JHVEPhoto/iStock Editorial via Getty Images Novo Nordisk (NVO) announced Thursday that the U.S. Food and Drug Administration (FDA) declined to approve its once-weekly insulin product, insulin icodec, targeted at patients with diabetes mellitus (DM). Issuing a complete response letter, the regulator has requested information related to its manufacturing process andContinue Reading
Iryna Drozd Adicet Bio (NASDAQ:ACET) stock jumped 10% Monday morning after the company said it had received FDA fast track designation for its CAR-T cell therapy candidate ADI-270 for the treatment of metastatic/advanced clear cell renal cell carcinoma, a type of kidney cancer. The designation was granted for the treatmentContinue Reading
designer491 Pulse Biosciences (NASDAQ:PLSE) stock rallied 22% in morning trading Monday after the medtech company said it had received FDA breakthrough device designation for its CellFX nanosecond pulse field ablation cardiac surgery system for the treatment of atrial fibrillation, or AFib. Pulse said it plans to pursue a premarket approvalContinue Reading
Waldemarus Roche (OTCQX:RHHBY) unit Genentech announced Friday that the U.S. Food and Drug Administration (FDA) approved a new ready-to-use format for its eye disease therapy Vabysmo to treat three leading causes of vision loss. Accordingly, the bispecific antibody, also known as faricimab, will be available in a new format forContinue Reading
jetcityimage/iStock Editorial via Getty Images The U.S. FDA has approved Eli Lilly’s (NYSE:LLY) donanemab as a treatment for early Alzheimer’s disease. The therapy, which is given via infusion once a month, will be marketed under the name Kisunla. Lilly noted that the treatment will cost $12,522 over six months andContinue Reading
JHVEPhoto Checkpoint Therapeutics (NASDAQ:CKPT) said it has resubmitted its Biologics License Application to the FDA for its antibody treatment cosibelimab for the treatment of cutaneous squamous cell carcinoma, or cSCC. The biotech company said it filed the resubmission after reaching alignment with the FDA regarding deficiencies outlined in a CompleteContinue Reading
jmiks Pacira BioSciences (NASDAQ:PCRX) plummeted ~25% in Tuesday trading after the U.S. FDA approved a generic version of Exparel (bupivacaine liposome), a non-opioid used for post-surgery local anasthesia. The agency approved an abbreviated New Drug Application for a generic version from Hengrui Pharma. Exparel is by far Pacira’s biggest revenueContinue Reading
JHVEPhoto Humacyte (NASDAQ:HUMA) stock rallied 19% Monday on news that the company has received FDA regenerative medicine advanced therapy, or RMAT, designation for its product candidate Acellular Tissue Engineered Vessel, or ATEV, for the treatment of peripheral artery disease. The biotech company noted it was the third RMAT designation forContinue Reading
Genmab (GMAB) and partner AbbVie (NYSE:ABBV) have received U.S. FDA approval for their monoclonal antibody Epkinly (epcoritamab-bysp) for the treatment of adults with relapsed or refractory follicular lymphoma. The approval is based on results from Phase 1/2 EPCORE NHL-1 study, which demonstrated durable, clinically meaningful treatment responses in patients withContinue Reading
Grandbrothers/iStock Editorial via Getty Images Ionis Pharmaceuticals (NASDAQ:IONS) traded higher Tuesday after the U.S. FDA accepted to review a marketing application for its anti-lipid therapy olezarsen, targeted at a rare genetic condition known as familial chylomicronemia syndrome (FCA). Granting priority review for Ionis’ (IONS) New Drug Application (NDA) for olezarsen,Continue Reading
