FDA Outlines Manufacturing Concerns with Elevidys at Catalent’s Maryland Site
The FDA has raised significant concerns regarding the manufacturing processes for Elevidys at Catalent’s Maryland…
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BioMarin makes its largest-ever transaction, paying $4.8B for fellow rare disease drugmaker Amicus
BioMarin Pharmaceutical has executed a landmark transaction, acquiring Amicus Therapeutics for $4.8 billion, marking the…
BMS’ Cobenfy TV ad is latest target of FDA untitled letter spree
The FDA has recently issued an untitled letter addressing the direct-to-consumer advertising of Bristol Myers…
Eli Lilly Submits NDA for Oral GLP-1RA Orforglipron, Targeting Obesity Management
Eli Lilly has submitted a new drug application (NDA) to the FDA for orforglipron, an…
FDA’s National Priority Voucher Pilot Program Promises Dramatic Reduction in Review Times
The FDA’s Commissioner’s National Priority Voucher (CNPV) Pilot Program is set to transform the drug…
UK Committee Demands Clarity on Funding for Higher Medicine Prices in US Trade Deal
The head of a UK government committee has called for greater transparency regarding the funding…
Viral sRNA Unlocks Phage Therapy Potential Against Drug-Resistant Bacteria
As antibiotic-resistant infections escalate globally, researchers are increasingly turning to bacteriophages, viruses that specifically target…
OnPoint NYC Celebrates 1,900 Overdose Reversals Amid Federal Scrutiny
OnPoint NYC, the pioneering nonprofit offering supervised drug consumption services in the United States, marked…
CDC awards $1.6 million grant to Danish researchers linked to FDA official
WASHINGTON — The Centers for Disease Control and Prevention has awarded a $1.6 million grant…
Astrocyte Protein CCN1 Identified as Key to Adult Neuroplasticity in Mouse Model
Recent research published in Nature reveals that the astrocyte-secreted protein CCN1 plays a crucial role…