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FDA approves sBLA for Takeda's Vonvendi for Von Willebrand disease
Drug Approval | September 08, 2025

FDA approves sBLA for Takeda's Vonvendi for Von Willebrand disease

Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD


Zydus Lifesciences appoints Nitin Parekh as President (Special Projects)
People | September 08, 2025

Zydus Lifesciences appoints Nitin Parekh as President (Special Projects)

He has been associated with the Zydus Group since 2009


USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility
Drug Approval | September 08, 2025

USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility

Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe


Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity
Drug Approval | September 04, 2025

Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity

This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity


Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA
Drug Approval | September 04, 2025

Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA

Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure


Merck appoints David Weinreich as new Global Head of R&D and CMO for Healthcare Business
People | September 03, 2025

Merck appoints David Weinreich as new Global Head of R&D and CMO for Healthcare Business

He has successfully led the development of 15 approved drugs worldwide across various therapeutic areas over his more than 20-year career


Eli Lilly appoints Dr. Vivek Jha as Senior Director – Commercial Strategy, AI & Transformation
People | September 03, 2025

Eli Lilly appoints Dr. Vivek Jha as Senior Director – Commercial Strategy, AI & Transformation

He will be leading the design and execution of transformative strategies that harness the power of AI and automation, drive process optimization, and ignite digital innovation


FDA grants accelerated approval to Zongertinib for HER2-mutated non-squamous NSCLC
Drug Approval | September 03, 2025

FDA grants accelerated approval to Zongertinib for HER2-mutated non-squamous NSCLC

New targeted therapy offers hope for patients with unresectable or metastatic NSCLC harboring HER2 tyrosine kinase domain activating mutations


FDA approves Lecanemab autoinjector, marking first at-home treatment for Alzheimer disease
Drug Approval | September 02, 2025

FDA approves Lecanemab autoinjector, marking first at-home treatment for Alzheimer disease

The new subcutaneous autoinjector for lecanemab offers a self-administered, at-home treatment option for early-stage Alzheimer's disease