Original New Drug Application Approvals by US FDA (16-31 December 2025)
06 Jan 2026
New drug applications approved by US FDA as of 16-31 December 2025 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
MYQORZO
MYQORZO
- Active Ingredient(s): Aficamten
- Strength: 5MG; 10MG; 15MG; 20MG
- Dosage Form(s) / Route(s): Tablet;oral
- Company: Cytokinetics
- Approval Date: 19 December 2025
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.
- Approved Label: 19 December 2025 (PDF)
- Active Ingredient(s): Nerandomilast
- Strength: 9MG; 18MG
- Dosage Form(s) / Route(s): Tablet;oral
- Company: Boehringer Ingelheim
- Approval Date: 19 December 2025
- Submission Classification: NA
- Indication(s): Indicated for:
- The treatment of idiopathic pulmonary fibrosis in adult patients.
- The treatment of progressive pulmonary fibrosis in adult patients.
- Approved Label: 19 December 2025 (PDF)
- Active Ingredient(s): Semaglutide
- Strength: 1.5MG; 4MG; 9MG; 25MG
- Dosage Form(s) / Route(s): Tablet
- Company: Novo Nordisk Inc
- Approval Date: 22 December 2025
- Submission Classification: Type 3 - New Dosage Form
- Indication(s): Indicated in combination with a reduced calorie diet and increased physical activity:
- To reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight.
- To reduce excess body weight and maintain weight reduction long term in:
- Adults and pediatric patients aged 12 years and older with obesity.
- Adults with overweight in the presence of at least one weightrelated comorbid condition.
- For the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults. This indication is approved under accelerated approval based on improvement of MASH and fibrosis. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial.
- To reduce the risk of major adverse CV events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight.
- To reduce excess body weight and maintain weight reduction long term in adults with obesity, or in adults with overweight in the presence of at least one weight-related comorbid condition.
- Concomitant use of WEGOVY (semaglutide) tablets or WEGOVY (semaglutide) injection with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended.
- Approved Label: 22 December 2025 (PDF)
WEGOVY tablets are indicated in combination with a reduced calorie diet and increased physical activity:
Limitations of Use:
