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FDA Meeting to Review Survival Data for Osteosarcoma Therapy

[ Price : $8.95]

FDA grants OS Therapies a Type C statistical methods meeting with CBER to discuss 2.5-year overall survival data for OST-HER2, the...

Replimune Approval Document Highlights Reviewer Objections

[ Price : $8.95]

An FDA approval document shows that the accelerated approval of Replimunes Tudriqev came despite significant concerns about the re...

FDA Warns Aurobindo Pharmas Eugia Unit

[ Price : $8.95]

FDA has issued a warning letter to a Telangana, India, sterile drug manufacturing facility operated by Aurobindo Pharma subsidiary...

Baxter Recalls Duo-Vent Solution Sets Over Air Embolism Risk

[ Price : $8.95]

Baxter is recalling (Class 1) certain lots of its Duo-Vent solution sets because the devices may allow air bubbles to enter the ad...

FDA OKs Lantheus Tau PET Imaging Agent for Alzheimers Disease

[ Price : $8.95]

FDA approves Lantheus Holdings Tauklarify (florquinitau F 18 injection) as a PET imaging agent to identify tau neurofibrillary tan...

Capricor Plans Deramiocel BLA Amendment After FDA Input

[ Price : $8.95]

Capricor Therapeutics plans to amend its BLA for deramiocel to modify its proposed indication after discussions with FDA produced ...

Accelerated Approval for Zenbexus Combo in Multiple Myeloma

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FDA grants Bristol-Myers Squibb accelerated approval for Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-f...

FDA Seeks Injunction Against Steiner Biotechnology

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The Department of Justice seeks an injunction to stop Steiner Biotechnology from manufacturing and marketing adulterated and misbr...

FDA Questions Zynlontas Benefit/Risk: Report

[ Price : $8.95]

FDA is raising questions about the risk/benefit of ADC Therapeutics Zynlonta as a second-line treatment for diffuse large B-cell l...

3 Observations on Reliance Life Sciences FDA-483

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FDA releases the Form FDA-483 issued following an inspection at Indias Reliance Life Sciences drug manufacturing facility in Navi ...