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3781 News Found

FDA setback for Sanofi’s Tolebrutinib in progressive MS
Drug Approval | December 27, 2025

FDA setback for Sanofi’s Tolebrutinib in progressive MS

Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity


EU nod to Wayrilz as breakthrough treatment for hard-to-treat ITP
Drug Approval | December 27, 2025

EU nod to Wayrilz as breakthrough treatment for hard-to-treat ITP

Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation


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


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


Abbott’s Volt PFA System gets FDA nod
News | December 24, 2025

Abbott’s Volt PFA System gets FDA nod

AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life


FDA nod to Boehringer Ingelheim’s JASCAYD for progressive pulmonary fibrosis in adults
Drug Approval | December 24, 2025

FDA nod to Boehringer Ingelheim’s JASCAYD for progressive pulmonary fibrosis in adults

The study found that nerandomilast effectively slowed lung function decline in patients, with discontinuation rates similar to placebo


Gilead licenses Assembly Bio's investigational Herpes drugs after positive phase 1b data
Clinical Trials | December 24, 2025

Gilead licenses Assembly Bio's investigational Herpes drugs after positive phase 1b data

Under the 2023 collaboration agreement, Assembly Bio will receive $35 million for Gilead’s exercise of the HSV program option


Hansa Biopharma submits FDA application for kidney transplant desensitization treatment
News | December 24, 2025

Hansa Biopharma submits FDA application for kidney transplant desensitization treatment

If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant