FDA Updates Sarepta’s Duchenne Gene Therapy Label, Requests Postmarketing Study
The FDA has revised the label for Sarepta’s Duchenne muscular dystrophy gene therapy, Elevidys, introducing…
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FDA Initiates Closed-Door Negotiations on Generic Drug User Fees
The FDA and generic drug manufacturers commenced closed-door negotiations last month regarding the fourth round…
Pfizer Closes $10 Billion Metsera Deal
Pfizer has finalized its acquisition of Metsera for $10 billion, a strategic move aimed at…
FDA’s Office of Generic Drugs Ensures Access to Quality Generics
The FDA’s Office of Generic Drugs (OGD) plays a critical role in maintaining the integrity…
AI Meets Genetic Agency at Dyno GATC 2025
BOSTON – Artificial intelligence (AI) emerged as a pivotal theme at the recent Genetic Agency…
UK Considers Raising NICE Cost-Effectiveness Threshold Amidst Drug Spending Debate
The UK is contemplating an increase in the National Institute for Health and Care Excellence…
Bristol Myers, J&J’s new blood thinner fails first big test
Milvexian’s failure in acute coronary syndrome trials has raised significant concerns regarding the future of…
Advocates decry intersex exceptions in trans health bans
Recent legislative measures aimed at restricting transgender healthcare have sparked significant backlash, particularly concerning the…
Bristol Myers, J&J’s Next-Gen Blood Thinner Fails Key Trial in Another Setback for Factor XI
In a significant blow to the pharmaceutical industry’s efforts to develop safer anticoagulants, Bristol Myers…
Pfizer Reduces Stake in BioNTech; Candel Pauses Pancreatic Cancer Program
Pfizer has reduced its stake in BioNTech, now holding approximately $163.5 million in shares following…