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Results For "regulator"

2056 News Found

Alkem Laboratories receives 7 observations following US FDA inspection at Daman facility
Drug Approval | May 04, 2026

Alkem Laboratories receives 7 observations following US FDA inspection at Daman facility

The US regulator conducted an inspection at the Amaliya manufacturing plant between April 20 and May 1, 2026


FDA advisory panel backs AstraZeneca prostate cancer combo in decisive vote
News | May 04, 2026

FDA advisory panel backs AstraZeneca prostate cancer combo in decisive vote

The Committee backed the combination based on results from the CAPItello-281 Phase III trial, marking a key milestone in the regulatory pathway for AstraZeneca’s targeted therapy strategy in prostate cancer


Axithra appoints Lars Kongsbak as CEO ahead of clinical validation and Series A fundraise
People | May 04, 2026

Axithra appoints Lars Kongsbak as CEO ahead of clinical validation and Series A fundraise

Precision medicine company advances Raman spectroscopy-based therapeutic drug monitoring platform for rapid, patient-specific dosing solutions


Aurobindo arm CuraTeQ receives Health Canada approval for bevacizumab biosimilar Bevqolva
Drug Approval | May 04, 2026

Aurobindo arm CuraTeQ receives Health Canada approval for bevacizumab biosimilar Bevqolva

Notice of Compliance from Health Canada enables marketing authorisation for cancer biosimilar in Canadian market


Moderna posts Q1 2026 loss despite revenue surge
News | May 04, 2026

Moderna posts Q1 2026 loss despite revenue surge

Growth was supported by stronger COVID vaccine sales and expanded government supply agreements in international markets


OneSource Specialty Pharma's partners get Health Canada approval for generic Semaglutide injection
News | May 04, 2026

OneSource Specialty Pharma's partners get Health Canada approval for generic Semaglutide injection

Approval for generic Ozempic® in Canada strengthens OneSource’s global CDMO footprint in complex peptide injectable manufacturing


Sankara Eye Hospital hosts ‘CSSD 360’ workshop on sterilisation and patient safety
Hospitals | May 04, 2026

Sankara Eye Hospital hosts ‘CSSD 360’ workshop on sterilisation and patient safety

Workshop focused on strengthening sterile processing standards, infection prevention, and CSSD best practices in healthcare settings


ten23 health successfully tests West Synchrony S1 PFS system on fill-finish lines
News | May 04, 2026

ten23 health successfully tests West Synchrony S1 PFS system on fill-finish lines

Early implementation of West Synchrony S1 platform aims to accelerate biologics and vaccine development while reducing manufacturing risk for biopharma partners


Wockhardt reports FY26 net profit of Rs 317 crore, Board approves fundraising plan
Biopharma | May 04, 2026

Wockhardt reports FY26 net profit of Rs 317 crore, Board approves fundraising plan

Compared to a net loss of Rs 12 crore in FY25, the pharma major reported a consolidated turnaround in its financial performance


Lilly posts explosive Q1 2026 results
News | May 04, 2026

Lilly posts explosive Q1 2026 results

Lifts full-year outlook as obesity drug boom accelerates