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Human Drugs

No IND for American Behavioral Study: FDA

FDA warns Boca Raton, FL-based American Behavioral Research Institute that it did not have an IND for a clinical study of Relaxium.

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Medical Devices

More Comprehensive AI Regulation Needed: Report

U.S. and Canadian AI researchers call on FDA to develop a more comprehensive regulatory framework for AI healthcare tools.

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FDA General

Makary/Prasad Priorities for A New FDA

FDA commissioner Martin Makary and CBER director Vinay Prasad use a JAMA article to list their five priorities for what they call a new FDA.

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Human Drugs

Promising Insmed Data in Pulmonary Arterial Hypertension

Insmed releases positive results from a Phase 2b clinical trial of its once-daily inhaled therapy treprostinil palmitil inhalation powder and its use ...

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FDA General

Former FDA Regulatory Counsel Lands at Alston & Bird

Former FDA regulatory counsel Jessica Ritsick joins Alston & Birds FDA practice in Washington, DC., after an 11-year career at the agency across numer...

Human Drugs

Innoviva NDA for Gonorrhea Antibiotic Accepted by FDA

FDA accepts for review an Innoviva Specialty Therapeutics NDA for zoliflodacin, an investigational first-in-class spiropyrimidinetrione oral antibioti...

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Human Drugs

Can Surprise Foreign Drug Inspections Boost Safety?

A MedShadow online post says President Trumps executive order to increase unannounced foreign drug inspections could help improve domestic drug manufa...

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Human Drugs

FDA Backs Jaguar on Cancer Diarrhea Drug Development

Jaguar Health plans to conduct a pivotal trial of crofelemer for cancer therapy-related diarrhea in breast cancer patients after gaining FDA support.

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Human Drugs

Pheast Gets Fast Track for Ovarian Cancer Drug

As it heads into a Phase 1 study, FDA grants Pheast Therapeutics a fast-track designation for PHST001 and its use in treating patients with advanced p...

FDA General

RFK Jr. Fires 17 CDC Vaccine Committee Members

HHS secretary removes all 17 members of the CDCs Advisory Committee for Immunization Practices (ACIP), and plans to appoint new members in the coming ...