The 12-month wind-down for therapeutics and 180-day transition for medical devices signal a definitive shift back to standard regulatory pathways, forcing manufacturers like Invivyd to pursue full FDA ...

NCCN now recommends pemivibart pre-exposure prophylaxis for patients with B-cell lymphomas and other profoundly ...

Households exposed to COVID-19 now have an oral drug specifically cleared to prevent infection after contact with a sick ...

U.S. Department of Health and Human Services (HHS) announced advanced Notice of Termination of the COVID-19 EUA declaration, effective June 29, ...

FDA Drug Approvals and Regulatory Updates Drug Pharmacologic class Indication More information Cardiovascular Disease Tryngolza (olezarsen) Apolipoprotein ...

Data from LIBERTY can provide important insight into the VYD2311 clinical profile by direct comparison between COVID antibody prophylaxis and COVID vaccine LIBERTY is part of Invivyd’s broader ...

Multiple new clinical trials are underway to evaluate if various treatments will prove effective against the Bundibugyo Ebola ...

Coronavirus: India has banned the export of hydroxychloroquine, an anti-Malaria drug that is believed to work as a medicine ...

The strain of the virus that's responsible for the current outbreak has no specific treatments or preventive measures. Three ...

LIBERTY clinical trial will evaluate the comparative safety and tolerability of VYD2311 versus mRNA COVID-19 vaccine, as well as explore the safety and immunology of co-administer ...

Genmab A/S(Nasdaq: GMAB) announced today that the European Commission (EC) granted marketing authorization for TEPKINLY ® (epcoritamab) in combination with lenalidomide and rituximab (TEPKINLY + R 2 ) ...

DECLARATION is a Phase 3, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of VYD2311 in the prevention of symptomatic COVID-19 versus placebo, at three months, from a ...