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Results For "ANDA"

2123 News Found

Imfinzi approved in the US for the treatment of resectable non-small cell lung cancer
Drug Approval | August 17, 2024

Imfinzi approved in the US for the treatment of resectable non-small cell lung cancer

Based on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone


Fortis Hospital Mulund hosts India's first IFEM endorsed ECMO workshop for emergency medicine doctors
Healthcare | August 16, 2024

Fortis Hospital Mulund hosts India's first IFEM endorsed ECMO workshop for emergency medicine doctors

This two-day program was attended by 40 doctors & paramedical staff


Pfizer and BioNTech update on mRNA-based combination vaccine program against Influenza and Covid-19
News | August 16, 2024

Pfizer and BioNTech update on mRNA-based combination vaccine program against Influenza and Covid-19

In a Phase 3 trial, Pfizer and BioNTech’s combination vaccine candidate against influenza and COVID-19 met one of its two primary immunogenicity objectives


HCAH Kolkata Center achieves NABH Certification
News | August 15, 2024

HCAH Kolkata Center achieves NABH Certification

Becomes the first rehab & recovery center in east India to earn NABH accreditation


ICMR and Panacea Biotec initiates Phase III clinical trial of DengiAll
Diagnostic Center | August 15, 2024

ICMR and Panacea Biotec initiates Phase III clinical trial of DengiAll

The clinical trial will be conducted at 19 sites with 10,335 participants across India


Alembic receives USFDA final approval for Dabigatran Etexilate Capsules, 110 mg
Drug Approval | August 13, 2024

Alembic receives USFDA final approval for Dabigatran Etexilate Capsules, 110 mg

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals


Caplin Point announces completion of unannounced USFDA inspection
Drug Approval | August 11, 2024

Caplin Point announces completion of unannounced USFDA inspection

The inspection was concluded with zero observations


Caplin Point listed on Forbes Asia’s “200 Best under a Billion” for 2024
News | August 11, 2024

Caplin Point listed on Forbes Asia’s “200 Best under a Billion” for 2024

The comprehensive criteria encompasses evaluation of debt management, sales growth, earnings-per-share performance, as well as returns on equity


Zydus receives final approval from USFDA for Valbenazine Capsules
Drug Approval | August 11, 2024

Zydus receives final approval from USFDA for Valbenazine Capsules

Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)


Health Ministry launches 2nd phase of Mass Drug Administration Campaign 2024 to eliminate Lymphatic Filariasis
Policy | August 11, 2024

Health Ministry launches 2nd phase of Mass Drug Administration Campaign 2024 to eliminate Lymphatic Filariasis

The campaign targets 63 endemic districts across Bihar, Jharkhand, Karnataka, Odisha, Telangana, and Uttar Pradesh