The validations confirm the completion of the applications and commence the scientific review process
LEO Pharma is developing delgocitinib cream for the treatment of moderate to severe chronic hand eczema, a hard-to-treat disease where there is a high unmet medical need for treatment
This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology
CuraTeQ Biologics is on track for filing a second oncology biosimilar
Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes
Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years
Nadda chairs Joint Strategy Meeting with Line Ministries for TB Mukt Bharat Abhiyan- 100-Day Intensified Campaign
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID?19 in an immunocompromised patient population
Acquisition of exclusive commercialization rights for European markets
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