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Pergoveris
Pergoveris for infertility treatment in assisted reproductive technology.
Teplizumab
Teplizumab for delaying progression to stage 3 type 1 diabetes.
DB-OTO
DB-OTO for otoferlin-related congenital hearing loss.
RMC-6236
RMC-6236 for RAS-mutant pancreatic and other solid tumors.
Bitopertin
Bitopertin for erythropoietic protoporphyria.
Ketamine
Ketamine injectable product prioritized for domestic manufacturing resilience and hospital supply.
Bedaquiline
Bedaquiline pediatric formulation for pulmonary multidrug-resistant tuberculosis in young children.
Dostarlimab
Dostarlimab for mismatch repair-deficient locally advanced rectal cancer.
Casgevy
Casgevy for sickle cell disease.
Orforglipron
Orforglipron for obesity.
Wegovy
Wegovy for obesity.
Enlicitide decanoate
Enlicitide decanoate for hypercholesterolemia.
Sacituzumab Tirumotecan
Sacituzumab tirumotecan for advanced or metastatic EGFR-mutant nonsquamous non-small cell lung cancer.
INQOVI
FDA decision on INQOVI plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy
Sotyktu
FDA decision on Sotyktu for the treatment of adults with active psoriatic arthritis
New formulation of F18
FDA decision on new formulation of F18 PSMA-targeted PET imaging agent to determine the presence or absence of PSMA positive lesions in prostate cancer
Reproxalap
FDA decision on Reproxalap for the treatment of dry eye disease
IMCIVREE
FDA decision on expanded use of IMCIVREE for the treatment of acquired hypothalamic obesity
Linerixibat
FDA decision on Linerixibat for the treatment of cholestatic pruritus in patients with Primary Biliary Cholangitis
KRESLADI
FDA decision on KRESLADI for the treatment of for severe Leukocyte Adhesion Deficiency-I
LNTH-2501 (Ga 68 edotreotide)
FDA decision on LNTH-2501 for use with PET imaging for localization of somatostatin receptor-positive neuroendocrine tumors
Tividenofusp alfa
FDA decision on Tividenofusp alfa for the treatment of Hunter syndrome
PADCEV
FDA decision on PADCEV plus KEYTRUDA for patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy
KEYTRUDA
FDA decision on KEYTRUDA plus Padcev for the treatment of patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy
Opdivo
FDA decision on Opdivo plus Chemotherapy combination for previously untreated Stage III or IV Classical Hodgkin Lymphoma
Cenegermin-bkbj
Intranasal cenegermin-bkbj for nonarteritic anterior ischemic optic neuropathy.
Cytisinicline
Cytisinicline for smoking cessation.
Upcoming Decisions
| PDUFA | Drug | Type | Ticker | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
~12/15 | Pergoveris | CNPV | — | Pending | — | — | — | — | — | — | — | — | — | — |
Pergoveris for infertility treatment in assisted reproductive technology. | ||||||||||||||
~12/15 | Teplizumab | CNPV | $SNY | Pending | — | — | — | — | — | — | — | — | — | — |
Teplizumab for delaying progression to stage 3 type 1 diabetes. | ||||||||||||||
~12/15 | DB-OTO | CNPV | $REGN | Pending | — | — | — | — | — | — | — | — | — | — |
DB-OTO for otoferlin-related congenital hearing loss. | ||||||||||||||
~12/15 | RMC-6236 | CNPV | $RVMD | Pending | — | — | — | — | — | — | — | — | — | — |
RMC-6236 for RAS-mutant pancreatic and other solid tumors. | ||||||||||||||
~12/15 | Bitopertin | CNPV | $IRON | Pending | — | — | — | — | — | — | — | — | — | — |
Bitopertin for erythropoietic protoporphyria. | ||||||||||||||