Drug Approval | June 25, 2024
Lupin receives EIR from US FDA for its Somerset manufacturing facility
The facility was inspected from May 7 to May 17, 2024
The facility was inspected from May 7 to May 17, 2024
Glenmark's current portfolio consists of 197 products authorized for distribution in the U.S. marketplace
Abbott's first-of-its-kind i2i technology enables synchronized communication between two leadless pacemakers
According to IQVIATM sales data for the 12-month period ending March 2024, the Combigan Ophthalmic Solution, 0.2%|0.5% market achieved annual sales of approximately $290.0 million
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
Travoprost Ophthalmic Solution USP, 0.004%, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
GAAP net loss of $1.2 billion and GAAP diluted EPS of $(3.07)
Glenmark’s Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), will be distributed in the U.S. by Glenmark Therapeutics, USA
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
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