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708 stories matching this filter · ← front page

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  • BMS's Cobenfy faces market hurdles as side effects limit uptake, MapLight eyes opportunity
    The FDA approved Bristol Myers Squibb's Cobenfy in 2024, marking the first novel schizophrenia treatment in 35 years and raising hopes for a new therapeutic approach. Since its launch, the drug ha…
    BioSpace · 14d agoNegative↗ source
  • FDA issues warning letters to Indian OTC drugmaker over falsified logbooks and cites GMP lapses at two other firms
    The FDA sent warning letters to an over‑the‑counter drug manufacturer in India after discovering the company had submitted falsified production logbooks. The agency also cited two additional OTC m…
    raps · 14d agoRegulatoryNegative↗ source
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  • FDA issues warning letters to Indian OTC drugmaker for falsified logbooks and to two others for GMP testing lapses
    The U.S. Food and Drug Administration sent a warning letter to an over‑the‑counter drugmaker in India after discovering that the company had submitted falsified logbooks to the agency. In addition…
    raps · 14d agoRegulatoryNegative↗ source
  • Latigo and BlossomHill file Nasdaq IPO plans to fund pain and cancer pipelines
    Latigo Biotherapeutics and BlossomHill Therapeutics, both based in California, have filed applications to list on the Nasdaq Global Select Market. Latigo aims to raise up to $285.2 million to advan…
    BioSpace · 14d agoDealNeutral↗ source
  • Early regulatory operations planning key to submission-ready dossiers
    Regulatory operations are often treated as a final step after all scientific data are compiled, but the article argues they should be integrated from the start of a development program. A dossier…
    BioPharma Dive · 14d agoRegulatoryPositive↗ source
  • India tightens penalties for submitting false regulatory documents
    The Indian government has introduced stricter penalties for applicants who submit misleading, fake, or fabricated documents to regulatory authorities, prohibiting them from making further filing re…
    raps · 14d agoRegulatoryNeutral↗ 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 · 14d agoPositive readoutPositive↗ source
  • Aspo Oyj announces upcoming leadership changes scheduled for August 10, 2026
    Aspo Oyj, a Finnish specialty chemicals company, issued a brief notice indicating that it will implement leadership transactions. The announcement specifies that the changes will take effect on Au…
    globenewswire health · 14d agoNeutral↗ source
  • Aspo Plc reports managers' transactions on August 10, 2026
    Aspo Plc disclosed that its managers executed transactions on August 10, 2026, as recorded in a filing. The filing does not provide details about the nature, size, or parties involved in the trans…
    globenewswire health · 14d agoNeutral↗ source
  • Replimune secures FDA approval for Tudriqev, eyes $1.3 bn peak sales in advanced melanoma
    Replimune announced FDA approval of its therapy Tudriqev for patients with advanced melanoma who have progressed after PD-1 treatment. Analysts at BMO Capital Markets project the drug could genera…
    BioSpace · 17d agoApprovalPositive↗ source
  • Revolution Medicines sees strong demand for pancreatic cancer drug daraxonrasib under compassionate use
    Revolution Medicines reports that more than 2,000 patients have received its pancreatic cancer candidate daraxonrasib through a compassionate use program. The company says the drug has been distri…
    BioPharma Dive · 17d agoPositive↗ source
  • Bristol Myers Squibb expands Nvidia partnership to build most powerful AI supercomputer for drug discovery
    Bristol Myers Squibb announced an expanded partnership with Nvidia that will give it the most powerful and energy-efficient Nvidia infrastructure owned by a life-science company. Nvidia says the p…
    BioPharma Dive · 17d agoDealPositive↗ source
  • Biopharma job postings rise 15% in Q2 as layoffs fall and M&A activity picks up
    The Q2 2026 BioSpace report shows a strengthening biopharma job market, with more openings and fewer layoffs compared with the prior year. Job postings on BioSpace were up 15% year-over-year and 1…
    BioSpace · 17d agoPositive↗ source
  • Intellia identifies HLA allele linked to severe liver enzyme spikes in ATTR gene therapy
    In November 2025, a patient died after receiving Intellia Therapeutics' investigational gene silencer for transthyretin amyloidosis, prompting a safety review of the company’s ATTR gene therapy pro…
    BioSpace · 17d agoRegulatoryNeutral↗ source
  • Latigo Biotherapeutics raises $345.6M in IPO to fund non-opioid pain drug pipeline
    Latigo Biotherapeutics, a Los Angeles-based biotech focused on non-opioid ion-channel-blocking pain therapies, completed an initial public offering on Thursday. The company sold 19.2 million share…
    BioPharma Dive · 17d agoDealPositive↗ source
  • FDA outlines inspection overhaul, proposes IND reforms, and greenlights a disputed cancer therapy
    FDA officials announced a plan to restructure the agency’s inspectional operations, aiming to make inspections more efficient and focused. The proposed changes include consolidating regional office…
    raps · 17d agoRegulatoryNeutral↗ source
  • EMA releases updated guidance on drug shortage prevention plans
    The European Medicines Agency has published a revised guideline aimed at helping marketing authorisation holders develop and keep drug shortage prevention plans for their products. The new guidanc…
    raps · 17d agoRegulatoryNeutral↗ source
  • FDA grants emergency use authorization for CLiK Extra wound spray to prevent New World screwworm in livestock and wildlife
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for CLiK Extra, a dicyclanil topical suspension designed to be applied around wounds. The authorization allows the pr…
    fda press · 17d agoRegulatoryPositive↗ source
  • Vistagen’s anxiety nasal spray fails to outperform placebo in Phase 2 study
    Vistagen reported results of its Phase 2 trial of the investigational nasal spray fasedienol for social anxiety disorder. The study enrolled 61 patients who were randomly assigned to receive a sin…
    BioSpace · 17d agoNegative readoutNegative↗ source
  • Senior staff purchase company shares, filing 16/2026 shows insider buying
    The company released a corporate announcement stating that several senior employees have bought shares of the firm. The filing, identified as 16/2026, does not provide details on the number of sha…
    globenewswire health · 17d agoNeutral↗ source
  • Company issues corporate announcement on senior employee transaction
    The company released a corporate announcement identified as item 18/2026. The notice indicates that a transaction involving a leading employee has taken place. No further details about the nature…
    globenewswire health · 17d agoNeutral↗ source
  • Replimune’s Tudriqev immunotherapy receives FDA accelerated approval for advanced melanoma
    Replimune announced that the FDA granted accelerated approval for its immunotherapy, now branded Tudriqev, in combination with Bristol Myers Squibb’s Opdivo. The decision follows two earlier reject…
    BioSpace · 18d agoApprovalPositive↗ source
  • FDA grants accelerated approval to Tudriqev viral therapy for PD-1-refractory advanced melanoma
    The U.S. Food and Drug Administration has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically engineered oncolytic viral therapy for patients with advanced, tre…
    fda press · 18d agoApprovalPositive↗ source
  • FDA approves Takeda’s orexin-2 drug Orzeyful for narcolepsy type 1
    The U.S. Food and Drug Administration has approved Takeda Pharmaceutical's new sleep medication, Orzeyful, marking the first product in the emerging orexin‑2 drug class. Orzeyful works by amplifyi…
    BioPharma Dive · 18d agoApprovalPositive↗ source
  • Takeda receives FDA approval for Orzeyful, first orexin agonist to treat all symptoms of narcolepsy type 1
    Takeda announced that the U.S. Food and Drug Administration has approved its drug oveporexton, which will be marketed under the name Orzeyful, for the treatment of narcolepsy type 1 in adults. The…
    BioSpace · 18d agoApprovalPositive↗ source