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Alzheimer’s disease
Sanofi’s Neuro Push Arrives in Seoul With $1B+ Alzheimer’s Play
The star of the agreement, ADEL-Y01, targets a specific type of tau protein, helping to prevent toxic accumulation in the brain while also preserving the function of healthy tau.
December 16, 2025
·
1 min read
·
Tristan Manalac
Rare diseases
Kyverna’s CAR T Therapy Delivers ‘Impressive’ Mobility Benefits in Stiff Person Syndrome
Kyverna plans to submit mivocabtagene autoleucel to the FDA for approval in the first half of 2026. If approved, it would be the first CAR T therapy for an autoimmune disease.
December 16, 2025
·
2 min read
·
Tristan Manalac
Approvals
AstraZeneca, Daiichi Sankyo Move Enhertu to First-Line Metastatic Breast Cancer
Analysts at Jefferies called the approval “highly significant,” estimating it could add $2 billion to $3 billion to peak Enhertu sales.
December 16, 2025
·
2 min read
·
Tristan Manalac
Venture capital
Ambros Launches With $125M To Bring Italian Non-Opioid Pain Drug to America
Ambros Therapeutics’ non-opioid bisphosphonate analgesic, already approved in Italy, will soon begin a pivotal test in the U.S.
December 16, 2025
·
1 min read
·
Annalee Armstrong
FDA
J&J Wins Proactive FDA National Priority Voucher for Multiple Myeloma Combo
Johnson & Johnson, which did not apply for the national priority voucher, was granted the ticket based on results from a Phase III study testing Tecvayli plus Darzalex in patients with relapsed or refractory multiple myeloma.
December 16, 2025
·
2 min read
·
Tristan Manalac
Press Releases
Zephyrus Innovations™ announces US FDA 510(k) clearance for VaporShield™ CSTD
December 16, 2025
·
2 min read
Press Releases
TreeFrog Therapeutics Announces Changes to Executive Committee With the Arrival of Mark Rothera as Chief Executive Officer & Board Member to Spearhead Next Phase of Growth
December 16, 2025
·
2 min read
Press Releases
RoslinCT and Ayrmid Ltd. Announce Expansion of Strategic Partnership to Manufacture Omisirge® (omidubicel-onlv) for Second FDA-Approved Indication in Severe Aplastic Anemia (SAA)
December 16, 2025
·
3 min read
Press Releases
Calluna Pharma Announces the Appointment of Gijs van den Brink, MD, PhD, as Independent Director
December 16, 2025
·
2 min read
Press Releases
Bicycle Therapeutics Establishes Multiple Strategic Partnerships to Create End-to-End Supply Chain to Support its Wholly Owned Radiopharmaceutical Pipeline
December 16, 2025
·
7 min read
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