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Results For "approval"

2612 News Found

Zydus Cadila receives final approval for Mesalamine extended-release capsules
Drug Approval | August 16, 2021

Zydus Cadila receives final approval for Mesalamine extended-release capsules

The group has a total of 320 ANDA approvals


Bharat Biotech’s first nasal vaccine gets approval for Phase 2 trials
Biotech | August 14, 2021

Bharat Biotech’s first nasal vaccine gets approval for Phase 2 trials

This is the first of its kind vaccine for Covid 19 to get the go-ahead


Unichem Labs receive ANDA approval for Metformin Hydrochloride
News | August 13, 2021

Unichem Labs receive ANDA approval for Metformin Hydrochloride

It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus


Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%
Drug Approval | August 12, 2021

Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%

It’s an AB-rated generic therapeutic version of Durezol


Biocon Biologics and Viatris receive approval for first interchangeable biosimilar Semglee
Drug Approval | August 12, 2021

Biocon Biologics and Viatris receive approval for first interchangeable biosimilar Semglee

The company is eligible for 12 months exclusivity from launch


Penpulimab Monoclonal Antibody (PD-1) Obtains Marketing Approval in China
Biotech | August 11, 2021

Penpulimab Monoclonal Antibody (PD-1) Obtains Marketing Approval in China

The approval is based on a multi-centre, single-arm, open-label pivotal clinical trial


GW Pharmaceuticals receives approval for Epidyolex to treat seizures
Drug Approval | August 11, 2021

GW Pharmaceuticals receives approval for Epidyolex to treat seizures

TSC causes epilepsy in up to 85 % of patients, and up to 60 % of those patients do not respond to standard anti-seizure medicines


Pillar Biosciences Receives Premarket Approval from FDA for its oncoReveal Dx Lung and Colon Cancer Assay
Drug Approval | August 10, 2021

Pillar Biosciences Receives Premarket Approval from FDA for its oncoReveal Dx Lung and Colon Cancer Assay

The product can be used by any lab that conducts NGS testing, making precision medicine accessible to all cancer patients


Covaxin receives approval from Hungary
Biotech | August 05, 2021

Covaxin receives approval from Hungary

More countries recognise Covaxin


Zydus Cadila receives approval from USFDA for Fulvestrant Injection
News | July 31, 2021

Zydus Cadila receives approval from USFDA for Fulvestrant Injection

The group now has 320 approvals and has so far filed over 400 ANDAs