The table below is a review of notable updates that occurred in October 2022 for investigational products in development (not an inclusive list). Click on the status link to view our full coverage.
| Drug | Pharmacologic Class | Proposed Indication | Status |
| Allergic Disorders | |||
| Neffy (epinephrine nasal spray; Silverback Therapeutics) | Sympathomimetic | For the emergency treatment of allergic reactions (type 1), including anaphylaxis in adults and children weighing at least 30kg. | NDA accepted for review |
| Cardiovascular Disorders | |||
| Camzyos (mavacamten; Bristol Myers Squibb) | Selective allosteric inhibitor of cardiac myosin | To reduce the need for septal reduction therapy in patients with obstructive hypertrophic cardiomyopathy. | sNDA accepted for review |
| Hematological Disorders | |||
| Takhzyro (lanadelumab-flyo; Takeda) | Plasma kallikrein inhibitor | For prophylaxis to prevent attacks of hereditary angioedema in pediatric patients 2 to less than 12 years of age. | sBLA accepted for Priority Review |
| Valoctocogene roxaparvovec (BioMarin Pharmaceutical) | Adeno-associated virus (AAV) gene therapy | Treatment of hemophilia A in adults. | Resubmitted BLA accepted for review |
| Infectious Diseases | |||
| SER-109 (Seres Therapeutics) | Oral microbiome therapeutic containing purified bacterial spores of Firmicute species obtained from the stool of healthy human donors | Treatment of recurrent Clostridioides difficile infection. | BLA accepted for Priority Review |
| Kidney Disease | |||
| Daprodustat (GlaxoSmithKline) | Hypoxia-inducible factor prolyl hydroxylase inhibitor | Treatment of patients with anemia of chronic kidney disease. | FDA panel voted |
| Sparsentan (Travere Therapeutics) | Dual endothelin angiotensin receptor antagonist | Treatment of immunoglobulin A nephropathy. | NDA review period extended |
| Metabolic Disorders | |||
| Alvelestat (MPH-966; Mereo BioPharma) | Neutrophil elastase inhibitor | Treatment of patients with alpha-1 antitrypsin deficiency-associated lung disease. | Fast Track designation |
| Neurologic Disorders | |||
| SPN-830 (apomorphine infusion device; Supernus Pharmaceuticals) | Non-ergoline dopamine agonist | Continuous treatment of motor fluctuations (off episodes) in adults with Parkinson disease. | Complete Response Letter issued |
| Telitacicept (RemeGen Co., Ltd) | Recombinant TACI-Fc (transmembrane activator and calcium modulator and cyclophilin ligand interactor) fusion protein | Treatment of myasthenia gravis. | Orphan Drug designation |
| Tofersen (Biogen) | Antisense medicine to reduce the production of SOD1 protein | Treatment of superoxide dismutase 1 amyotrophic lateral sclerosis. | NDA review period extended |
| Oncology | |||
| Sapanisertib (Calithera Biosciences) | Dual mTORC 1/2 inhibitor | Treatment of adults with unresectable or metastatic squamous non-small cell lung cancer (sqNSCLC) whose tumors have a mutation in nuclear factor erythroid 2-related factor (NRF2) and who have received prior platinum-based chemotherapy and immune checkpoint inhibitor therapy. | Fast Track designation |
| Trodelvy (sacituzumab govitecan-hziy; Gilead Sciences) | Trop-2-directed antibody and topoisomerase inhibitor conjugate | Treatment of adults with unresectable locally advanced or metastatic hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting. | sBLA accepted for Priority Review |
| Ophthalmic Disorders | |||
| Eylea (aflibercept; Regeneron Pharmaceuticals) | Vascular endothelial growth factor inhibitor | Treatment of retinopathy of prematurity in preterm infants. | sBLA accepted for Priority Review |
| CyclASol (cyclosporine ophthalmic solution; Novaliq) | Anti-inflammatory and selective immunomodulatory drug | Treatment of the signs and symptoms of dry eye disease. | NDA accepted for review |
| Pain Management | |||
| Basimglurant (NOE-101; Noema Pharma) | Metabotropic glutamate receptor 5 inhibitor | Management of pain associated with trigeminal neuralgia. | Fast Track designation |
