MHRA approves UK’s first new type of antibiotic for urinary tract infections

As with any medicine, the MHRA will keep the safety of gepotidacin under close review

AKUMS launches Aztreonam-Avibactam injection to combat multidrug-resistant infections

The product is manufactured at AKUMS’ state-of-the-art injectable facility in Kotdwar, Uttarakhand

Wockhardt’s breakthrough antibiotic Zaynich wins key regulatory nod in India

Alembic enters US branded market with first sales of Pivya UTI treatment

Pivya is Alembic’s first branded pharmaceutica product in the US and is being marketed through Alembic Therapeutics LLC

Venus Remedies secures marketing authorisation for Ceftazidime + Avibactam in Indonesia

Approval marks Venus Remedies’ first anti-infective marketing authorization in Indonesia and enables the country’s first generic entry for this critical antibiotic combination

Wockhardt’s WCK 5222 earns accelerated review from European Medicines Agency

The accelerated review covers WCK 5222 for multiple critical infections

MHRA clears inavolisib, offering new option for returning breast cancer

The oral, film-coated tablet is licensed for patients whose cancer has returned during or shortly after hormone therapy

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial

Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections

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

Alembic Pharmaceuticals acquires Utility Therapeutics for $12 million to strengthen US footprint

The acquisition of Pivya is an important step in Alembic’s ability to provide branded pharmaceutical product to the US Healthcare market