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
Doxycycline Capsules, 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
The agreement licenses the company to launch in the United States, in February 2025, once approved by the U.S. FDA
The U.S. FDA recently approved Xolair as the first and only medicine for children and adults with one or more food allergies
Survodutide has potential to become best-in-class treatment for metabolic dysfunction-associated steatohepatitis
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