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Results For "approval"

2604 News Found

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


Roche receives positive CHMP opinion for Gavreto
Drug Approval | September 18, 2021

Roche receives positive CHMP opinion for Gavreto

If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC


BMS receives positive CHMP opinion for Opdivo
Drug Approval | September 18, 2021

BMS receives positive CHMP opinion for Opdivo

The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy


Zydus Cadila receives final nod for anti-depressant
Drug Approval | September 18, 2021

Zydus Cadila receives final nod for anti-depressant

The medicine helps restore the balance of certain natural substances (serotonin) in the brain