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Results For "US-FDA"

296 News Found

Venus Remedies secures final Rs. 11 crore payment from Cipla for AMR drug
News | December 09, 2025

Venus Remedies secures final Rs. 11 crore payment from Cipla for AMR drug

The patented product, developed by Venus Medicine Research Centre (VMRC) for the treatment of multidrug-resistant (MDR) infections, was sold to Cipla in 2019


Pfizer’s therapy scores major win in Phase 3 trial for Hemophilia patients with inhibitors
Clinical Trials | December 08, 2025

Pfizer’s therapy scores major win in Phase 3 trial for Hemophilia patients with inhibitors

HYMPAVZI’s safety profile was generally favorable


Bengaluru healthtech firm Biomoneta secures USFDA nod for air purifier
Healthcare | December 08, 2025

Bengaluru healthtech firm Biomoneta secures USFDA nod for air purifier

Captured microbes are then neutralized on engineered microbicidal surfaces


Briefs: IOL Chemicals & Pharmaceuticals, Ipca Laboratories and Anuh Pharma
News | December 06, 2025

Briefs: IOL Chemicals & Pharmaceuticals, Ipca Laboratories and Anuh Pharma

Ipca Laboratories receives three observations from USFDA for API facility at Tarapur


Roche launches first rapid point-of-care test for whooping cough
News | December 04, 2025

Roche launches first rapid point-of-care test for whooping cough

The PCR-based test, delivered via Roche’s cobas liat system, allows results to be obtained during a patient consultation in GP practices and Emergency Rooms


FDA nod to priority review to AstraZeneca’s Baxdrostat for hard-to-control hypertension
Drug Approval | December 04, 2025

FDA nod to priority review to AstraZeneca’s Baxdrostat for hard-to-control hypertension

Here's a development that aims to keep your blood pressure in check. Literally!


Cleveland Diagnostics’ IsoPSA test for prostate cancer detection gains FDA approval
News | December 03, 2025

Cleveland Diagnostics’ IsoPSA test for prostate cancer detection gains FDA approval

Now a test that offers new precision in prostate cancer detection


FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich
Drug Approval | December 02, 2025

FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich

This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA


a2z wins FDA nod for groundbreaking abdomen-pelvis CT AI Triage system
News | November 30, 2025

a2z wins FDA nod for groundbreaking abdomen-pelvis CT AI Triage system

Abdomen-pelvis CT is the nation’s highest-volume CT category


SMS Pharmaceutical's associate company receives FDA approval for reformulated Ranitidine
Drug Approval | November 27, 2025

SMS Pharmaceutical's associate company receives FDA approval for reformulated Ranitidine

The approval by the US FDA comes after extensive safety testing and manufacturing improvements