FDA Approves GSK's 5-in-1 Meningococcal Vaccine For Adolescents Ahead Of CDC Advisory Committee Vote Meeting Next Week
GSK's Penmenvy wins FDA approval to protect against five meningococcal serogroups. The CDC panel will vote on usage ...
STAT5d
As officials prepare for WHO-led flu vaccine meeting, many wonder: Will the U.S. show?
Each year, flu experts from around the world gather to map out recommendations for next winter's flu vaccine. This year, it's ...
PMGC submits pre-IND meeting request to FDA for EL-22 in obesity
Northstrive Biosciences has submitted a pre-Investigational New Drug, or pre-IND, meeting request to the FDA for EL-22, a novel myostatin asset ...
Monthly Prescribing Reference10h
Pentavalent Meningococcal Vaccine Penmenvy Gets FDA Approval
Penmenvy combines the antigenic components of Bexsero (meningococcal Group B vaccine) and Menveo (meningococcal Groups A, C, Y, and W-135 oligosaccharide diphtheria CRM197 conjugate vaccine).
Small-Cap OS Therapies Inks Commercial Manufacture Agreements For Lead Cancer Drug For Rare Type Of Bone Cancer
HER2, a HER2-targeted immunotherapy, with plans for FDA submission following promising Phase 2b data in osteosarcoma.
Investing4d
OS Therapies gears up for FDA meeting on cancer drug
As the company prepares for its regulatory meetings, the healthcare community ... OST-HER2 osteosarcoma trial payments and prepare for FDA approval. Additionally, OS Therapies has acquired ...
Yahoo Finance5d
Ryoncil® FDA Approval and Market Launch Highlighted at Tandem Transplantation Meetings
Ryoncil ® was approved in December 2024 by the United States Food and Drug Administration (FDA) for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients 2 months ...
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From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...