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3151 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


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


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


Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3
Drug Approval | October 14, 2024

Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3

Indoco is comprehensively working on the remedial action plan


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


Akums launches dual action heartburn relief chewable tablet
News | October 12, 2024

Akums launches dual action heartburn relief chewable tablet

This product is categorized as antacids, antiflatulents and anti-Ulcerants


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


Zydus receives final approval from USFDA for Paliperidone ER Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg
Drug Approval | October 11, 2024

Zydus receives final approval from USFDA for Paliperidone ER Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg

Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad


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