Tag: business
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AbbVie’s Juvmo Wins FDA Approval for Parkinson’s Disease
The FDA approved AbbVie’s Juvmo (tavapadon), a once-daily oral D1/D5 dopamine receptor partial agonist, for adults with Parkinson’s disease. Phase 3 TEMPO data support its efficacy, while pricing, coverage and real-world tolerability remain key commercial questions.
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GRAIL’s Galleri Wins FDA Panel Backing for Multi-Cancer Blood Test
FDA advisers backed GRAIL’s Galleri multi-cancer blood test, but a split effectiveness vote leaves key questions ahead of the final PMA decision.
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Anthropic Opens Wet Lab to Test Claude in Biology Experiments
Anthropic has opened a Bay Area wet lab to test how Claude and the Model Hardware Standard can connect AI reasoning with physical biology experiments.
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Eli Lilly’s Inluriyo–Verzenio Combination Wins FDA Approval in ESR1-Mutated Breast Cancer
The FDA approved Eli Lilly’s Inluriyo plus Verzenio for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after endocrine therapy. In an exploratory EMBER-3 analysis, median progression-free survival was 11.1 months with the combination versus 5.5 months with Inluriyo alone.
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Ultragenyx’s Fayuvi Wins FDA Approval as the First Treatment for Sanfilippo Syndrome Type A
The FDA approved Ultragenyx’s Fayuvi as the first treatment for pediatric MPS IIIA, supported by a 23.5-point cognitive treatment effect.
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Skyhawk’s SKY-0515 Posts 1.59-Point cUHDRS Advantage at 15 Months
Skyhawk’s SKY-0515 showed a 1.59-point cUHDRS advantage over an external control at Month 15, alongside sustained reductions in mutant huntingtin and PMS1 messenger RNA.
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BioNTech’s Gotistobart Posts 18.5-Month Median Survival in Squamous NSCLC
Gotistobart achieved median overall survival of 18.5 months versus 10.0 months with docetaxel in the non-pivotal stage 1 portion of PRESERVE-003.
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GSK Plans First-Line Jideytro Filing After 94% Response Rate
GSK plans to seek first-line FDA approval for Jideytro after the ROS1 inhibitor achieved a 94% response rate in 94 TKI-naïve patients in the ARROS-1 study.
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AbbVie’s Qulipta Meets Phase 3 Goal in Menstrual Migraine
AbbVie’s Qulipta met the Phase 3 LUNA primary endpoint in menstrual migraine, reducing perimenstrual migraine days with a seven-day regimen timed to the onset of menses.
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Scholar Rock’s Isembyld Wins FDA Approval for Spinal Muscular Atrophy
The FDA approved Scholar Rock’s Isembyld for patients aged two years and older receiving SMN2-targeted therapy, adding the first muscle-directed treatment to established SMA care.