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Results For "Medicines-and-Healthcare-Products-Regulatory-Agency"

49 News Found

Lupin announces successful completion of UK MHRA inspection of Pithampur facilities
Drug Approval | March 27, 2023

Lupin announces successful completion of UK MHRA inspection of Pithampur facilities

With the combination of oral solid, inhalation, dermatology, high potent and oral contraceptive products, this is an important facility of the company


Syngene Q3FY23 revenue reaches Rs. 803 Cr; PAT reaches Rs. 110 Cr
News | January 24, 2023

Syngene Q3FY23 revenue reaches Rs. 803 Cr; PAT reaches Rs. 110 Cr

The company is pleased to report positive performances from all divisions this quarter. Growth in our research divisions, Discovery Services and the Dedicated Centres was solid


Lupin receives UK MHRA Approval of Lutio for treatment of COPD
Drug Approval | August 27, 2022

Lupin receives UK MHRA Approval of Lutio for treatment of COPD

Lutio has the potential to offer significant cost savings when available to UK patients.


Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022
Drug Approval | August 20, 2022

Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022

Therapy recently approved in Canada under the brand name KORSUVA


Tavneos recommended by England’s NICE for the treatment of AAV
Drug Approval | August 19, 2022

Tavneos recommended by England’s NICE for the treatment of AAV

The decision follows authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.


Propanc Biopharma undertaking PRP manufacturing & development for human use
Biotech | May 20, 2022

Propanc Biopharma undertaking PRP manufacturing & development for human use

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection


Myovant Sciences and Accord Healthcare partner to commercialise Orgovyx in Europe
Biotech | May 10, 2022

Myovant Sciences and Accord Healthcare partner to commercialise Orgovyx in Europe

Myovant to receive an upfront payment of US $50 million, is eligible to receive commercial launch, sales-based and other milestones totaling up to US $90.5 million


Pharming gets positive review from UK MHRA for leniolisib
Biotech | April 26, 2022

Pharming gets positive review from UK MHRA for leniolisib

A Promising Innovative Medicine (PIM) designation is an early indication that leniolisib is a candidate for the MHRA's Early Access to Medicines Scheme


EU approves Evusheld to prevent Covid-19
Drug Approval | March 28, 2022

EU approves Evusheld to prevent Covid-19

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months


Evusheld recommended for market authorisation in EU
Biotech | March 25, 2022

Evusheld recommended for market authorisation in EU

Recommendation based on Phase III PROVENT trial showing a significant reduction in the risk of developing symptomatic COVID-19, with protection lasting at least six months