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3472 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


Strides Pharma's CDMO arm OneSource raises Rs. 801 crore in pre-listing round
News | October 16, 2024

Strides Pharma's CDMO arm OneSource raises Rs. 801 crore in pre-listing round

The share subscription agreements are being executed at a pre-money equity value of US$ 1.65 billion


Wockhardt files fast-acting Insulin Aspart injection with DCGI
News | October 16, 2024

Wockhardt files fast-acting Insulin Aspart injection with DCGI

The market size of Aspart in India is currently estimated over Rs. 260 crore with only 2 players


Lyka’s patent pending Drug Pregabalin Gel 8% w/w receives approval from CDSCO
Drug Approval | October 15, 2024

Lyka’s patent pending Drug Pregabalin Gel 8% w/w receives approval from CDSCO

Lyka has received the CDSCO approval for manufacturing and marketing of Pregabalin Gel 8% w/w


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


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


OneSource unveils new brand identity at CPHI Milan
News | October 11, 2024

OneSource unveils new brand identity at CPHI Milan

Aims to achieve CDMO sales of US$ 400 million by 2028


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