Kiromic Biopharma Inc. and two former senior officials have settled with the U.S. SEC to resolve charges involving nondisclosure of U.S. FDA clinical holds on two cancer candidates before and after a July 2021 follow-on public offering that raised $40 million the company desperately needed.
In breaking news, Wave Neuroscience LLC received breakthrough device designation from the U.S. FDA for its magnetic electroencephalogram resonance therapy for adjunctive treatment of post-traumatic stress disorder (PTSD), making its technology the first medical device approved to treat the debilitating condition, the company said.
Mica AI Medical Ltd. is looking to transform the early diagnosis of breast cancer with its software which helps radiologists analyze mammograms more effectively. The company recently signed a collaboration and licensing agreement with Baptist Health South Florida in a bid to bring its technology to the U.S. market.
Arovella Therapeutics Ltd. is heading toward the clinic with its lead product, ALA-101, which consists of a chimeric antigen receptor (CAR) targeting CD19 and invariant natural killer T (iNKT) cells.
Movano Inc., dba Movano Health, added some clinical-grade glitz to its Evie ring with a U.S. FDA clearance for the built-in pulse oximeter. Movan’s stock shot up from an all-time low within minutes of the announcement on Dec. 2, as the clearance breathes new life into Movano’s plans to position the ring as a medical device.
A proposed rule to implement the five-year-old Medicaid Services Investment and Accountability Act would expand the U.S. Health and Human Services’ (HHS) permissive exclusion authority to biopharma manufacturers that misclassify outpatient drugs supplied under agreements with federal health care programs.
The U.S. FDA said it is investigating the risk of hematologic malignancies associated with Bluebird Bio Inc.’s Skysona (elivaldogene autotemcel), approved in 2022 as a one-time gene therapy for treating early active cerebral adrenoleukodystrophy in boys, ages 4 to 17.
Following a late-cycle review meeting with the U.S. FDA in September and the agency’s decision to skip the advisory committee meeting, expectations were high heading toward the PDUFA date for Applied Therapeutics Inc.’s priority NDA for govorestat in galactosemia. So the complete response letter issued by the FDA just ahead of the Nov. 28 PDUFA date, citing deficiencies in the clinical application, caught nearly everyone off guard.
Our immune cells are not just “defenders” against deadly viruses and pathogens but also a great balancer for tissue homeostasis. For neurological disorders, understanding the neuro-immune axis could be key to treating previously untreatable conditions such as autism spectrum disorder, according to Jun R. Huh, professor of immunology at Harvard Medical School.
Arovella Therapeutics Ltd. is heading toward the clinic with its lead product, ALA-101, which consists of a chimeric antigen receptor (CAR) targeting CD19 and invariant natural killer T (iNKT) cells.
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