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3648 News Found

CDSCO, NRAI meets WHO international standards for vaccine regulations
Policy | October 14, 2024

CDSCO, NRAI meets WHO international standards for vaccine regulations

India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI


Indian drug regulator recommends Wockhardt's Miqnaf for treatment of CABP
News | October 14, 2024

Indian drug regulator recommends Wockhardt's Miqnaf for treatment of CABP

Wockhardt's yet another novel antibiotic Miqnaf receives favourable recommendation from Subject Expert Committee of CDSCO


Zydus and ICMR initiate a Phase 2 trial of Desidustat in patients with Sickle Cell Disease
News | October 14, 2024

Zydus and ICMR initiate a Phase 2 trial of Desidustat in patients with Sickle Cell Disease

The partnership marks a pivotal step towards developing new therapies for combating Sickle Cell Disease


AGC Biologics begins operations at new manufacturing building in Copenhagen
News | October 14, 2024

AGC Biologics begins operations at new manufacturing building in Copenhagen

The new facility uses the latest mammalian systems and single-use technology, including a production line with eight 2,000 L bioreactors


Alkem enters into licensing agreement with BioTherapeutics
News | October 11, 2024

Alkem enters into licensing agreement with BioTherapeutics

Under the licensing agreement, Alkem will carry out the clinical development of “SON-080” in India with support from Sonnet and enable global and India regulatory filings


FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation
Drug Approval | October 11, 2024

FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation

Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting


Aurigene Oncology gets positive results of Phase 1 study for CAR-T cell therapy for multiple myeloma
Clinical Trials | October 09, 2024

Aurigene Oncology gets positive results of Phase 1 study for CAR-T cell therapy for multiple myeloma

India’s first trial for a novel autologous BCMA directed CAR-T cell therapy in patients with relapsed / refractory multiple myeloma


DKSH partners with R-Biomeds to bring oncology and thyroid treatments to Cambodia
Supply Chain | October 09, 2024

DKSH partners with R-Biomeds to bring oncology and thyroid treatments to Cambodia

DKSH has entered into an exclusive partnership with R-Biomeds to bring the necessary medication to patients in Cambodia


Aster implements India’s first IOeRT for cancer care
Healthcare | October 09, 2024

Aster implements India’s first IOeRT for cancer care

To set a new standard in oncology, offering highly targeted radiation therapy that improves treatment precision, and accelerates recovery for cancer patients


FDA grants fast track designation to Wockhardt's novel antibiotic WCK 6777
Drug Approval | October 08, 2024

FDA grants fast track designation to Wockhardt's novel antibiotic WCK 6777

WCK 6777 is the only once-a-day drug in global antibiotic pipeline designed for outpatient parenteral antimicrobial therapy