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6319 News Found

FDA approves Sanofi’s BTK inhibitor for immune thrombocytopenia
Drug Approval | September 02, 2025

FDA approves Sanofi’s BTK inhibitor for immune thrombocytopenia

ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life


MHRA approves UK’s first new type of antibiotic for urinary tract infections
News | August 30, 2025

MHRA approves UK’s first new type of antibiotic for urinary tract infections

As with any medicine, the MHRA will keep the safety of gepotidacin under close review


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


CuraTeQ Biologics receives approval for biosimilar Dazublys from UK's MHRA
News | August 26, 2025

CuraTeQ Biologics receives approval for biosimilar Dazublys from UK's MHRA

Earlier in July 2025, Dazublys has received the marketing authorisation in the European Union from the European Commission


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


Boehringer and AnGes sign manufacturing agreement for HGF gene therapy product
Biotech | August 25, 2025

Boehringer and AnGes sign manufacturing agreement for HGF gene therapy product

Collaboration reinforces Boehringer Ingelheim’s expertise in microbial contract development and manufacturing


FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients
Drug Approval | August 18, 2025

FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients

Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo


STEER World achieves 200 kg/hr continuous granulation with patented INTEGRAAL system
News | August 17, 2025

STEER World achieves 200 kg/hr continuous granulation with patented INTEGRAAL system

The technology offers scalable continuous granulation at 200 kg/hour, with the potential to exceed 500 kg/hour for certain granules


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


Asian Institute of Nephrology & Urology expands hospital in Banjara Hills, Hyderabad
News | August 12, 2025

Asian Institute of Nephrology & Urology expands hospital in Banjara Hills, Hyderabad

AINU is set to accelerate its expansion footprint, enhance operational capabilities