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Results For "regulatory"

1216 News Found

Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone
Biotech | October 21, 2021

Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone

Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD


Biocon Biologics’ interchangeable biosimilar insulin Glargine preferred on Express Scripts
News | October 21, 2021

Biocon Biologics’ interchangeable biosimilar insulin Glargine preferred on Express Scripts

Express Scripts, a leading pharmacy benefit management organization, will list Viatris labelled biosimilar insulin Glargine as a preferred insulin brand on its National Preferred Formulary (NPF)


Domestic growth to the fore as US weakness persists: ICICI Direct
News | October 19, 2021

Domestic growth to the fore as US weakness persists: ICICI Direct

ICICI Direct gives an update on the 12 companies that it has covered in the healthcare universe. A report


Dr Reddy’s Labs announces U.S. FDA approval for Lenalidomide capsules
Drug Approval | October 19, 2021

Dr Reddy’s Labs announces U.S. FDA approval for Lenalidomide capsules

The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg


AstraZeneca ties up with Rajiv Gandhi Cancer Institute to treat patients with Chronic Lymphocytic Leukemia
Healthcare | October 19, 2021

AstraZeneca ties up with Rajiv Gandhi Cancer Institute to treat patients with Chronic Lymphocytic Leukemia

Rajiv Gandhi Cancer Institute (RGCI), Delhi one of Asia’s premier institutes becomes the first strategic partner to adopt and implement Project Chariot in patients across North India & Delhi NCR region


Ipsen enters exclusive worldwide tie-up with Accent for its pre-clinical R&D oncology pipeline
Biotech | October 18, 2021

Ipsen enters exclusive worldwide tie-up with Accent for its pre-clinical R&D oncology pipeline

Ipsen obtains an exclusive license to develop, manufacture and commercialize a pre-clinical stage METTL3-inhibitor programme


Metropolis Healthcare board approves acquisition of Hitech for Rs 636 crore
Diagnostic Center | October 16, 2021

Metropolis Healthcare board approves acquisition of Hitech for Rs 636 crore

The revised deal involves a cash consideration only as against the earlier proposal of cash and equity


Shilpa Medicare raises over Rs. 297 crore through preferential allotment
News | October 15, 2021

Shilpa Medicare raises over Rs. 297 crore through preferential allotment

Equity raise to finance growth and investments in the biological space


Exelixis in-licenses second anti-cancer compound from Aurigene
Biotech | October 15, 2021

Exelixis in-licenses second anti-cancer compound from Aurigene

U.S. FDA has accepted the investigational new drug application for phase 1 clinical trial in non-Hodgkin’s lymphoma


Lonza to expand development services for mammalian products in Singapore
Biotech | October 13, 2021

Lonza to expand development services for mammalian products in Singapore

This expansion will support the global operations network and help meet global demand for mammalian development services that support Lonza’s manufacturing sites