The table below is a review of notable updates that occurred in December 2022 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.
| Drug | Pharmacologic Class | Proposed Indication | Status |
| Cardiovascular Disease | |||
| Omecamtiv mecarbil (Cytokinetics) | Selective small molecule cardiac myosin activator | Treatment of heart failure with reduced ejection failure. | FDA panel voted |
| Dermatological Disorders | |||
| Bimekizumab (UCB) | Humanized monoclonal IgG1 antibody that inhibits IL-17A and IL-17F | Treatment of adults with moderate to severe plaque psoriasis. | Resubmitted BLA accepted for review |
| Gastrohepatic Disorders | |||
| Etrasimod (Pfizer) | Oral selective sphingosine 1-phosphate receptor modulator | Treatment of patients with moderately to severely active ulcerative colitis. | NDA accepted for review |
| Immunization | |||
| mRNA-based combination vaccine (Pfizer and BioNTech) | modRNA-based influenza vaccine candidate + Omicron-adapted bivalent COVID-19 vaccine | For the prevention of influenza and COVID-19 with a single injection. | Fast Track designation |
| Pentavalent meningococcal vaccine (MenABCWY; Pfizer) | Meningococcal vaccine candidate | For the prevention of invasive meningococcal disease caused by serogroups A, B, C, W and Y in individuals 10 through 25 years of age. | BLA accepted for review |
| RSVpreF (PF-06928316; Pfizer) | Bivalent RSV vaccine candidate | For the prevention of lower respiratory tract disease caused by RSV in adults 60 years of age and older. | BLA accepted for Priority Review |
| Infectious Diseases | |||
| Olorofim (F2G Inc.) | Orotomides – new class of antifungal agents targeting the de novo pyrimidine biosynthesis pathway. | Treatment of invasive fungal infections in patients who have limited or no treatment options. | NDA accepted |
| Metabolic Disorders | |||
| Bitopertin (Disc Medicine) | Glycine transporter 1 inhibitor | Treatment of erythropoietic protoporphyria. | Orphan Drug designation |
| Pegunigalsidase alfa (Protalix BioTherapeutics and Chiesi Global Rare Diseases) | Long-acting recombinant, PEGylated, cross-linked α-galactosidase-A investigational product candidate | Treatment of adults with Fabry disease. | Orphan Drug designation |
| Oncology | |||
| Omburtamab (Y-mAbs) | Radiolabeled monoclonal antibody targeting tumor cells that express B7-H3 | Treatment of CNS/leptomeningeal metastasis from neuroblastoma. | Complete Response Letter issued |
| WP1122 (Moleculin) | Prodrug of 2-DG targeting glycolysis and glycosylation | Treatment of glioblastoma multiforme. | Fast Track designation |
| ZB131 (ZielBio) | Monoclonal antibody targeting cancer-specific plectin | Treatment of pancreatic cancer. | Fast Track designation |
| Ophthalmic Disorders | |||
| ADX-2191 (methotrexate injection; Aldeyra Therapeutics) | DMARD (folic acid antagonist). Intravitreal formulation designation to be vitreous-compatible. | Treatment of primary vitreoretinal lymphoma. | NDA submitted |
| Poisoning & Drug Dependence | |||
| Brixadi (buprenorphine extended-release injection; Braeburn) | Opioid (partial agonist-antagonist) | Weekly and monthly subcutaneous injection for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. | Resubmitted NDA accepted for review |
| Narcan (OTC naloxone HCI nasal spray; Emergent BioSolutions) | Opioid antagonist that reverses the effects of opioids | For the OTC emergency treatment for opioid overdose. | sNDA accepted for Priority Review |
| RiVive (OTC naloxone HCI nasal spray; Harm Reduction Therapeutics) | Opioid antagonist that reverses the effects of opioids | For the OTC emergency treatment for opioid overdose. | NDA accepted for Priority Review |
| Psychiatric Disorders | |||
| PH10 (pherine nasal spray; Vistagen) | Binds to peripheral chemosensory neurons in nasal passages to regulate the olfactory-amygdala neural circuits | Treatment of major depressive disorder. | Fast Track designation |
