The FDA has granted emergency use authorization (EUA) to InflaRx’s vilobelimab, now to be marketed as Gohibic, for hospitalized adult patients with COVID-19, the German biotech announced Tuesday.

FDA

The U.S. health regulator said on Wednesday that it is working to address a shortage of a particular form of albuterol, a medication used to treat breathing conditions, as its sole manufacturer Akorn has stopped production.

FDA

After the flurry of verdicts and meetings at the end of February, the FDA has a relatively quiet week ahead with only two stand-out events.

Leqembi

Japanese drugmaker Eisai Co. Ltd. and its U.S. partner Biogen Inc. said on Monday that the U.S. Food and Drug Administration granted priority review for traditional approval of their Alzheimer’s treatment lecanemab.

Contaminated cough and paracetamol syrups imported into Gambia almost certainly caused the deaths of 66 children due to acute kidney injury, according to an investigation led by the United States Center for Disease Control and Prevention and Gambian scientists.

Pfizer Inc. and its German partner BioNTech SE (22UAy.DE) have applied for emergency use authorization of their Omicron-adapted COVID-19 vaccine in the United States as a booster dose for children aged six months through four years, the companies said on Wednesday.

Citing lack of efficacy evidence, the FDA rejected Cytokinetics’ heart failure hopeful omecamtiv mecarbil in a Tuesday evening decision.

FDA

Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) deemed there were enough data to support Pfizer’s respiratory syncytial virus (RSV) vaccine RSVpreF in adults aged 60 and older.

Eli Lilly

Eli Lilly & Co. said on Tuesday all doses of its new diabetes drug Mounjaro were now available with wholesalers having inventory on hand after a two-month-long shortage.

Johnson & Johnson

The U.S. Supreme Court on Tuesday let stand a $302 million judgment against Johnson & Johnson in a lawsuit brought by the state of California accusing the company of concealing the risks of its pelvic mesh products.