Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 111

Results For "FDA"

2063 News Found

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


Praxis Precision hits milestone in fight against rare paediatric seizures
Clinical Trials | December 08, 2025

Praxis Precision hits milestone in fight against rare paediatric seizures

The EMBOLD study evaluated relutrigine for patients with SCN2A and SCN8A developmental and epileptic encephalopathies


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


Zydus receives EIR for the injectable facility located at Jarod
Drug Approval | December 04, 2025

Zydus receives EIR for the injectable facility located at Jarod

This inspection was conducted following the warning letter issued by the USFDA


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


Bristol Myers to extend key trial of Cobenfy in Alzheimer’s psychosis
Clinical Trials | December 04, 2025

Bristol Myers to extend key trial of Cobenfy in Alzheimer’s psychosis

The company is excluding data from the affected sites to maintain the study's integrity


US District Court grants summary judgement in Favour of SPARC for Sezaby PRV
News | December 03, 2025

US District Court grants summary judgement in Favour of SPARC for Sezaby PRV

FDA's withholding of the PRV was contrary to law because no drug product containing phenobarbital sodium was 'previously approved'


Citius Oncology's new therapy offers new hope for cutaneous T-cell lymphoma patients
News | December 03, 2025

Citius Oncology's new therapy offers new hope for cutaneous T-cell lymphoma patients

LYMPHIR addresses a clear clinical need in a disease with limited treatment options


Merck unveils first human data for Alzheimer’s candidates
Clinical Trials | December 03, 2025

Merck unveils first human data for Alzheimer’s candidates

The company also revealed that MK-2214 has received Fast Track Designation from the U.S. Food and Drug Administration