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FDA General

HHS Unveils Initiative to Accelerate U.S. Clinical Trials

HHS unveils a broad, department-wide initiative aimed at speeding clinical research, reducing regulatory barriers, and attracting more clinical trials...

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Human Drugs

Regenxbio Gets FDA Agreement to Refile Gene Therapy BLA

Regenxbio reaches an agreement with FDA on a path toward a potential accelerated approval of Navsunli (clemidsogene lanparvovec-sngl), the first gene ...

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Human Drugs

How Global Regulators Handle Cancer Drugs After FDA First Approval: Study

A new journal article finds substantial differences in how major international regulators evaluate and approve oncology drugs that first receive exped...

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FDA General

Ex-FDA Head Gottlieb Warns on Politicization Threatening Scientific Credibility

Former FDA commissioner Scott Gottlieb urges federal health officials to restore scientific leadership at the agency's medical product centers.

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Human Drugs

Former FDA Drug Chief Questions Future of Priority Voucher Program

Former FDA Office of New Drugs director Peter Stein criticizes the agency's National Priority Voucher program at the DIA Global Annual Meeting in Phil...

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Human Drugs

FDA Regulatory Pathway Needed for Dementia Vaccine Trials: Opinion

An opinion article calls on FDA to establish a formal regulatory framework for evaluating vaccines as potential interventions to prevent dementia, arg...

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Human Drugs

Merck Wins Expanded Indication for Pneumococcal Vaccine

Merck says FDA has approved an expanded indication for its pneumococcal conjugate vaccine, Capvaxive, allowing its use in children and adolescents age...

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Biologics

Beam Gets OK to Begin Clinical Testing of PKU Gene-Editing Therapy

FDA approves a Beam Therapeutics IND for BEAM-304, allowing the company to begin clinical testing of its experimental base-editing treatment for pheny...

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Human Drugs

FDA Approves 1st Generic Version of Flu Drug Xofluza

FDA approves the first generic version of Xofluza (baloxavir marboxil), clearing Norwich Pharmaceuticals' generic tablets for the treatment and preven...

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Biologics

Committee Backs Moderna Flu Vaccine

The FDA Vaccines and Related Biological Products Advisory Committee votes to support Moderns mRNA flu vaccine mFlusiva.