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Results For "US-FDA"

451 News Found

Roche unveils major upgrade to cobas 6800/8800 systems, boosting lab efficiency
Digitisation | December 19, 2025

Roche unveils major upgrade to cobas 6800/8800 systems, boosting lab efficiency

The update promises to revolutionize laboratory workflows by optimizing resources


FDA nod to Johnson & Johnson’s AKEEGA for aggressive prostate cancer
Drug Approval | December 18, 2025

FDA nod to Johnson & Johnson’s AKEEGA for aggressive prostate cancer

Patients with BRCA mutations often face aggressive disease and poor prognosis


Lupin receives EIR from USFDA for Nagpur injectable facility
Drug Approval | December 17, 2025

Lupin receives EIR from USFDA for Nagpur injectable facility

The EIR was issued following an inspection of the facility from September 8 to September 16, 2025


Apitoria Pharma receives 3 observations from USFDA for Unit-V
Drug Approval | December 12, 2025

Apitoria Pharma receives 3 observations from USFDA for Unit-V

The company will respond to the US FDA within the stipulated timelines


GSK’s experimental lung cancer drug gains FDA orphan drug status
Drug Approval | December 12, 2025

GSK’s experimental lung cancer drug gains FDA orphan drug status

GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization


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