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Results For "regulatory"

1215 News Found

European Commission grants market authorisation for BioMarin’s Voxzogo
Biotech | August 28, 2021

European Commission grants market authorisation for BioMarin’s Voxzogo

It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo


Indoco’s AnaCipher receives UK-MHRA accreditation
Drug Approval | August 27, 2021

Indoco’s AnaCipher receives UK-MHRA accreditation

The clinical research organisation located in Hyderabad is a USFDA inspected facility


Pharma continues to attract PE investments: Care Ratings
News | August 27, 2021

Pharma continues to attract PE investments: Care Ratings

In H1FY21, it attracted PE deals worth US $ 1.6 billion compared to US $ 3 billion in CY2020


Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose
Drug Approval | August 26, 2021

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose

The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks


Wockhardt and Jemincare partner for novel respiratory antibiotic Nafithromycin
Drug Approval | August 26, 2021

Wockhardt and Jemincare partner for novel respiratory antibiotic Nafithromycin

The company to receive upfront and milestone payments, in addition to royalties


Cipla forms JV with Kemwell Biopharma
News | August 25, 2021

Cipla forms JV with Kemwell Biopharma

The agreement is to develop, manufacture and commercialise biosimilars for the global market.


CRISIL positive on Krishna Institute of Medical Sciences
News | August 25, 2021

CRISIL positive on Krishna Institute of Medical Sciences

CRISIL Ratings has revised its outlook on the long term ratings of Krishna Institute Of Medical Sciences Limited (KIMS) to 'Positive' from 'Stable' while reaffirming the ratings at 'CRISIL AA-/CRISIL A1+'


Pfizer to acquire Trillium Therapeutics
Biotech | August 24, 2021

Pfizer to acquire Trillium Therapeutics

Trillium’s portfolio includes biologics that are designed to enhance the ability of patients’ innate immune system to detect and destroy cancer cells


Lupin launches Luforbec to treat asthma & COPD in UK
News | August 24, 2021

Lupin launches Luforbec to treat asthma & COPD in UK

It is the first branded generic alternative to Fostair 100/6 pMDI


DBT-BIRAC supported India’s first m-RNA vaccine gets nod for Phase II/III trial
Biotech | August 24, 2021

DBT-BIRAC supported India’s first m-RNA vaccine gets nod for Phase II/III trial

CDSCO gives the green signal as HGCO19 was safe, tolerable and immunogenic in the participants of the study