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Results For "regulatory"

1225 News Found

10th Merck Bioforum India 2022 on Sept. 6-8
News | August 26, 2022

10th Merck Bioforum India 2022 on Sept. 6-8

This Bioforum will provide the latest insights on delivering increased speed, greater flexibility and enhanced quality while reducing the cost, and risks of navigating the evolving biopharma landscape


Eugia Pharma receives USFDA pproval for Medroxyprogesterone Acetate injectable suspension
Drug Approval | August 24, 2022

Eugia Pharma receives USFDA pproval for Medroxyprogesterone Acetate injectable suspension

The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA


Ascletis announces IND approval of Oral RdRp Inhibitor ASC10 for COVID-19 by China NMPA
Drug Approval | August 22, 2022

Ascletis announces IND approval of Oral RdRp Inhibitor ASC10 for COVID-19 by China NMPA

Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA


DCGI approves AstraZeneca 's Olaparib film-coated tablets
Drug Approval | August 20, 2022

DCGI approves AstraZeneca 's Olaparib film-coated tablets

Lynparza is the first and only approved PARPi targeting BRCA-mutated HER2-negative high-risk early breast cancer


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.


Jemincare inks licensing deal for prostate cancer drug with Roche
News | August 19, 2022

Jemincare inks licensing deal for prostate cancer drug with Roche

Genentech will be granted an exclusive license to develop and commercialize the degrader worldwide, and will be fully responsible for the development and commercialization costs.


Merck and Orna Therapeutics collaborate to advance Orna’s nextgen RNA technology
Biotech | August 17, 2022

Merck and Orna Therapeutics collaborate to advance Orna’s nextgen RNA technology

Collaboration supports multiple discovery efforts, including vaccines


NGL Fine-Chem planning greenfield expansion at Tarapur
News | August 16, 2022

NGL Fine-Chem planning greenfield expansion at Tarapur

The estimated capex is to the tune of Rs. 140 crore to be funded through debt and internal accrual


BeiGene announces strategic alliance with Ontada to improve US community oncology care
Public Health | August 16, 2022

BeiGene announces strategic alliance with Ontada to improve US community oncology care

Collaboration focuses on developing and implementing real-world research to drive patient access to cancer medicines


ENHERTU delays disease progression in DESTINYBreast02 Phase 3 Trial
Diagnostic Center | August 15, 2022

ENHERTU delays disease progression in DESTINYBreast02 Phase 3 Trial

Results consistent with previous trials, reinforcing benefit of Daiichi Sankyo and AstraZeneca’s ENHERTU in previously treated patients