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Approvals for Merck & Co., J&J; designations for AstraZeneca, Roche

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Approvals for Merck & Co., J&J; designations for AstraZeneca, Roche

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Sept. 20.

Approvals

* Merck & Co. Inc. and Eisai Co. Ltd.'s combination of Keytruda and Lenvima for endometrial carcinoma.

* Johnson & Johnson's Erleada for patients with metastatic castration-sensitive prostate cancer.

* Merck & Co.'s Delstrigo and Pifeltro for HIV-1 patients with undetectable levels of the virus in their blood who are on a stable antiretroviral regimen with no prior treatment failure and no known substitutions associated with resistance to the Merck drugs.

* Zimmer Biomet Holdings Inc.'s JuggerStitch for meniscus tear in the knee via keyhole surgery. The FDA granted 510(k) clearance to the device.

SNL ImageFDA headquarters in Silver Spring, Md.
Source: Associated Press

Priority review

* Merck & Co.'s V920 vaccine to prevent Ebola disease caused by the Ebola Zaire virus.

* Astellas Pharma Inc. and Seattle Genetics Inc.'s enfortumab vedotin for patients with urothelial cancer whose disease progressed locally or has spread to other parts of the body despite receiving treatment in the past, including immunotherapies and chemotherapy.

Fast track

* AstraZeneca PLC's Farxiga to reduce the risk of cardiovascular death in patients with either reduced ejection fraction or preserved ejection fraction.

* Wave Life Sciences Ltd.'s suvodirsen for Duchenne muscular dystrophy.

Breakthrough therapy

* Roche Holding AG's Gazyva for adults with lupus nephritis.

Other designations

* Orphan drug, for Bellerophon Therapeutics Inc.'s nitric oxide therapy for idiopathic pulmonary fibrosis.

* Regenerative medicine advanced therapy, for SanBio Co. Ltd. and SanBio Inc.'s SB623 for chronic neurological motor deficits following a brain injury.