Drug Approval | August 28, 2024
Zydus receives USFDA final approval for Amantadine ER capsules 68.5 mg
Also received tentative approval for 137 mg
Also received tentative approval for 137 mg
The partnership will provide health plans with an out-of-the-box compliance solution for CMS-9115 and CMS-0057 rules
Ordspono is Regeneron’s first approved bispecific antibody and will provide an off-the-shelf option that can be administered in the out-patient setting, with hope for complete remission
Winrevair is the first activin signaling inhibitor therapy for PAH approved in Europe
Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL)
New analyses, including presentations on mavacamten, apixaban and milvexian, further solidify the company's strength and expertise as a leader in cardiovascular diseases
PfizerForAll works within the existing healthcare system and through a growing network of partners to simplify access via established channels and to close gaps in care
The initiation of a second Phase 3 clinical trial for bomedemstat demonstrates company’s commitment to advancing research in myeloproliferative neoplasms (MPNs)
Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India
Approval based on MIRACLE Phase III trial demonstrating a significant and clinically meaningful reduction in asthma exacerbations and improvement in asthma symptom control
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