U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024
Outlook 2024 remains flat CER sales growth and CORE EBITDA margin of high 20s
Dexamethasone Tablets USP, 1 mg had annual sales of US$ 1.8 mn in the United States (IQVIA MAT March 24)
Lupin updates on shipment of Mirabegron ER Tablets
Sevelamer Carbonate Tablets approval consolidates the company's position in the Sevelamer segment
Receives 3 final and 2 tentative product approvals thus far in Q1FY25
The company is committed to address this observation comprehensively within stipulated time
The product is used to treat amyotrophic lateral sclerosis
Cellectis is also eligible to receive an investigational new drug (IND) option fee and development
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