Cidara Ther­a­peu­tics wants to make its mark in the world of an­ti­fun­gals, and thanks to the FDA, it may get there soon.

The San Diego-based com­pa­ny an­nounced Tues­day that the FDA has giv­en pri­or­i­ty re­view to its an­ti­fun­gal reza­fun­gin for the treat­ment of can­didemia and in­va­sive can­didi­a­sis — com­mon caus­es of se­ri­ous blood­stream in­fec­tions in hos­pi­tal­ized pa­tients, per the CDC. No new ther­a­pies have been ap­proved in over a decade for the two in­fec­tions, the com­pa­ny said in a press state­ment. Reza­fun­gin’s re­view dead­line date is set for March 22, 2023.

The new drug sub­mis­sion was based on re­sults from its glob­al Re­STORE Phase III and STRIVE Phase II tri­als, which showed the drug’s non-in­fe­ri­or­i­ty over caspo­fun­gin, the cur­rent stan­dard of care.

“If ap­proved, reza­fun­gin would rep­re­sent an im­por­tant new treat­ment op­tion for pa­tients at risk of these po­ten­tial­ly dead­ly dis­eases,” said Cidara’s CEO Jef­frey Stein.

Mean­while, the com­pa­ny is cur­rent­ly con­duct­ing a sec­ond Phase III study to ex­am­ine the drug as a pro­phy­lac­tic for in­va­sive fun­gal dis­ease in pa­tients un­der­go­ing al­lo­gene­ic blood and mar­row trans­plan­ta­tion.

In Ju­ly 2022, the com­pa­ny struck a li­cense agree­ment with Melin­ta Ther­a­peu­tics, grant­i­ng the lat­ter an ex­clu­sive li­cense to com­mer­cial­ize reza­fun­gin in the US.

“This trans­ac­tion elim­i­nates the need for Cidara to build com­mer­cial in­fra­struc­ture to launch reza­fun­gin in the U.S.,” Stein said in a Ju­ly 27 press state­ment.

The com­pa­ny li­censed the drug to Mundiphar­ma for oth­er parts of the world ex­cept for Japan, where Cidara con­tin­ues to hold the rights.

A few oth­er com­pa­nies are al­so de­vel­op­ing an­ti­fun­gals. One of those, New Jer­sey-based biotech Scynex­is, is de­vel­op­ing its drug ibrex­a­fungerp to fight fun­gal in­fec­tions in a hos­pi­tal set­ting.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.