An investigational prophylactic long-acting monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season.
Biologics License Application (BLA)
PDUFA
06/10/2025
06/10/2025
06/10/2025
02/14/2025
06:30 AM
MRNA
Moderna, Inc.
PDUFA
mRESVIA (mRNA-1345)
Respiratory syncytial virus (RSV) vaccine mRESVIA (mRNA-1345) for adults aged 60 years and older
Biologics License Application (BLA)
PDUFA
06/12/2025
06/12/2025
06/12/2025
10/15/2024
04:30 PM
URGN
UroGen Pharma Ltd.
PDUFA
UGN-102 (mitomycin)
Intravesical solution for Low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)
New Drug Application (NDA)
PDUFA
06/13/2025
06/13/2025
06/13/2025
09/03/2024
06:35 AM
KALV
KalVista Pharmaceuticals, Inc.
PDUFA
Sebetralstat
An investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older.
New Drug Application (NDA)
PDUFA
06/17/2025
06/17/2025
06/17/2025
02/18/2025
08:35 AM
GILD
Gilead Sciences, Inc.
PDUFA
Lenacapavir
The twice-yearly injectable HIV-1 capsid inhibitor for the prevention of HIV as pre-exposure prophylaxis (PrEP)
New Drug Application (NDA) Priority Review
PDUFA
06/19/2025
06/19/2025
06/19/2025
04/29/2025
06:35 AM
REGN
Regeneron Pharmaceuticals, Inc.
PDUFA
Dupixent
For moderate-to-severe bullous pemphigoid
supplemental Biologics License Application (sBLA)
PDUFA
06/20/2025
06/20/2025
06/20/2025
02/25/2025
05:50 AM
MRK
Merck
PDUFA
KEYTRUDA® (pembrolizumab) - KEYNOTE-689
The anti-PD-1 therapy, for the treatment of patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, then continued as adjuvant treatment in combination with standard of care radiotherapy with or without cisplatin and then as a single agent.
supplemental Biologics License Application (sBLA)
PDUFA
06/23/2025
06/23/2025
06/23/2025
12/23/2024
08:10 AM
NUVB
Nuvation Bio Inc.
PDUFA
Taletrectinib
An investigational next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of advanced ROS1+ NSCLC (line agnostic).
New Drug Application (NDA) Priority Review
PDUFA
06/23/2025
06/23/2025
06/23/2025
11/11/2024
07:05 AM
UNCY
Unicycive Therapeutics, Inc.
PDUFA
Oxylanthanum Carbonate (OLC)
OLC has the potential to meaningfully improve the treatment burden for hyperphosphatemia patients with chronic kidney disease (CKD) on dialysis.
New Drug Application (NDA)
PDUFA
06/28/2025
06/28/2025
06/28/2025
11/14/2024
04:10 PM
NRXP)
NRx Pharmaceuticals, Inc.
PDUFA
NRX-101 (Oral D-Cycloserine/Lurasidone)
NRX-101 in treatment of bipolar depression in people akathisia or suicidality
New Drug Applications (NDA)
PDUFA
06/30/2025
06/30/2025
06/30/2025
12/30/2024
04:35 PM
VSTM
Verastem Oncology
PDUFA
Avutometinib + Defactinib
Avutometinib, an oral RAF/MEK clamp, in combination with Defactinib, an oral FAK inhibitor, for the treatment of adult patients with recurrent low-grade serous ovarian cancer (LGSOC), who received at least one prior systemic therapy and have a KRAS mutation.
