Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 120

Results For "FDA"

2062 News Found

argenx reports positive phase 3 ADAPT SERON results of VYVGART in AChR-Ab seronegative gMG
News | August 28, 2025

argenx reports positive phase 3 ADAPT SERON results of VYVGART in AChR-Ab seronegative gMG

VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications


Indian pharma resilient to US tariffs; Eyes US pricing reform gains: Ind-Ra
Policy | August 27, 2025

Indian pharma resilient to US tariffs; Eyes US pricing reform gains: Ind-Ra

The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion


Dr. Reddy's launches novel drug for chronic constipation management
News | August 26, 2025

Dr. Reddy's launches novel drug for chronic constipation management

Dr. Reddy’s becomes the first pharmaceutical company to receive regulatory approval to launch Linaclotide in India under the brand name Colozo


Novo Nordisk's Wegovy approved in the US for the treatment of MASH
News | August 19, 2025

Novo Nordisk's Wegovy approved in the US for the treatment of MASH

The accelerated approval is supported by results from part 1 of the ESSENCE trial


Xspray Pharma licenses patent rights to Handa Therapeutics, secures royalty agreement
News | August 17, 2025

Xspray Pharma licenses patent rights to Handa Therapeutics, secures royalty agreement

Its lead product, Dasynoc, is awaiting FDA approval with a PDUFA date of October 7, 2025


Senores Pharmaceuticals acquires ANDAs from Teva Pharmaceuticals USA
News | August 13, 2025

Senores Pharmaceuticals acquires ANDAs from Teva Pharmaceuticals USA

The acquired ANDAs represent a market opportunity of about US$ 38 million in the USA


Zydus Lifesciences reports Q1 FY26 net profit at Rs. 1,466.8 Cr
News | August 13, 2025

Zydus Lifesciences reports Q1 FY26 net profit at Rs. 1,466.8 Cr

The company reported revenue from operations at Rs. 6,573.7 crore, up 6 per cent YoY


Briefs: Nectar Lifesciences, Cipla and Marksans Pharma
News | August 12, 2025

Briefs: Nectar Lifesciences, Cipla and Marksans Pharma

Marksans Pharma gets USFDA nod for acid reflux drug


Gland Pharma gets approval for Norepinephrine Bitartrate in 5% Dextrose injection bags
Drug Approval | August 12, 2025

Gland Pharma gets approval for Norepinephrine Bitartrate in 5% Dextrose injection bags

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Norepinephrine Bitartratein 5% Dextrose of Baxter Healthcare Corp