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Intellia Rolling BLA for Hereditary Angioedema CRISPR Therapy

[ Price : $8.95]

Intellia Therapeutics starts a rolling BLA submission for its experimental gene-editing therapy lonvoguran ziclumeran, or lonvo-z,...

FDA Cites Sterile Processing, QC at Outsourcing Facility

[ Price : $8.95]

FDA identifies significant deficiencies at BayCare Integrated Service Center, an outsourcing facility in Temple Terrace, FL, follo...

Priority Review for Jazzs Zanidatamab Combo for Gastric Cancer

[ Price : $8.95]

FDA accepts for priority review a Jazz Pharmaceuticals supplemental BLA for Ziihera (zanidatamab-hrii) for use in combination regi...

Judge Dismisses Homeopathy Industry Challenge to FDA Policy Shift

[ Price : $8.95]

A federal judge dismisses a lawsuit brought by homeopathy advocates and a product distributor challenging FDAs decision to tighten...

Political Pressure on Psychedelics May Undermine FDA Approvals: Experts

[ Price : $8.95]

Concerns that political pressure could undermine the U.S. drug approval system intensify this week after a new White House directi...

FDA Announces Moves to Fast-Track Psychedelic Therapies

[ Price : $8.95]

FDA announces several actions aimed at accelerating the development of treatments for serious mental illness, following a recent e...

FDA Broadens Focus to Examine AI Use in Drug Operations: Law Firm

[ Price : $8.95]

A recent FDA Warning Letter signals a broader regulatory focus on how drugmakers use artificial intelligence, according to a new a...

AbbVie Gets Complete Response for Neurotoxin Candidate

[ Price : $8.95]

FDA issues AbbVie a complete response letter for its BLA for trenibotulinumtoxinE, an investigational, fast-acting botulinum toxin...

Incytes Niktimvo Web Site is Misleading: FDA

[ Price : $8.95]

FDA sends an untitled letter to Incyte Corp., warning that portions of the companys consumer-facing Web site for Niktimvo (axatili...

FDA Compliance Office Ramped Up Enforcement in 2025

[ Price : $8.95]

CDER's Office of Compliance releases a new annual report showing that it expanded enforcement and oversight activities in 2025.