FDA Breakthrough Designation

Ensysce Biosciences Inc (NASDAQ:ENSC) received an FDA Breakthrough Therapy Designation (BTD) for PF614-MPAR, a next-generation opioid. BTD has been granted to fewer than 300 drugs. It is designed to expedite the development and reviewing of drugs intended to treat a serious condition...

The FDA has reportedly approved Thermo Fisher Scientific Inc's (NYSE: TMO) blood test for preeclampsia, which causes pregnancy-related illness and death, to aid in the risk assessment of pregnant women within the next two weeks.  It is the first and only blood-based...

The FDA has granted Breakthrough Therapy Designation (BTD) to SAB Biotherapeutics Inc's (NASDAQ: SABS) SAB-176, an investigational therapy for post-exposure prophylaxis for Type A and Type B influenza illness in high-risk patients, including antiviral resistant strains.  What...

The FDA has granted Breakthrough Therapy designation to IVERIC bio Inc's (NASDAQ: ISEE) avacincaptad pegol (ACP, also known as Zimura), a novel investigational complement C5 inhibitor for geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD).  To...

Relief Therapeutics Holding SA's (OTC: RLFTF) collaborating partner NRx Pharmaceuticals Inc (NASDAQ: NRXP) has announced that the FDA has denied Breakthrough Therapy Designation for aviptadil.  NRx noted that though the designation is not required for drug...

The FDA has granted Breakthrough Device designation to ReWalk Robotics Ltd's (NASDAQ: RWLK) ReBoot device. The ReBoot is a lightweight, battery-powered orthotic exo-suit intended to assist ambulatory functions in individuals with reduced ankle function related to...

Roche Holdings AG's (OTC: RHHBY) gantenerumab antibody received breakthrough therapy designation from the FDA for Alzheimer's disease. Gantenerumab is designed to neutralize beta-amyloid plaques seen as a driver behind brain cell death. The Company said that the U.S....

The FDA has granted a second Breakthrough Device designation to  CytoSorbents Corporation's (NASDAQ: CTSO) DrugSorb-ATR Antithrombotic Removal System.  The designation covers removing the Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban in a...

The FDA has granted Breakthrough Therapy Designation (BTD) to Shanghai Junshi Biosciences Co Ltd - Coherus BioSciences Inc's (NASDAQ: CHRS) toripalimab for recurrent or metastatic nasopharyngeal carcinoma (NPC). NPC is a rare tumor of the head and neck. The...

The FDA has granted Breakthrough Device Designation status to  Hancock Jaffe Laboratories Inc's (NASDAQ: HJLI) VenoValve, the Company's lead product, currently set to begin its U.S. pivotal trial.  The VenoValve, a porcine-based valve, is a potential treatment...

The FDA has granted Breakthrough Therapy Designation (BTD) to Venclexta (venetoclax) combined with azacitidine for the potential treatment of adult patients with myelodysplastic syndromes (MDS). Venclexta is being developed by AbbVie Inc (NYSE: ABBV) and Roche Holdings AG...

NeuroMetrix Inc's (NASDAQ: NURO) Quell device has received Breakthrough Designation from the FDA to treat fibromyalgia symptoms in adults. Fibromyalgia is a common form of chronic pain accompanied by fatigue, sleep, cognitive and mood disturbances.  Quell is a wearable...

The FDA grants Breakthrough Therapy Designation to Valneva SE's (NASDAQ: VALN) single-shot chikungunya vaccine candidate, VLA1553. This new U.S. milestone comes in addition to the FDA Fast Track designation and the European Medicines Agency's PRIME designation, which...

The FDA has granted Breakthrough Therapy designation to Verastem Inc (NASDAQ: VSTM) for the combination of its investigational VS-6766, with defactinib, for recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy...

The FDA has granted Breakthrough Therapy Designation to Amgen Inc's (NASDAQ: AMGN) bemarituzumab for patients with gastric and gastroesophageal (GEJ) adenocarcinoma. The designation covers bemarituzumab as first-line treatment of fibroblast growth factor receptor 2b,...