💊 FDA Center — TodayBestStocks
FDA Drug Approvals & PDUFA Calendar 2026
Track the latest FDA drug approvals and upcoming PDUFA decision dates. June 2026 was one of the busiest months on the regulatory calendar — covering oncology, endocrinology, dermatology, and more.
📅 Updated July 1, 2026
🏥 Real FDA Data
📈 Stock Impact Covered
Novel Approvals (2026 YTD)
28+
As of Jun 30, 2026
June 2026 Approvals
8
Busiest month of year
July 2026 PDUFA Dates
6+
Key decisions ahead
Acting Commissioner
Kyle D.
Since May 2026
✅ Recent FDA Approvals — June 2026
Tryngolza (Olezarsen)
Ionis Pharmaceuticals — $IONS
First Therapy to Reduce Acute Pancreatitis Risk in Severe Hypertriglyceridemia
Approved ahead of its June 30 PDUFA date for adults with severe hypertriglyceridemia (TG ≥500 mg/dL). CORE & CORE2 trials showed 49–72% triglyceride reduction and 85% fewer pancreatitis events vs placebo.
Lumvoa (Veligrotug-vvze)
Viridian Therapeutics — $VRDN
First TED Therapy Approved for Both Active & Chronic Thyroid Eye Disease
IGF-1R inhibitor approved for thyroid eye disease regardless of activity or duration — the first TED therapy labeled for both active and chronic disease, regardless of disease stage.
Tzield (Teplizumab)
Sanofi — $SNY
First Disease-Modifying Therapy for Children with Stage 3 Type 1 Diabetes
Accelerated approval for children aged 8–17 recently diagnosed with stage 3 type 1 diabetes — making it the first disease-modifying treatment in this indication. Carries a boxed warning for viral reactivation.
Utebzi (Tebipenem Pivoxil)
GSK & Spero Therapeutics — $SPRO
First Oral Carbapenem Antibiotic Approved for Complicated Urinary Tract Infections
Novel oral carbapenem-class antibiotic for adults with complicated UTIs including pyelonephritis. Provides a first oral option in a class previously only available intravenously.
Xocova (Ensitrelvir)
Shionogi Inc.
First Oral Antiviral Approved to PREVENT COVID-19 After Exposure
Approved for adults and adolescents 12+ for post-exposure prophylaxis of COVID-19. SCORPIO-PEP Phase 3 trial showed 67% risk reduction in symptomatic COVID-19 by Day 10 vs placebo. 5-day oral regimen.
Datroway (Datopotamab Deruxtecan)
Daiichi Sankyo & AstraZeneca — $AZN
Full FDA Approval for First-Line Triple-Negative Breast Cancer Treatment
TROP2-directed antibody-drug conjugate approved for adults with unresectable or metastatic triple-negative breast cancer (TNBC) not candidates for immunotherapy. Based on Phase 3 TROPION-Breast02 trial (644 patients).
Skyrizi (Risankizumab) — Pediatric
AbbVie — $ABBV
First IL-23 Inhibitor Approved for Pediatric Plaque Psoriasis & Psoriatic Arthritis
AbbVie's blockbuster IL-23 inhibitor gains a new pediatric indication for plaque psoriasis and psoriatic arthritis in children as young as 6 years old, expanding its addressable market significantly.
Ambelvist (Gadoquatrane)
Bayer HealthCare — $BAYRY
New Low-Dose MRI Contrast Agent Approved for CNS & Body Imaging
Gadolinium-based contrast agent approved for MRI to detect lesions with abnormal vascularity in the CNS and non-CNS body regions. Offers a lower dose alternative to existing contrast agents.
❌ Complete Response Letters (CRLs) Issued
Cytisinicline
Cingulate Inc. — $CING
FDA Issues CRL for Smoking Cessation Drug — Manufacturing Issues Cited
FDA blocked approval of cytisinicline (plant-derived alkaloid) for nicotine dependence due to third-party manufacturing deficiencies. No clinical concerns raised — purely a CMC issue. Company seeking resolution.
Oxylanthanum Carbonate (OLC)
Unicycive Therapeutics — $UNCY
Second CRL Issued for Phosphate Binder — Same Manufacturing Vendor Issue
Second Complete Response Letter issued on its PDUFA date for treatment of hyperphosphatemia in CKD patients on dialysis. FDA cited unresolved deficiencies at third-party manufacturer. No clinical concerns.
⏳ Upcoming PDUFA Decision Dates — July 2026
| PDUFA Date | Drug Name | Company | Condition | Review Type | Stock Impact |
|---|---|---|---|---|---|
| Jul 7, 2026 | Atacicept | Vera Therapeutics | IgA Nephropathy (IgAN) | Priority | $VERA — High impact |
| Jul 2026 | Relacorilant | Corcept Therapeutics | Platinum-Resistant Ovarian Cancer | Standard | $CORT — High impact |
| Jul 2026 | Furoscix ReadyFlow | scPharmaceuticals | Heart Failure / CKD Edema | sNDA | $SCPH — Moderate |
| Aug 24, 2026 | LEQEMBI IQLIK (Extended) | Eisai / Biogen | Early Alzheimer's Disease | Priority | $BIIB $ESALY — Watch |
🏥 Why FDA Approvals Matter for Investors: FDA approvals can cause stocks to move 20–100%+ in a single day. Biotech and pharma stocks often run up before a decision date and sell off after — even on positive news. Always understand the risk before trading around FDA catalyst events.
⚠️ Medical Disclaimer: All FDA approval information on TodayBestStocks.com is for informational and educational purposes only. It does not constitute medical advice. For medical decisions, always consult a qualified healthcare professional. For investment decisions, always consult a licensed financial advisor.
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