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2731 News Found

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


Zydus Cadila receives final approval for Apremilast
Drug Approval | September 24, 2021

Zydus Cadila receives final approval for Apremilast

Zydus' Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy


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


Aurobindo subsidiary submits MAA for oncology biosimilar
Biotech | September 23, 2021

Aurobindo subsidiary submits MAA for oncology biosimilar

CuraTeQ Biologics is on track for filing a second oncology biosimilar


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


AYUSH minister Sonowal exhorts researchers to explore Indian traditional medicine
Policy | September 21, 2021

AYUSH minister Sonowal exhorts researchers to explore Indian traditional medicine

Assam is home to more than 1,700 species of medicinal plants


HUTCHMED initiates a Japan bridging study to Support Surufatinib
Biotech | September 21, 2021

HUTCHMED initiates a Japan bridging study to Support Surufatinib

Surufatinib is the third potential new medicine discovered by the company to enter into clinical development in Japan


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


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