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Results For "approval"

2467 News Found

AstraZeneca Pharma India receives permission for paediatric drug
Drug Approval | September 26, 2021

AstraZeneca Pharma India receives permission for paediatric drug

It paves way for the launch of Selumetinib 10 mg & 25 mg capsule in India, subject to the receipt of related statutory approvals and licenses


U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations
Biotech | September 26, 2021

U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations

The company does not expect the outcome of this inspection to impact its plans


AstraZeneca to collaborate with VaxEquity for self-amplifying RNA therapy
Biotech | September 24, 2021

AstraZeneca to collaborate with VaxEquity for self-amplifying RNA therapy

saRNA is a new platform for the development of medicines and vaccines which uses similar technology to mRNA but with the added ability to self-amplify, thereby expressing proteins for longer, resulting in higher protein levels per dose level


Amaris Clinicals clears U.S. FDA audit
News | September 24, 2021

Amaris Clinicals clears U.S. FDA audit

The company is the Clinical Research Organisation of Caplin Point Laboratories


DCGI approves Ampio Pharma’s Phase II trials to tackle Covid-19 induced respiratory distress
Biotech | September 22, 2021

DCGI approves Ampio Pharma’s Phase II trials to tackle Covid-19 induced respiratory distress

Ampion is directly administered by inhalation and it allows the drug to directly target and attenuate inflammation in the lungs


Kotak Mahindra offers financing options for healthcare
News | September 22, 2021

Kotak Mahindra offers financing options for healthcare

The bank will provide a complete range of financing options including hospitals, labs, diagnostic centres and equipment manufacturers


U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar
Drug Approval | September 21, 2021

U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar

It becomes the first ophthalmology biosimilar to gain FDA approval in the United States


Zydus agrees to sell Mifegest and Cytolog to Integrace
News | September 21, 2021

Zydus agrees to sell Mifegest and Cytolog to Integrace

The purchaser is a part of the portfolio companies of PE firm True North. The said transaction is not a related party transaction.


CDSCO approves Exablate 4000 for patients living with Parkinson’s disease
Medical Device | September 20, 2021

CDSCO approves Exablate 4000 for patients living with Parkinson’s disease

The approval will enable the treatment of patients in India living with Essential tremor, tremor-dominant Parkinson's Disease and neuropathic pain


Imfinzi plus chemotherapy tripled patient survival at 3 years
Biotech | September 20, 2021

Imfinzi plus chemotherapy tripled patient survival at 3 years

The CASPIAN Phase III trial in extensive-stage small-cell lung cancer is the longest survival follow-up ever reported for immunotherapy treatment in this setting