Industries has issued an expanded recall that adds new lots of reprocessed electrophysiology and ultrasound catheters after the FDA identified possible residual particulates in the devices.…
    fda medwatch · 12d agoCRLNegative↗ source
  • Teva reports positive mid-stage results for celiac disease antibody, BioMarin settles patent fight with Ascendis
    Teva said its experimental antibody TEV-408 showed statistically significant and clinically meaningful reduction in gluten-induced intestinal damage in a mid-stage trial for celiac disease. The tr…
    BioPharma Dive · 12d agoPositive readoutPositive↗ source
  • Novartis’ BTK inhibitor remibrutinib cuts MS relapse rates in Phase 3, setting up FDA filing
    Novartis reported that its BTK inhibitor remibrutinib, already approved for chronic spontaneous urticaria, lowered annualized relapse rates in two Phase 3 studies of relapsing multiple sclerosis wh…
    BioSpace · 12d agoPositive readoutPositive↗ source
  • Funding announcements can hint at upcoming biotech hiring opportunities
    Funding announcements serve as early signals that a biotech company may soon expand its workforce, giving job seekers a chance to reach out before roles are formally posted. Alex Benjamin, vice pr…
    BioSpace · 12d agoNeutral↗ source
  • Biotech reverse mergers surge 1,600% in Q3, matching number of IPOs in 2026
    Biotech companies are turning to reverse mergers as a faster, less volatile route to the public markets. In the third quarter of 2026, 17 reverse mergers were completed or announced, a 1,600% incre…
    BioSpace · 12d agoDealNeutral↗ source
  • FDA alerts AVID Medical users to correct convenience kits containing recalled sodium chloride ampules
    The Center for Devices and Radiological Health has posted an Early Alert warning that certain AVID Medical convenience kits may contain sodium chloride ampules recalled by Huons Co. AVID Medical h…
    fda medwatch · 12d agoRegulatoryNeutral↗ source
  • Medline issues correction for convenience kits with potentially non-sterile BD ChloraPrep applicators
    Medline has sent a correction notice after the FDA identified that some BD ChloraPrep applicators included in its convenience kits may not be sterile. The agency says the devices could cause tempo…
    fda medwatch · 12d agoCRLNeutral↗ source
  • Alumis' TYK2 inhibitor flunks mid-stage lupus trial, shares drop 55%
    Alumis reported that its experimental TYK2 inhibitor, envudeucitinib, failed to meet any primary or secondary endpoints in a mid-stage study of systemic lupus erythematosus. The company highlighte…
    BioPharma Dive · 13d agoNegative readoutNegative↗ source