Drug Approval | October 05, 2025
Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial
This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company
The conference stressed a multi-dimensional approach required to address Antimicrobial Resistance (AMR), focusing on the right approach and strengthening awareness
The products include high-quality, advanced anti-infective formulations such as EMROK (Levonadifloxacin) and MIQNAF (Nafithromycin)
The PLI scheme focuses on incentivizing a strategic shift towards high-value, innovative products such as biologics, complex generics, and specialty formulations
Reinforcing commitment to ethical and sustainable growth
This case report is jointly authored by US clinicians from leading hospitals, Houston Methodist Hospital, Weill Cornell Medical College and Johns Hopkins
The Medical Countermeasures Strategy focuses on strengthening the EU’s preparedness for health crises
The acquisition of Pivya is an important step in Alembic’s ability to provide branded pharmaceutical product to the US Healthcare market
This global affiliation marks a critical step in the company’s mission to create long-term value through ethical practices, scientific innovation, and inclusive healthcare delivery
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