ALPHA Phase III trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris improved haemoglobin levels and reduced anaemia and fatigue
Mirabegron Extended-Release Tablets, 25 mg had estimated annual sales of US$ 1,019 million in the US
NexGard Spectra is a soft, flavourful monthly chew that kills fleas before they can lay eggs
Breakthrough Therapy designation for pain associated with DPN granted by FDA
Thermo Fisher has equipped this Centre for Innovation with state-of-the-art platforms such as CellInsight CX7 LZR Pro High Content Screening Platform
Biocon will undertake the development, manufacturing and supply of the drug product, and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazilian market
FDA has concluded that this inspection is 'closed'
Submission based on results from pivotal phase III trial showing all primary endpoints met
Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers
US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024
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