The FDA’s approvals process appeared to be on shaky ground last year. The agency missed multiple PDUFA dates and rendered several controversial decisions, such as initially declining to review the application for Moderna’s seasonal flu vaccine, mRNA-1010.

Despite the hiccups, the FDA ended 2025 having OK’d 46 drugs — only four fewer than it approved in 2024. This year the agency is on-pace to return to its average approval rate of 47 novel drugs, with 24 given the go-ahead as of July 7. 

The agency also recently paused the publication of drug rejection letters after an unnamed pharma company filed a citizen’s petition against the practice, according to multiple reports. The FDA had ramped up its publication of CRLs as part of a broader crackdown on pharma and increase in criticisms against the industry on multiple fronts. 

Now, some of the drugs that bumped along FDA’s rocky regulatory road last year are up for review, including Moderna’s new shot for seasonal flu, while others on the FDA docket have had a more straightforward path to possible approval.

Here are three approvals to watch. 

Moderna’s hot-button flu jab

Expected decision: Aug. 5.

An FDA approval of its mRNA-1010 would provide the market with a seasonal flu vaccine that’s more effective than current options, the biopharma giant argued during a FDA committee presentation last month. The approval could also signal a positive shift in the FDA’s attitude toward mRNA technology.

Moderna specifically designed mRNA-1010 to overcome challenges that plague existing flu vaccines. The new shot incorporates precise antigen matching, isn’t egg-based and has a quicker and more flexible production timeline, allowing for more precise annual influenza strain selection, in addition to greater effectiveness, according to Moderna’s FDA committee presentation.

Last month, an FDA advisory panel unanimously voted in favor of mRNA-1010’s risk-benefit profile, both for adults 50 through 64 years and adults 65 years of age and older, marking an important development ahead of the vaccine’s Aug. 5 PDUFA date.

Despite this positive data, a friendly attitude from the FDA isn’t a foregone conclusion. Earlier this year, the FDA initially declined to review Moderna’s application for mRNA-1010, though it reversed course eight days later after the company proposed a regulatory pathway based on age. This all played out against a regulatory backdrop of deeper mRNA hostility, including about $500 million in canceled contracts through the Biomedical Advanced Research and Development Authority, which terminated 22 mRNA vaccine projects last year. HHS Secretary Robert F. Kennedy, Jr. has personally attacked mRNA vaccines, warning, without evidence, they are unsafe and can have far-reaching side effects. 

Beyond the upcoming decision date, Moderna’s pipeline highlights include initiating late-stage trials of intismeran autogene mRNA-4157 in oncology and mRNA-1018 in pandemic flu.

Capricor’s potential DMD breakthrough

Expected decision: Aug. 22.

Capricor Therapeutics is taking a second swing at approval for its Duchenne muscular dystrophy cell therapy Deramiocel after an FDA rejection last year.

DMD is a devastating, progressive genetic muscle disorder that degenerates the skeletal, respiratory and cardiac muscles. Patients with the condition don’t usually live past 30, and their leading cause of death is cardiomyopathy and heart failure. There is no cure and current treatment options are limited. 

If approved, Deramiocel would become the first therapy to address both skeletal and cardiac manifestations of Duchenne muscular dystrophy, according to Capricor.

In its rejection last year, the FDA asked Capricor for additional clinical data while also flagging outstanding items in the manufacturing elements of its application. Denials due to quality or manufacturing concerns are common. Between 2020 and 2024, 74% of CRLs were driven by gaps in process control, insufficient stability data or unresolved issues from GMP inspections. The FDA delayed drugs from Ultragenyx and Rocket Pharmaceuticals for similar reasons last year.

This time around, Capricor has resolved its CMC issues and submitted additional phase 3 data. 

Takeda could cross the narcolepsy finish line first with an orexin drug

Expected decision: Before Sept. 30.

Orexin-based drugs have been generating more buzz as drugmakers tout their broad potential across a range of neurological conditions. And narcolepsy has become the frontline for a battle to get a new orexin drug to market, with Takeda Pharmaceuticals, Alkermes, Centessa Pharmaceuticals and Eisai all developing orexin drugs targeting the sleep-wake disorder. So far, Takeda Pharmaceuticals is in the lead.  

The company’s oral treatment oveporexton was designed to target the underlying orexin deficiency that drives narcolepsy Type 1 by restoring orexin signaling, and has a PDUFA date slated for the third quarter. 

“What’s exciting about oveporexton is that it doesn’t target the symptoms, but it actually targets the root cause,” Jon Roffman, global head of biopharma for healthcare and tech consulting firm ZS, told PharmaVoice earlier this year. “It’s very exciting to see a therapy that’s going to change the course of the disease state.”

Phase 3 data showed the drug significantly improved symptoms, including excessive daytime sleepiness and a type of muscle weakness called cataplexy. Additional data revealed more benefits including improvements in cognition.

Despite these results, the drug could face reimbursement and diagnosis hurdles if it lands on the market because it’s a rare condition that’s often under-diagnosed, Roffman said.

“Finding the right patients and getting the therapy to the right patients is going to require improvements in testing and improvements in the patient journey,” he said.