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646 News Found

Bayer announces positive topline resukts for Aflibercept 8 mg in phase III study
Clinical Trials | December 17, 2024

Bayer announces positive topline resukts for Aflibercept 8 mg in phase III study

Demonstrates vision gains with extended treatment intervals in retinal vein occlusion


Briefs: Alembic Pharmaceuticals and Veerhealth Care
Drug Approval | December 12, 2024

Briefs: Alembic Pharmaceuticals and Veerhealth Care

The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market


Supriya Lifescience expands global footprint with Esketamine Hydrochloride approval
News | December 09, 2024

Supriya Lifescience expands global footprint with Esketamine Hydrochloride approval

Esketamine hydrochloride is a vital drug to be used for treating mental illness and is likely to significantly impact the LATAM market


FDA accepts supplemental Biologics License Application for Roche’s Columvi combination
Drug Approval | December 06, 2024

FDA accepts supplemental Biologics License Application for Roche’s Columvi combination

For people with relapsed or refractory diffuse large B-cell lymphoma


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


Merck announces pivotal phase 3 ZENITH trial evaluating WINREVAIR
News | November 26, 2024

Merck announces pivotal phase 3 ZENITH trial evaluating WINREVAIR

WINREVAIR met primary endpoint of time to first morbidity or mortality event for the treatment of patients with pulmonary arterial hypertension (PAH) functional class III or IV at high risk of mortality


USFDA accepts Blenrep combinations for treatment of relapsed/refractory multiple myeloma
Drug Approval | November 25, 2024

USFDA accepts Blenrep combinations for treatment of relapsed/refractory multiple myeloma

If approved, Blenrep (belantamab mafodotin) in combinations with BorDex (BVd) and PomDex (BPd) could redefine multiple myeloma treatment at or after first relapse


MRP of anti-cancer drugs to come down due to custom duty exemption and GST rate reduction
Policy | October 30, 2024

MRP of anti-cancer drugs to come down due to custom duty exemption and GST rate reduction

This is in pursuance to the announcement made in the Union Budget for the year 2024-25 exempting these three anti-cancer medicines from customs duty


Calquence granted priority review in US for patients with untreated mantle cell lymphoma
Drug Approval | October 06, 2024

Calquence granted priority review in US for patients with untreated mantle cell lymphoma

Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy


USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia
Drug Approval | September 30, 2024

USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia

The inspection concluded with the issuance of a form 483 with five observations