Merck has shared these additional analyses with the FDA and they will be presented to the FDA’s Antimicrobial Drugs Advisory Committee on Nov. 30th
Fyarro is the first and only approved therapy for adults for the treatment of malignant PEComa in adults
The approval is for Cytomegalovirus, a type of Herpes virus
Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU
Jardiance is the first SGLT2-inhibitor therapy to prove reduction in risk of cardiovascular death in people with type-II diabetes and established cardiovascular disease
The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
Dabigatran Etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)
The company is moving towards complex and more differentiated products
Theradaptive's regenerative implants are best-in-class and are designed to permit precise tissue regeneration for a variety of tissue types and clinical indications
It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years
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