Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 54

Results For "ANDA"

2465 News Found

AB Science receives FDA and EMA authorization for phase 3 Trial of prostate cancer treatment
Clinical Trials | July 08, 2025

AB Science receives FDA and EMA authorization for phase 3 Trial of prostate cancer treatment

Masitinib is targeted at patients who are no longer responding to hormone-sensitive prostate cancer treatments


Veerhealth Care enters into contract manufacturing agreement
News | July 08, 2025

Veerhealth Care enters into contract manufacturing agreement

Commercial production is expected to begin soon


Imfinzi approved in the EU as first and only perioperative immunotherapy for muscle-invasive bladder cancer
Clinical Trials | July 06, 2025

Imfinzi approved in the EU as first and only perioperative immunotherapy for muscle-invasive bladder cancer

Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone


European Commission fines Alchem for participating in API cartel
News | July 05, 2025

European Commission fines Alchem for participating in API cartel

The companies admitted taking part in the cartel in exchange for reduced fines but Alchem did not settle


RedHill Biopharma initiates Expanded Phase 2 Study combining Opaganib and Darolutamide in advanced prostate cancer
Clinical Trials | July 03, 2025

RedHill Biopharma initiates Expanded Phase 2 Study combining Opaganib and Darolutamide in advanced prostate cancer

Opaganib has shown potential in enhancing ARPI treatment by blocking multiple enzymes involved in cancer cell survival.


AstraZeneca Pharma India receives permission to import Durvalumab Solution
News | July 02, 2025

AstraZeneca Pharma India receives permission to import Durvalumab Solution

Durvalumab in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy


INmune Bio reports core findings from Phase 2 trial in early Alzheimer’s disease
Clinical Trials | July 02, 2025

INmune Bio reports core findings from Phase 2 trial in early Alzheimer’s disease

Treatment with XPro was well-tolerated and safe, even in the high risk ApoE4+/+ patient group, and ARIA-E or ARIA-H was not observed in any patients


Glaukos receives EU MDR certification for iStent infinite
Medical Device | July 02, 2025

Glaukos receives EU MDR certification for iStent infinite

The iStent platform uses tiny surgical implants to lower eye pressure by restoring the eye’s natural fluid drainage system in patients with glaucoma


Moderna announces promising efficacy results from mRNA flu vaccine trial
Clinical Trials | July 01, 2025

Moderna announces promising efficacy results from mRNA flu vaccine trial

mRNA-1010 demonstrated superior relative vaccine efficacy