FDA recommends including a boxed warning and other elements in breast implant labeling
A research team from the School of Chinese Medicine at Hong Kong Baptist University (HKBU) has successfully developed a novel aptamer, i.e. a single-stranded piece of DNA, for the treatment of osteogenesis imperfecta (OI) with the aid of artificial intelligence (AI) technology. It is the first time a drug in Hong Kong has been granted orphan drug designation by the US Food and Drug Administration (FDA).
Surface Modifying Macromolecules in Dialyzers and Bloodlines are Paired with Dialysate Formula to Prevent Clots
Flowonix Medical, Inc.announced approval from the United States Food and Drug Administration (FDA) to market the Prometra II® 40 mL Programmable Pump and its associated programmer software.
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The U.S. Food and Drug Administration (FDA) recognizes that consumers may use various types of unapproved drugs, such as homeopathic drug products, to treat or relieve different diseases and conditions.
ARsgen Therapeutics Co. Ltd., a clinical-stage biopharmaceutical company today announced that the United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational CT053 CAR-T cell therapy. CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of relapsed and/or refractory multiple myeloma (rrMM).
SFA Therapeutics, Inc. announced today that FDA has granted an official Orphan Drug Designation (ODD) to SFA001, the company's novel human-microbiome-based treatment for human hepatocellular carcinoma (HCC).
Given proximity of NDA action date to anticipated top-line data readout for Phase 3 VOYAGER trial, FDA requested VOYAGER top-line data to inform its review of fourth-line GIST indicatio
Suntiva, a trusted advisor to leaders in achieving critical business transformation outcomes, is proud to announce that it recently won ten BPA orders with the U.S. Food and Drug Administration (FDA), with a total value of more than $9 million.
Acting commissioner of the U.S. Food and Drug Administration (FDA) Dr. Ned Sharpless recently released a statement regarding medical device availability following the closure of multiple sterilization facilities.
The U.S. Food and Drug Administration's (FDA) acting commissioner, Dr. Ned Sharpless, has released a statement on the agency’s efforts to address the opioid crisis as the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act marked its one year anniversary on Oct. 24.
One of the U.S. Food and Drug Administration's top priorities is to ensure that Americans have access to safe and effective medicines. Sometimes, for a number of reasons, shortages of certain medicines occur and the FDA works immediately with our public health partners and industry to minimize their impact on patients and restore the availability of these drugs.
To conduct in vitro testing of the effects of excipients on oral drug absorption
The U.S. Food and Drug Administration (FDA) issued 13 warning letters in October that were sent to manufacturers and other companies found to have violated FDA regulations.
As FDA deadlines approach for regulations on electronic tobacco products, observers say the industry is in for a period of change and consolidation.
Med-botics, LLC Targets Post-operative Death and Harm from Opioids
Over 60 New Tests of the Recalled Lot Conducted by Two Third-Party Laboratories Find No Asbestos
The U.S. Food and Drug Administration is taking steps towards requiring electronic submission of certain safety reports for products being evaluated by the FDA under an investigational new drug (IND) application into the FDA's Adverse Event Reporting System (FAERS).
AASCP is hosting an FDA Panel and many distinguished physicians this weekend at their annual Scientific Congress. All physicians practicing stem cell treatments should not miss this event on Nov. 1-3, 2019.
LY03004, Luye Pharma's innovative, independently developed Extended-Release Microspheres for Injection has taken another step closer to going on the U.S. market.