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3982 News Found

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection
Drug Approval | October 05, 2025

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial


FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer
Drug Approval | October 05, 2025

FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study


BMS’s anti-MTBR-Tau granted fast track designation by FDA for Alzheimer’s disease
Drug Approval | October 05, 2025

BMS’s anti-MTBR-Tau granted fast track designation by FDA for Alzheimer’s disease

Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of disease


Amgen’s Phase III data supports FDA label expansion of Repatha
News | October 05, 2025

Amgen’s Phase III data supports FDA label expansion of Repatha

Repatha is now the first and only PCSK9 inhibitor to demonstrate significant reduction of cardiovascular events as both primary and secondary prevention


AstraZeneca Pharma India receives sale, distribution approval from CDSCO for Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder
News | October 04, 2025

AstraZeneca Pharma India receives sale, distribution approval from CDSCO for Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder

Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder for concentrate for solution for infusion is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors


Novartis to launch DTP platform for Cosentyx in US
Supply Chain | October 01, 2025

Novartis to launch DTP platform for Cosentyx in US

Through the new DTP platform, Novartis will make Cosentyx available to patients at a price that reflects the average savings typically retained by insurers and pharmacy benefit managers


Lupin receives FDA approval Rivaroxaban for oral suspension
Drug Approval | October 01, 2025

Lupin receives FDA approval Rivaroxaban for oral suspension

The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India


Pfizer agrees to slash prescription drug prices for Americans
News | October 01, 2025

Pfizer agrees to slash prescription drug prices for Americans

Pfizer will participate in TrumpRx.gov, a direct-to-patient purchasing platform offering discount up to 85%


AbbVie seeks FDA approval for Pivekimab Sunirine to treat rare, aggressive blood cancer
Drug Approval | October 01, 2025

AbbVie seeks FDA approval for Pivekimab Sunirine to treat rare, aggressive blood cancer

BPDCN is a challenging blood cancer with characteristics of both leukemia and lymphoma