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Fast Track for Glioblastoma Vaccine

[ Price : $8.95]

FDA grants Diakonos Oncology a fast-track designation for the companys dendritic cell vaccine, DOC1021, for use in patients with g...

Hear Danco Mifeprex SCOTUS Appeal: PhRMA

[ Price : $8.95]

PhRMA calls on the Supreme Court to hear a Danco Laboratories/FDA appeal of a 5th Circuit Court of Appeals decision restricting us...

FDA Denies UCB Generic Fintepla Petition

[ Price : $8.95]

FDA denies without comment the specific requests in a UCB petition asking the agency to not approve an Apotex ANDA for generic Fin...

Omeros Discontinues Narsoplimab Development

[ Price : $8.95]

Omeros stops the development of narsoplimab for treating immunoglobulin A nephropathy based on Phase 3 clinical trial data that di...

Skyrizi Better Than Stelara: AbbVie Data

[ Price : $8.95]

AbbVie reports positive results from the head-to-head Phase 3 SEQUENCE study that evaluated the efficacy and safety of its Skyrizi...

Guide on Testing Pharmaceutical Alcohols

[ Price : $8.95]

FDA publishes a final guidance entitled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.

Guidance on Diabetic Foot Infection Drugs

[ Price : $8.95]

FDA posts a draft guidance entitled Diabetic Foot Infections: Developing Drugs for Treatment.

Zofran Not Withdrawn Over Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Sandozs Zofran ODT (ondansetron) orally disintegrating tablets (4mg and 8mg) were not...

Aldeyra Tussles With FDA on NDA Data

[ Price : $8.95]

Aldeyra Therapeutics says it is addressing substantive late review-cycle concerns raised by FDA on the companys NDA for reproxalap...

GE HealthCare Update on Neonatal Incubators

[ Price : $8.95]

An FDA update says GE HealthCare preliminary testing on its newly manufactured neonatal incubators suggests they may have higher l...