What if AI could use digital health data to correctly identify the early signs of a serious health issue that is extremely hard to diagnose, yet widespread in hospital settings? In one recent example of healthcare innovation, a cutting-edge AI system that analyzes...
Pfizer has announced Thursday that it received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for its vaccine candidate PF-06928316 (RSVpreF), intended to prevent infections caused by a respiratory syncytial virus (RSV). The respiratory...
Moderna reported positive interim results from the Phase II/III KidCOVE trial of its mRNA COVID-19 vaccine for children six months to under two years and two to six years of age. The data showed a “robust neutralizing antibody response” in both cohorts. The doses were...
Takeda faces yet another setback by the U.S. Food and Drug Administration for its parathyroid hormone, natpara. Natpara is intended to help patients navigate low blood calcium due to hypoparathyroidism. In Sept. 2019, Takeda issued a U.S. recall of all natpara for...
Bristol Myers Squibb (BMS) achieved a monumental milestone when the U.S. Food and Drug Administration approved Opdualag (nivolumab and relatlimab-rmbw) for the treatment of patients 12 and older with unresctable or metastatic melanoma. The decision is based on the...
Moderna formally requested the FDA grant emergency authorization for a second booster shot of its COVID-19 vaccine for all adults over 18 who have received approved vaccines. Earlier this week, Pfizer and its partner BioNTech also requested authorization for a second...
Viral infections can have a broad range of side effects, such as myocarditis, and COVID-19 is no different. There is evidence that COVID-19 infection might be linked to an increase in diabetes, particularly Type 1 diabetes, an autoimmune disease most commonly...
Several biopharma companies celebrate the U.S. Food and Drug Administration’s approval for clinical trials involving therapeutics for cancer treatment, including Sonnet BioTherapeutics and Adagene. Sonnet BioTherapeutics evolved into a clinical biopharmaceutical...
Arrowhead Pharmaceuticals, Inc. has announced that it has filed an application for clearance to initiate a Phase 1/2a clinical trial of ARO-RAGE, the company’s investigational RNA interference (RNAi) therapeutic designed to reduce production of the receptor for...
Asieris Pharmaceuticals, in accordance with advice from the National Medical products Administration Center for Drug Evaluation (CDE), has approved the inclusion of Asieris’s drug Hexvic®, a drug for the diagnosis of bladder cancer, in the clinical real-world world...
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