Tag Archive for: FDA

Following the regulator’s request for more data beyond the scope of its Phase III TIDES trial, Takeda decided to voluntarily withdraw the Biologics License Application for its TAK-003 dengue vaccine.

The U.S. health regulator said it had received reports of pediatric and adult patients suffering burn injuries when the tools, sold under the brand names MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes, were used on them.

After its Biologics License Application was rejected twice by the FDA, BrainStorm’s Phase III data suggest its amyotrophic lateral sclerosis candidate significantly lowers neurofilament light chain levels.

Yesterday Leqembi won a coveted standard approval nod from the U.S. Food and Drug Administration, the first Alzheimer’s treatment to achieve that goal, clearing the way for wider insurance coverage of the drug. The agency’s decision marks a new milestone for a fatal disease that has eluded drugmakers’ efforts for decades.

Citing insufficient safety evidence for one of the drug’s main ingredients, the regulator in a Complete Response Letter rejected the company’s application for Parkinson’s disease candidate IPX203.

The initiatives coincide with an increase in the volume of data submitted to CDER and CBER—particularly in cell and gene therapy.

Lantidra (donislecel), developed by Chicago-based CellTrans, is a pancreatic islet cell therapy made from the pancreatic cells of deceased donors. It is authorized for adults with type 1 diabetes (T1D) whose repeated episodes of low blood sugar (hypoglycemia) leave them unable to hit average blood glucose levels.

The first half of 2023 saw some milestone FDA approvals, including a series of firsts in superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis, Rett Syndrome and Friedreich’s ataxia. The second half of this year could see at least four more—in Alzheimer’s disease, depression, sickle cell disease and advanced melanoma. 

An FDA advisory committee voted Wednesday that Ipsen’s fibrodysplasia ossificans progressive candidate palovarotene was effective and the benefits of the drug outweighed its risks.

Citing issues with a third-party contractor, the FDA rejected Regeneron’s regulatory application for a higher-dose regimen of Eylea, the company’s blockbuster eye injection treatment.