Moderna Inc.’s chief medical officer said on Sunday the company’s vaccine for children under 6 years old will be ready for review by a Food and Drug Administration panel when it meets in June.

The U.S. Food and Drug Administration (FDA) approved Bristol Myers Squibb’s oral heart disease drug, making Camzyos (mavacamten) the first cardiac myosin inhibitor to be permitted for use in the country.

Merck

Merck announced the company’s Q1 2022 results, reporting year-over-year revenue growth of 50 percent from continuing operations, with worldwide sales increasing to $15.9 billion. As anticipated, Merck’s COVID-19 antiviral treatment Lagevrio (molnupiravir) played a role in the company’s robust sales.

Pfizer Inc. said on April 28 the company would open the first U.S. trial sites for its experimental gene therapy for a muscle-wasting disorder, after the Food and Drug Administration lifted the regulatory agency’s hold on a late-stage study.

Axsome Therapeutics said on April 25 the company expects the U.S. health regulator to decline approval for the drug developer’s treatment of acute migraine over unresolved issues of its quality control processes, sending shares of Axsome down 20 percent.

The U.S. Food and Drug Administration asked people to not buy or use certain dietary supplement products sold with variations of the names ‘Artri’ or ‘Ortiga’ as they may contain some potentially harmful ingredients not mentioned on their labels.

The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers.

The U.S. Food and Drug Administration extended by three months the regulatory agency’s review of the Biologics License Application (BLA) for Regeneron Pharmaceuticals Inc.’s REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.

Gilead Sciences Inc. said on April 11 the U.S. Food and Drug Administration had lifted the partial clinical hold placed on the company’s trials testing a blood cancer drug combination.

Eisai

Eisai Co. Ltd. and Eli Lilly and Co. on April 8 said they still plan to seek accelerated U.S. approval for experimental Alzheimer’s drugs even after the Medicare health plan decided to severely limit coverage of medicines approved in that manner.