After an earlier rejection from the U.S. Food and Drug Administration, Merck’s vaunted checkpoint inhibitor Keytruda won approval for the treatment of patients with high-risk, early-stage triple-negative breast cancer.
Moderna Inc. is in talks with U.S. regulators to expand the size of an ongoing trial testing the company’s Covid-19 vaccines in children aged between 5 and 11 years, the drugmaker said on July 26.
Shares of Iterum Therapeutics plunged on July 26 after the U.S. Food and Drug Administration rejected the company’s New Drug Application for oral sulopenem as a potential treatment for uncomplicated urinary tract infections (uUTI) in patients with a quinolone non-susceptible pathogen.
The U.S. Food and Drug Administration issued Incyte Corporation with a Complete Response Letter (CRL) over the company’s Biologics License Application (BLA) for retifanlimab for anal cancer.
International eye-care products manufacturer Allergan announced positive outcomes from the AbbVie company’s Phase 3 study of a new treatment for presbyopia, as the ophthalmic solution AGN-190584 met primary and key secondary endpoints.
Despite reports of a rare neurological disorder appearing in some people who have received Johnson & Johnson’s Covid-19 vaccine, the benefits of its use outweigh the risks, a U.S. Centers for Disease Control and Prevention advisory panel said on July 22.
Switzerland-based Roche is in talks with the U.S. Food and Drug Administration over the company’s Alzheimer’s drug candidate gantenerumab, which is being evaluated in clinical studies with a large-scale Phase III trial expected to wrap in the second half of 2022.
The U.S. Food and Drug Administration approved the combination of Merck’s anti-PD-1 therapy Keytruda plus Eisai’s orally available multiple receptor tyrosine kinase inhibitor Lenvima for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
Anthem Inc. is closely watching for guidance from the U.S. Food and Drug Administration and all available clinical evidence on Biogen Inc.’s Aduhelm to determine the health insurance provider’s coverage policy on the newly approved Alzheimer’s drug.
The U.S. Food and Drug Administration greenlit the classification of California-based biotechnology firm Genentech’s Venclexta (venetoclax) and azicitidine combination as a Breakthrough Therapy Drug.
