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Results For "approvaL"

2479 News Found

Lupin Q3 FY25 profit up 40% at Rs. 855 Cr
News | February 14, 2025

Lupin Q3 FY25 profit up 40% at Rs. 855 Cr

Revenue up 11% to Rs 5,768 crore as compared to Rs 5,197 crore


FDA approves Pfizer’s ADCETRIS combination regimen for the treatment of Relapsed/Refractory DLBCL
Drug Approval | February 13, 2025

FDA approves Pfizer’s ADCETRIS combination regimen for the treatment of Relapsed/Refractory DLBCL

Approval is based on positive data from the Phase 3 ECHELON-3 trial


FDA approves Roche’s Evrysdi tablet as first and only tablet for Spinal Muscular Atrophy
Drug Approval | February 13, 2025

FDA approves Roche’s Evrysdi tablet as first and only tablet for Spinal Muscular Atrophy

Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries


Briefs: Caplin Point Laboratories, Hikal and Cipla
Drug Approval | February 10, 2025

Briefs: Caplin Point Laboratories, Hikal and Cipla

Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru


Aurbindo Pharma posts Q3 FY25 profit at Rs. 846 Cr
News | February 08, 2025

Aurbindo Pharma posts Q3 FY25 profit at Rs. 846 Cr

During the quarter, US formulations revenue decreased by 2.3% YoY to Rs. 3,671 crore.


FDA approves EMBLAVEO for the treatment of adults with complicated intra-abdominal infections
News | February 08, 2025

FDA approves EMBLAVEO for the treatment of adults with complicated intra-abdominal infections

EMBLAVEOTM is the first and only monobactam/?-lactamase inhibitor combination antibiotic therapy approved by the USFDA


FDA approves Roche’s Susvimo as the first and only continuous delivery treatment diabetes-related blindness
Drug Approval | February 05, 2025

FDA approves Roche’s Susvimo as the first and only continuous delivery treatment diabetes-related blindness

Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME)


Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations
Drug Approval | February 03, 2025

Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations

The inspection was carried out from January 28 to February 1, 2025


CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA
News | February 03, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA

Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia


Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study
Clinical Trials | February 03, 2025

Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study

Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years