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Human Drugs

Share All Cancer Drug Approval Data: Study

Researchers in the U.S. and Australia call for an update to transparency policies so that all individual participant data supporting oncology drug reg...

Human Drugs

FDA Accepts ImmunityBio BLA

FDA sets 5/23/23 as the target PDUFA action date for its review of ImmunityBios N-803 to treat some bladder cancers.

Human Drugs

Lexicon Re-files NDA for Heart Failure Drug

FDA accepts for review a Lexicon Pharmaceuticals NDA resubmission for sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor for treating he...

Human Drugs

Cannabis Administration and Opportunity Act

Senate leaders introduce the Cannabis Administration and Opportunity Act.

Human Drugs

Breakthrough Designation for Vertex Pain Drug

FDA grants breakthrough therapy designation to Vertex VX-548 for some acute and neuropathic pain indications.

Human Drugs

Objectionable Conditions in Goodman Eye Center Trial

FDA warns Dr. Daniel Goodman about objectionable conditions in a clinical trial at his San Francisco, CA-based Goodman Eye Center.

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Human Drugs

Neonatal Study Pharmacology Considerations

FDA publishes a guidance to help drug sponsors who are planning to conduct clinical studies in neonatal populations.

Medical Devices

Guide on LASIK Patient Labeling Recommendations

FDA issues a draft guidance to help ensure that information is available to patients and health care professionals to clearly communicate the benefits...

Federal Register

Ivax Pharmas Chloramphenicol Withdrawn Over Safety

Federal Register notice: FDA withdraws the approval of Ivax Pharmaceuticals ANDA for chloramphenicol capsules (250 mg) after the company requested the...

Federal Register

Info Collection on Pharma Consensus Standards

Federal Register notice: FDA sends to OMB a new information collection entitled Pharmaceutical Voluntary Consensus Standard Recognition.