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Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.
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Heightened diligence standards and longer decision timelines for early-stage startups slowed venture activity last year, J.P. Morgan found in a report published ahead of the bank’s annual healthcare conference in San Francisco.
The prevalence of serious inflammatory safety issues such as cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome limits the reach of these transformative cancer therapies.
After greenlighting 56 novel therapeutics in 2025, four notable applications continue to await the agency’s action after being delayed from the fourth quarter last year.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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The FDA approval of Alnylam’s Amvuttra sets up a three-way race with Pfizer and BridgeBio, which both market transthyretin stabilizers for transthyretin amyloid cardiomyopathy.
Paratek Pharmaceuticals is betting that OptiNose’s chronic rhinosinusitis treatment will be a partner to its antibiotic treatment Nuzyra.
After Sarepta reported the death of a patient who had recently taken the gene therapy Elevidys, patient advocacy group Parent Project Muscular Dystrophy stepped up—as they always do.
The deal is the latest in a series of Sanofi investments in its immunology portfolio. According to Sanfoi, DR-0201 can achieve deep B cell depletion, giving it the potential to reset the immune system.
The Supreme Court last year blocked a previous settlement proposal from Purdue, arguing that the plan would afford the Sackler family too much protection.
A group of medical experts expressed concern about growing “disinformation” and “misinformation,” calling for adherence to recommended vaccine schedules.
Democratic senators from Georgia, Oregon, Maryland and New Mexico called the Trump administration’s decision to terminate hundreds of CDC staffers reckless and unfair.
Learn about making the most of interview feedback, navigating bonus clawbacks and networking for niche roles.
Nearly half of BioSpace poll respondents recently took a biopharma job they were overqualified for, a finding that didn’t surprise a talent acquisition expert, who said it’s become much more likely to happen.
After bringing Zolgensma to market in 2019 as the first gene therapy for spinal muscular atrophy, Novartis is back with an intrathecal formulation intended for older patients.