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
Global Phase-3 study initiation expected in the second half of 2024
Ajovy confirms efficacy in new Phase 3 data significantly reducing the number of migraine days per month
ABRYSVO met its trial primary endpoints in adults aged 18 to 59 with an increased respiratory syncytial virus (RSV) disease risk.
The period from 2020 to 2022 witnessed a remarkable surge in deal worth
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