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Results For "regulatory"

1139 News Found

Alembic Pharmaceuticals completes USFDA RRA for its bioequivalence facility
News | August 29, 2022

Alembic Pharmaceuticals completes USFDA RRA for its bioequivalence facility

The RRA was conducted from 22nd August, 2022 to 26th August, 2022.


Qdenga approved in Indonesia for use regardless of prior dengue exposure
Drug Approval | August 28, 2022

Qdenga approved in Indonesia for use regardless of prior dengue exposure

Indonesia national agency for drug and food control, BPOM, approved QDENGA for use in individuals 6 to 45 years of age


Jubilant receives EIR from USFDA for its radiopharmaceuticals manufacturing facility Montreal Canada
News | August 27, 2022

Jubilant receives EIR from USFDA for its radiopharmaceuticals manufacturing facility Montreal Canada

With the receipt of the EIR, the inspection stands successfully closed.


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.


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.