Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 80

Results For "NDA"

4743 News Found

Edwards Lifesciences’ SAPIEN M3 becomes first FDA-approved transseptal mitral valve replacement
Medical Device | December 27, 2025

Edwards Lifesciences’ SAPIEN M3 becomes first FDA-approved transseptal mitral valve replacement

The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is designed for patients with symptomatic moderate-to-severe or severe MR


FDA okays AQVESME as first treatment for anemia in alpha- & beta-thalassemia
News | December 27, 2025

FDA okays AQVESME as first treatment for anemia in alpha- & beta-thalassemia

The approval makes AQVESME the only FDA-approved therapy for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia


Sanofi to acquire Dynavax in $2.2 billion deal, bolstering adult vaccine portfolio
News | December 26, 2025

Sanofi to acquire Dynavax in $2.2 billion deal, bolstering adult vaccine portfolio

The move strengthens Sanofi’s presence in adult immunization by combining Dynavax’s innovative vaccines with Sanofi’s global scale and development capabilities


Japan nod to Dupixent for children with severe asthma
Drug Approval | December 26, 2025

Japan nod to Dupixent for children with severe asthma

The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies


Biofabri and Bharat Biotech ink tech transfer pact to boost global TB vaccine access
News | December 26, 2025

Biofabri and Bharat Biotech ink tech transfer pact to boost global TB vaccine access

BBIL will guarantee production and supply of MTBVAC to more than 70 countries across Africa and Southeast Asia


Cipla launches needle-free inhalable insulin Afrezza in India
News | December 26, 2025

Cipla launches needle-free inhalable insulin Afrezza in India

Afrezza comes in single-use cartridges, delivered via a simple inhaler device. Users select the appropriate cartridge, load it, inhale the insulin, and remove the cartridge


Lunit SCOPE matches pathologist accuracy in HER2 scoring for advanced biliary tract cancer
Clinical Trials | December 25, 2025

Lunit SCOPE matches pathologist accuracy in HER2 scoring for advanced biliary tract cancer

Study published in laboratory investigation, the official journal of the United States and Canadian Academy of Pathology


Niagen Bioscience secures full ownership of key NAD+ patents in major IP move
News | December 24, 2025

Niagen Bioscience secures full ownership of key NAD+ patents in major IP move

The portfolio includes foundational patents on the production, composition, and commercial use of NR


India's First: Curapod wearable gets Class II nod for drug-free musculoskeletal pain relief
Medical Device | December 24, 2025

India's First: Curapod wearable gets Class II nod for drug-free musculoskeletal pain relief

Provides pain relief for more than 30 conditions, including chronic back pain, arthritis, and sports injuries