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Human Drugs

Two-Day Workshop on Oncology Patient Registries

FDAs Oncology Center of Excellence announces a two-day virtual public workshop to advance the development of patient registries in oncology, with a fo...

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Human Drugs

CGMP Violations at Oasis Medical

FDA warns Glendora, CA-based Oasis Medical about CGMP violations in its production of finished drugs.

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FDA General

Laura Loomer Targets Makary Over Prasad Exit

Right-wing commentator Laura Loomer publicly criticizes FDA commissioner Marty Makary over recent comments surrounding the departure and mooted return...

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FDA General

Former FDA Staff Chief Joins Hogan Lowells

Former FDA chief of staff Elizabeth Jungman joins law firm Hogan Lovells as a partner in its pharmaceuticals and biotechnology practice in the Washing...

Human Drugs

Vertex Signal Inhibitor VX-993 Misses Trial Goal

Vertex Pharmaceuticals says it will not pursue its investigational VX-993 as monotherapy for acute pain following bunionectomy surgery due to its fail...

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Human Drugs

Dyne Gets Breakthrough Status for Duchenne Therapy

FDA grants Dyne Therapeutics a breakthrough therapy designation for DYNE-251 for treating patients with Duchenne muscular dystrophy that is amenable t...

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FDA General

TransMedics Gets Heart Trial Conditional Approval

FDA grants TransMedics Group conditional approval to begin its next-generation Organ Care System ENHANCE heart trial.

Medical Devices

Philips Respironics Recalls Ventilators

Philips Respironics recalls (Class 1 device correction) its V30, A30, and A40 ventilators to update their use instructions due to the risk of failure ...

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Human Drugs

Anixa Bio Moving Breast Cancer Vaccine Into Phase 2

Anixa Biosciences assumes full sponsorship of a Cleveland Clinic IND for ian experimental breast cancer vaccine as it heads towards a Phase 2 clinica...

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Biologics

Turmoil Led to Pazdur Overriding BLA Decision: Report

A new report from STAT describes drug review turmoil at FDA that led to FDA Oncology Center of Excellence director Richard Pazdur overriding CBER revi...