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1428 News Found

Pfizer withdraws all lots of sickle cell disease treatment voxelotor
News | September 26, 2024

Pfizer withdraws all lots of sickle cell disease treatment voxelotor

Pfizer's decision is based on the totality of clinical data


Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19
News | September 23, 2024

Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19

Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization


Shilpa Biologicals appoints Dr. Sridevi Khambhampaty as CEO
People | September 20, 2024

Shilpa Biologicals appoints Dr. Sridevi Khambhampaty as CEO

She brings an overall Techno Commercial experience of 22+ Years in various Organizations


FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy
Drug Approval | September 16, 2024

FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy

Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous


USFDA concludes audit for Laurus Labs’ API manufacturing facility at Hyderabad with zero Form 483 observations
Drug Approval | September 14, 2024

USFDA concludes audit for Laurus Labs’ API manufacturing facility at Hyderabad with zero Form 483 observations

The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices


GPCB issues directive for closure of Tatva Chintan Pharma Chem Ankleshwar plant
Policy | September 14, 2024

GPCB issues directive for closure of Tatva Chintan Pharma Chem Ankleshwar plant

GPCB has also asked to submit a bank guarantee of Rs. 2, 00,000 for compliance assurance at the time of revocation and has also ordered to deposit interim environment damage compensation amount


Zydus announces licensing and supply agreement for two Gadolinium based MRI injectable
News | September 14, 2024

Zydus announces licensing and supply agreement for two Gadolinium based MRI injectable

Both the products are Gadolinium based Magnetic Resonance Imaging (MRI) contrast agents and will be the first set of contrast agent products in Zydus’ injectable portfolio for the US market


USFDA determines inspection classification of VAI for the contract manufacturing facility at Spokane, Washington
Drug Approval | September 11, 2024

USFDA determines inspection classification of VAI for the contract manufacturing facility at Spokane, Washington

Jubilant HollisterStier is a subsidiary of Jubilant Pharma Holding


Zydus Lifesciences announces completion of Phase II(a) clinical trial of Usnoflast
Clinical Trials | September 11, 2024

Zydus Lifesciences announces completion of Phase II(a) clinical trial of Usnoflast

ALS patients experience neuroinflammation and rapid neurodegeneration


Merck announces positive top-line results from Phase 3 trial evaluating efficacy and safety of Gardsil 9
Clinical Trials | September 11, 2024

Merck announces positive top-line results from Phase 3 trial evaluating efficacy and safety of Gardsil 9

The trial met its primary and secondary endpoints demonstrating that administration of a 3-dose regimen of GARDASIL 9