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4735 News Found

U.S. FDA concludes inspection of Lupin’s Goa facility with seven observations
News | September 20, 2021

U.S. FDA concludes inspection of Lupin’s Goa facility with seven observations

The company said in a regulatory filing that it was confident of addressing the observations satisfactorily


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


Novartis’ Kisqali data indicates longest median survival in advanced breast cancer
Drug Approval | September 20, 2021

Novartis’ Kisqali data indicates longest median survival in advanced breast cancer

With the MONALEESA-2 final analysis, only Kisqali has reported statistically significant overall survival (OS) benefit with an aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in the first-line (1L) setting


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


India to resume export of Covid-19 vaccines from October
Policy | September 20, 2021

India to resume export of Covid-19 vaccines from October

The country’s vaccine production has more than doubled since April and is set to touch 300 million doses next month


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


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


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


QCI institutes Prof. SK Joshi laboratory excellence award
News | September 17, 2021

QCI institutes Prof. SK Joshi laboratory excellence award

This award is open to all currently operational laboratories pertaining to testing, calibration & medical including their proficiency testing providers & reference material producers located in India


Cosara Diagnostics receives CDSCO licence to manufacture Dengue test kit
Medical Device | September 17, 2021

Cosara Diagnostics receives CDSCO licence to manufacture Dengue test kit

It tests for the presence or absence of ribonucleic acid (RNA) of Dengue (Type 1, 2 4) in serum or plasma from patients suspected of dengue viral infection.