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Results For "patient-safety"

101 News Found

FDA approves removal of REMS programs within Bristol Myers Squibb’s cell therapy labels
Drug Approval | June 28, 2025

FDA approves removal of REMS programs within Bristol Myers Squibb’s cell therapy labels

Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access


UK MHRA approves aumolertinib to treat non-small cell lung cancer
Drug Approval | June 05, 2025

UK MHRA approves aumolertinib to treat non-small cell lung cancer

Aumolertinib can be used in patients who have tested positive for a mutation in a gene called epidermal growth factor receptor


CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings
Clinical Trials | May 01, 2025

CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings

Phesgo label expansion delivers on patients’ preference for at-home administration and is an important step in freeing up cancer care capacity in clinical settings


Injection filter needle market to reach $1.73 billion in 2025
Opinion | April 17, 2025

Injection filter needle market to reach $1.73 billion in 2025

Rising demands and advancements in eye care drive growth


India reaffirms commitment to global pharmaceutical standardization and regulatory convergence: Anupriya Patel
Policy | February 06, 2025

India reaffirms commitment to global pharmaceutical standardization and regulatory convergence: Anupriya Patel

International Meeting of World Pharmacopoeias serves as a vital platform to foster international collaboration in pharmacopoeial science and regulatory harmonization


ZIM Laboratories and Neuraxpharm granted marketing authorization for Buprenorphine Sublingual Film in Europe
News | January 10, 2025

ZIM Laboratories and Neuraxpharm granted marketing authorization for Buprenorphine Sublingual Film in Europe

According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually


Yatharth Hospital becomes Uttar Pradesh's first JCI-accredited hospital
Healthcare | December 26, 2024

Yatharth Hospital becomes Uttar Pradesh's first JCI-accredited hospital

JCI accreditation is recognized globally


Granules India update on USFDA inspection at Gagillapur facility
News | December 05, 2024

Granules India update on USFDA inspection at Gagillapur facility

Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA


Aster and Blackstone-backed Quality Care to merge and create hospital chains in India
Healthcare | December 04, 2024

Aster and Blackstone-backed Quality Care to merge and create hospital chains in India

Aster DM Healthcare and Quality Care India Limited have signed definitive agreements to merge, subject to regulatory, corporate and shareholders’ approvals


NABH integrates FOGSI’S maternal health standards across its certification programs
News | November 15, 2024

NABH integrates FOGSI’S maternal health standards across its certification programs

The MoU signed in 2022 has progressed and culminated in the subsumption of FOGSI-led Manyata initiative’s 20 quality standards across NABH’s Certification programs