The second half of 2026 is shaping up to be one of the most consequential periods for FDA drug approval decisions in recent memory. Between mid-July and late August, the US Food and Drug Administration faces a succession of Prescription Drug User Fee Act target action dates spanning oncology, neurology, rare disease, infectious disease, and nephrology. Several of these decisions carry blockbuster commercial potential, while others could deliver genuinely first-in-class therapies to patients with limited or no existing treatment options.
The window follows an already eventful first half of the year. On 7 July 2026, the FDA granted accelerated approval to atacicept (Trutakna; Vera Therapeutics) for adults with IgA nephropathy, making it the first dual BAFF and APRIL inhibitor cleared for the progressive kidney disease. The previous week, Orca Bio’s Tregzi became the first regulatory T-cell therapy approved in the United States. These FDA drug approval decisions set the stage for what promises to be an equally significant stretch ahead.
What follows is a guide to the most significant FDA drug approval decisions expected in the coming weeks, covering the clinical evidence behind each candidate, the patient populations at stake, and the regulatory context shaping the agency’s review.
Gedatolisib: a new option for advanced breast cancer
Celcuity’s gedatolisib faces a PDUFA target action date of 17 July 2026 for the treatment of hormone receptor-positive (HR+), HER2-negative, PIK3CA wild-type advanced breast cancer. The NDA was submitted under the FDA’s Real-Time Oncology Review programme and received Priority Review and Breakthrough Therapy designation.
Gedatolisib is a multi-target PI3K/AKT/mTOR inhibitor that blocks all four Class I PI3K isoforms, mTORC1, and mTORC2. This mechanism is mechanistically distinct from currently approved single-target inhibitors. The pivotal Phase 3 VIKTORIA-1 trial demonstrated notable efficacy in patients whose disease had progressed on CDK4/6 inhibitor and aromatase inhibitor therapy. In the PIK3CA wild-type cohort, the gedatolisib triplet regimen (combined with palbociclib and fulvestrant) achieved a median progression-free survival of 9.3 months compared with 2.0 months for fulvestrant alone (hazard ratio 0.24; p<0.0001), with an objective response rate of 31.5%.
If approved, gedatolisib would become the first treatment specifically indicated for PIK3CA wild-type patients, a population that represents roughly 60% of second-line HR+ breast cancer cases and an estimated 37,000 patients per year in the United States. HR+/HER2-negative disease is the most common breast cancer subtype, accounting for approximately two-thirds of all diagnoses, and resistance to CDK4/6 inhibitors remains a critical treatment challenge.
Centanafadine: a first-in-class approach to ADHD
Otsuka Pharmaceutical’s centanafadine has a PDUFA target action date of 24 July 2026 for the treatment of ADHD in children, adolescents, and adults. The FDA granted Priority Review to the NDA in January 2026.
Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), offering a mechanism of action distinct from both existing stimulant and non-stimulant ADHD therapies. No other approved ADHD medication simultaneously modulates all three neurotransmitters. The NDA is supported by four pivotal Phase 3 clinical trials across children, adolescents, and adults. In these trials, centanafadine demonstrated statistically significant improvements in ADHD symptoms compared with placebo, as measured by standard rating scales. It was generally well tolerated, with the most common adverse events including decreased appetite and headache in adults, and decreased appetite, nausea, rash, and abdominal pain in children and adolescents.
Additional data presented in June 2026 showed positive results from a Phase 3b study in adults with ADHD and comorbid anxiety, an area of significant unmet need. Post hoc analyses also suggested improvements in executive function and emotional dysregulation, two features of ADHD that contribute substantially to the burden of illness. Preclinical and clinical data suggest centanafadine may present a low abuse risk, which could distinguish it from stimulant alternatives. With an estimated 15.5 million adults in the United States currently diagnosed with ADHD, a new class of treatment could represent a meaningful expansion of options.
Moderna mRNA-1010: an mRNA flu vaccine for over-50s
Moderna’s mRNA-1010, an investigational seasonal influenza vaccine, carries a PDUFA target action date of 5 August 2026. The journey to this point has been far from straightforward. In February 2026, the FDA issued a refusal-to-file letter for Moderna’s initial BLA, citing concerns about the comparator used in the pivotal trial for adults aged 65 and over. A constructive Type A meeting between Moderna and the FDA’s Center for Biologics Evaluation and Research led to a revised regulatory approach, with the agency agreeing to review the vaccine through a two-track strategy.
For adults aged 50 to 64, the FDA will consider traditional approval. For those aged 65 and over, the pathway is accelerated approval with a postmarketing study commitment. The approach reflects a technical disagreement about whether a standard-dose licensed comparator adequately represented the best available influenza vaccination for older adults.
The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously in favour of mRNA-1010’s benefit-risk profile in June 2026. If approved, the vaccine could become available for US adults aged 50 and over in time for the 2026 to 2027 influenza season. Regulatory submissions have also been accepted in Europe, Canada, and Australia. For Moderna, approval would represent a critical commercial milestone, extending its mRNA platform beyond COVID-19 vaccines into the broader respiratory market. The FDA drug approval decisions in this window will be closely watched for signals about the agency’s appetite for mRNA-based vaccines in established markets.
Padcev plus Keytruda: expanding into cisplatin-eligible bladder cancer
The combination of enfortumab vedotin (Padcev; Astellas and Pfizer) with pembrolizumab (Keytruda; Merck) faces a PDUFA target action date of 17 August 2026 for the perioperative treatment of patients with muscle-invasive bladder cancer who are eligible for cisplatin-based chemotherapy.
This follows the November 2025 FDA approval of the same combination for cisplatin-ineligible patients, based on the Phase 3 EV-303 (KEYNOTE-905) trial. The current supplemental BLA is supported by the Phase 3 EV-304 (KEYNOTE-B15) trial, which demonstrated a 47% reduction in the risk of disease recurrence, progression, or death compared with standard neoadjuvant gemcitabine and cisplatin, alongside a 35% reduction in the risk of death. Pathologic complete response rates were substantially higher with the combination at 55.8%, compared with 32.5% for chemotherapy.
If approved, the Padcev-Keytruda regimen would become the first and only perioperative treatment for patients with muscle-invasive bladder cancer regardless of cisplatin eligibility. More than half of patients with this disease experience recurrence after surgery, making perioperative treatment a critical area of unmet need. The decision is expected to have significant implications for standard-of-care guidelines and commercial positioning, given that the antibody-drug conjugate and checkpoint inhibitor combination has already established itself as a leading regimen in advanced urothelial cancer.
Deramiocel: a second chance for Duchenne muscular dystrophy
Capricor Therapeutics’ deramiocel (CAP-1002), an investigational allogeneic cardiosphere-derived cell therapy, has a PDUFA target action date of 22 August 2026 for Duchenne muscular dystrophy (DMD) cardiomyopathy. The path to this date has been particularly eventful. The FDA issued a Complete Response Letter in July 2025, stating that the original BLA, based primarily on the Phase 2 HOPE-2 study, did not meet the threshold for substantial evidence of effectiveness.
Capricor responded by submitting data from the Phase 3 HOPE-3 trial, prompting the FDA to lift the CRL and resume review. HOPE-3 demonstrated statistically significant benefits across both skeletal muscle and cardiac endpoints. Cardiac MRI analyses showed a significant reduction in myocardial fibrotic segments in patients treated with deramiocel compared with placebo (p=0.022), and the Duchenne Video Assessment, which captures real-world functional tasks, correlated with improvements in upper limb performance.
If approved, deramiocel would become the first therapy to address both the skeletal and cardiac manifestations of DMD, a distinction that matters for a condition in which cardiomyopathy is a leading cause of death. The therapy has received Orphan Drug Designation, Regenerative Medicine Advanced Therapy designation, and Rare Pediatric Disease Designation, the last of which may qualify Capricor for a Priority Review Voucher upon approval.
LEQEMBI IQLIK: eliminating the IV requirement in Alzheimer’s treatment
Eisai and Biogen’s supplemental BLA for LEQEMBI IQLIK (lecanemab) as a subcutaneous starting dose for early Alzheimer’s disease carries a PDUFA target action date of 24 August 2026. The date was extended from the original May deadline after the FDA determined that additional information submitted by the companies constituted a major amendment.
The FDA approved the subcutaneous formulation for maintenance dosing in August 2025, enabling patients to switch from intravenous infusions to a once-weekly at-home autoinjector after 18 months of initial IV treatment. The current application seeks to extend subcutaneous use to the initiation phase, which would eliminate the need for IV infusions entirely. This is a commercially and practically significant step. Lecanemab uptake has been slower than initially projected, with infusion logistics, monitoring requirements, and patient burden cited as contributing factors. Approval of the subcutaneous starting dose could address these barriers and accelerate adoption. Lecanemab has been approved in more than 50 countries worldwide, and its subcutaneous formulation is also under review in Japan and China.
Bictegravir plus lenacapavir: simplifying HIV treatment
Gilead Sciences’ single-tablet combination of bictegravir 75 mg and lenacapavir 50 mg (BIC/LEN) has a PDUFA target action date of 27 August 2026 for the treatment of adults with HIV who are virologically suppressed. The FDA granted Priority Review to the NDA in April 2026.
BIC/LEN pairs bictegravir, a guideline-recommended integrase strand transfer inhibitor with a high barrier to resistance, with lenacapavir, a first-in-class capsid inhibitor that has no cross-resistance with other antiretroviral classes. Lenacapavir is already approved in multiple countries both for multi-drug-resistant HIV treatment and as pre-exposure prophylaxis.
Phase 3 results from the ARTISTRY-1 and ARTISTRY-2 trials, published in The Lancet in March 2026 and presented at CROI 2026, demonstrated that switching to BIC/LEN maintained high levels of virological suppression. In ARTISTRY-2, BIC/LEN was non-inferior to Biktarvy, Gilead’s own standard-of-care single-tablet regimen, with 1.3% of participants on BIC/LEN having detectable viral load at 48 weeks compared with 1.0% on Biktarvy. ARTISTRY-1 showed comparable efficacy in patients switching from complex multi-tablet regimens, including those taking between two and eleven pills daily. If approved, BIC/LEN would be the smallest single-tablet regimen for HIV treatment and the first studied specifically in adults on complex multi-tablet regimens.
Further FDA drug approval decisions on the horizon
Beyond these headline decisions, several additional PDUFA dates in this window are worth tracking, each carrying its own clinical and commercial significance. Sanofi faces a 23 July 2026 decision on a subcutaneous formulation of Sarclisa (isatuximab) for multiple myeloma, which could simplify administration of a therapy currently given intravenously. On the same date, Elevar Therapeutics awaits a decision on rivoceranib in combination with camrelizumab for hepatocellular carcinoma.
In August, Bristol Myers Squibb’s iberdomide in combination with daratumumab and dexamethasone has a 17 August PDUFA date for relapsed or refractory multiple myeloma, representing the first cereblon E3 ligase modulator to reach the FDA for this indication. Ultragenyx Pharmaceutical faces a 23 August decision on DTX401, a gene therapy for glycogen storage disease type Ia, while ITM Isotope Technologies Munich awaits a 28 August decision on 177Lu-edotreotide, a radiopharmaceutical for gastroenteropancreatic neuroendocrine tumours.
Regulatory context and what lies ahead
These FDA drug approval decisions are being made against a backdrop of continued leadership transition at the agency. The departure of Commissioner Marty Makary in May 2026 and the appointment of Acting Commissioner Kyle Diamantas introduced questions about regulatory continuity that have only partially been resolved. Industry observers have noted that despite the institutional disruption, the FDA has continued to meet its PDUFA commitments, with several decisions in the first half of 2026 arriving ahead of schedule. For a broader explanation of how these regulatory deadlines work, the PDUFA date mechanism underpins every decision in this calendar.
The concentration of high-profile decisions in this window reflects broader trends in pharmaceutical development: the maturation of antibody-drug conjugate and cell therapy platforms, the expansion of mRNA technology beyond COVID-19, the simplification of HIV treatment regimens, and the persistent effort to bring first-in-class therapies to underserved patient populations. How the FDA navigates these reviews will shape treatment paradigms, commercial landscapes, and the agency’s own credibility during a period of unusual institutional flux.
For the life sciences sector, the next eight weeks are unlikely to be quiet.
