Faced with defending its COVID-19 vaccine in the face of troubling side effects, Moderna held a conference call late last week to discuss the risk of heart inflammation in young…

Three days before the clock was set to run out on the legality of Janet Woodcock serving as acting commissioner of the FDA, President Biden has announced that he will…

The European Medicines Agency’s (EMA) human medicines committee recommended approving 11 new therapies during its monthly meeting last week. Source: Drug Industry Daily

Johnson & Johnson (J&J) plans to spin off its over-the-counter consumer products unit from its more lucrative prescription drugs and medical devices division, splitting itself into two publicly traded companies…

Sponsors seeking accelerated approval from the FDA should know that a required postapproval confirmatory trial takes about seven months longer than the typical phase 3 trial, leading some researchers to…

In order to be cost-effective relative to standard Alzheimer’s care, Aduhelm — the newly approved Alzheimer’s antibody — would have to cost no more than $3,000 per year, rather than…

Using outmoded dosing structures, oncologists may be giving patients unnecessarily high doses of cancer meds, which provides no added benefit to the patient and, in fact, causes unnecessary side effects.…

The European Medicines Agency (EMA) has given the thumbs up to two COVID-19 antibody therapies from Regeneron-Roche and Celltrion Healthcare, paving the way for imminent approval by the European Commission.…

Lecanemab, the antiamyloid antibody being jointly developed by Eisai and Biogen, grabbed the clinical trial world with a fresh look at extension data and news of its inclusion in an…

The European Medicines Agency (EMA) has recommended including transverse myelitis, a rare form of spinal inflammation, to the list of Johnson & Johnson (J&J) COVID-19 vaccine side effects. Source: Drug…