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The FDA in February slapped Moderna’s vaccine with a refusal-to-file letter—though the agency backtracked a few days later and accepted a revised submission for review. An advisory committee in June unanimously backed mFLUVISA’s approval.

FDA extends its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy as an unhappy shareholder advocates for change; Merck and Moderna tout positive data for their mRNA-based cancer vaccine; Trump nominates White House aide Heidi Overton as FDA commissioner; and the oral obesity market heats up with rivals Eli Lilly and Novo Nordisk going head-to-head.

Moderna’s norovirus vaccine failed in a Phase 3 trial, but the company still has faith in an ambitious revenue growth target thanks to ex-U.S. vaccine sales and a unanimous FDA adcomm win for mFLUSIVA.

Following their blowout win in melanoma last month, Merck and Moderna are leading the way among a new crop of personalized cancer vaccines. Here are five companies with similar therapies hoping to break through where others have previously failed.

The FDA in February briefly refused to review Moderna’s flu vaccine, citing trial inadequacies, but reversed course a few days later. A verdict is expected by Aug. 5.

When used alongside Merck’s Keytruda, Moderna’s personalized cancer vaccine halved the risk of death or disease recurrence in a mid-stage trial of advanced melanoma—a result analysts said could help “instill confidence” in the regimen.

After getting slapped with a surprise refuse-to-file letter signed by former CBER Director Vinay Prasad, Moderna’s flu vaccine application will now go before the FDA’s Vaccine advisory committee.

Moderna appears to have aligned with the FDA ahead of an advisory committee meeting for its mRNA-based flu vaccine, which the regulator initially turned away in February; biotech IPOs are going gangbusters, including two new records raises in as many weeks; layoffs continue across biopharma; plus much more.

Melanoma was slower to recur in patients receiving Merck and Moderna’s mRNA vaccine with Keytruda, supporting use of the combination in adjuvant treatment. The partners plan to take the data to the FDA.

The Vaccines and Related Biological Products Advisory Committee will meet June 18 to discuss Moderna’s seasonal flu vaccine mRNA-1010 after the FDA initially refused to accept the application in February.