The U.S. Food and Drug Administration granted marketing clearance for Ryplazim as the first FDA-approved therapy for the treatment of patients with the plasminogen deficiency type 1 (hypoplasminogenia), a rare genetic disorder.
The U.S. Food and Drug Administration on June 4 approved Danish drugmaker Novo Nordisk’s once-weekly semaglutide drug as a treatment for obesity, a condition that affects nearly 70% of American adults.
The U.S. Food and Drug Administration approved Biohaven Pharmaceutical Holding Company Ltd.’s Nurtec ODT (rimegepant 75 mg) for the preventive treatment of migraine. Nurtec ODT is indicated for adult patients with episodic migraine, e.g. those who experience less than 15 headache days per month.
Some teenagers and young adults who received Covid-19 vaccines experienced heart inflammation, a U.S. Centers for Disease Control and Prevention advisory group said, recommending further study of the rare condition.
Medicago and GlaxoSmithKline reported positive interim Phase 2 clinical trial safety and immunogenicity data for Medicago’s plant-derived Covid-19 vaccine candidate, which has been tested in combination with GSK’s pandemic adjuvant.
Sanofi and GlaxoSmithKline reported positive data on their Covid-19 vaccine candidate in all adult age groups in a Phase II trial of 722 volunteers. The companies expect to launch a global pivotal Phase III trial in the coming week.
Inovio Pharmaceuticals Inc. said the company’s Covid-19 vaccine candidate was safe, well-tolerated and produced immune response against the new coronavirus in a mid-stage clinical trial, sending the drug developer’s shares up over 3 percent.
President Joe Biden on May 4 announced a goal to vaccinate 70 percent of U.S. adults with at least one Covid-19 shot by the July 4 Independence Day holiday and said the government would innoculate 12- to 15-year-olds as soon as allowed. The president had previously announced July 4 as a target date for Americans to gather in small groups to celebrate the holiday and signal a return to greater normalcy in the middle of the pandemic.
Passage Bio Inc. and InformedDNA announced a collaboration to provide no-cost genetic counseling and testing for adults who have been diagnosed by their physicians with Frontotemporal Dementia (FTD).
An investigational Alzheimer’s disease (AD) drug from Tetra Therapeutics appeared to improve language ability and learning in adults with Fragile X Syndrome, according to a new study reported in Nature Medicine.