News | January 01, 2026
Wockhardt’s WCK 5222 earns accelerated review from European Medicines Agency
The accelerated review covers WCK 5222 for multiple critical infections
The accelerated review covers WCK 5222 for multiple critical infections
Adverse events were similar to placebo, and no AP-101-induced antibody responses were detected
The FDA’s review also revealed delays in Philips’ internal investigations, with 54 inquiries failing to meet targeted completion dates—23 of which were delayed by more than 100 days
Government policies and competitive industry driving India’s MedTech sector for sustained double-digit growth
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
The overall clinical efficacy of Zaynich across indications was 98% at the test-of-cure
A multi-disciplinary team of senior physicians opted to use Zidebactam/Cefepime under compassionate use
Stringent regulatory environments can make OEMs reluctant to change processes and materials for approved medical devices
The launch of Cefepime-Enmetazobactam marks a significant milestone for India's pharmaceutical industry in fight against AMR
DCGI has also granted permission to manufacture and market FDF of Cefepime and Enmetazobactam as a dry powder injectable
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