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4460 News Found

FDA approves VYALEV for adults living with advanced parkinson's disease
Drug Approval | October 18, 2024

FDA approves VYALEV for adults living with advanced parkinson's disease

VYALEV is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease


Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC
Drug Approval | October 16, 2024

Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC

Enhertu demonstrated clinically meaningful efficacy in previously treated patients


Akums Drugs enters into license and distribution agreement with Triple Hair, Canada
News | October 16, 2024

Akums Drugs enters into license and distribution agreement with Triple Hair, Canada

Akums Drugs will undertake this development and commercialization in India


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


USFDA approves Pfizer’s marstacimab-hncq for treatment of hemophilia A or B
Drug Approval | October 12, 2024

USFDA approves Pfizer’s marstacimab-hncq for treatment of hemophilia A or B

HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis


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


India’s emergence as a hub for affordable medicines is commendable: Dr. Jitendra Singh
News | October 10, 2024

India’s emergence as a hub for affordable medicines is commendable: Dr. Jitendra Singh

We now rank 3rd in pharmaceutical production by volume and 14th by value


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