CDSCO issues alert on Baxter Blood Purification Device Hemoperfusion Cartridge Dr. Divya Colin30 July 2022 6:00 PM ISTNew Delhi: In suspecting the presence of particulate matter, Central Drug Standard Control Organization (CDSCO) has issued medical devices alert on...
Novartis Phase III CT protocol for Lanalumab Rejected by CDSCO Panel Dr. Divya Colin29 July 2022 6:00 PM ISTNew Delhi: Citing that the clinical trial protocol missed some inclusion/exclusion criteria, the Subject Expert Committee (SEC) functional under...
ICMR invites bids from pharma companies for development of Monkeypox vaccine Ruchika Sharma28 July 2022 5:09 PM ISTNew Delhi: The National Institute of Virology (NIV) in Pune under ICMR has isolated the monkeypox virus from the clinical specimen of a patient which...
Zydus Life Desidustat gets CDSCO panel nod to treat Anaemia in Kidney Patients Dr. Divya Colin27 July 2022 6:00 PM ISTNew Delhi: In a significant development, Zydus Life has received approval from the Subject Expert Committee (SEC) functional under the Central Drug...
No relief to medical device makers: Health Minister declines to relax last date for registration of medical devices Ruchika Sharma26 July 2022 1:20 PM ISTAs per the rules, unregistered devices will not be deemed authorised and manufacturers may face penal action, an official source said.
Intas Pharma Gets CDSCO Panel Okay To Study Human Normal Immunoglobulin Dr. Divya Colin25 July 2022 6:00 PM ISTNew Delhi: Pharmaceutical major Intas Pharma has got the go-head from the Subject Expert Committee (SEC) functional under Central Drug Standard...
Class A, Class B non notified medical devices must enter licencing regime effective on October 10, 2022 Dr. Divya Colin24 July 2022 12:52 PM ISTNew Delhi: Referring the previous notification No. G.S.R. 102(E) dated 11.02.2020, the Government of India, the Director-General of Health Services,...
AstraZeneca Olaparib gets CDSCO Panel okay for BRCA mutated HER2 negative breast cancer Dr. Divya Colin23 July 2022 6:00 PM ISTNew Delhi: Based on the scientific data provided by the drug maker AstraZeneca, the Subject Expert Committee (SEC) functional under Central Drug...
Novartis Ruxolitinib Gets CDSCO Panel Okay for Acute and Chronic Graft Versus Host Disease Dr. Divya Colin22 July 2022 6:00 PM ISTNew Delhi: In response to the pharma major Novartis proposal for additional indication of Ruxolitinib Tablets 5/10/15/20 mg, the Subject Expert...
Merck Keytruda fails in head and neck cancer trial Ruchika Sharma21 July 2022 2:30 PM ISTKEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and...
CDSCO panel rejects Optimus Pharma Phase III CT protocol of Tofacitinib Ointment for androgenic alopecia Dr. Divya Colin20 July 2022 6:00 PM ISTNew Delhi: Citing that there is no scientific rationality data and supportive published literature, the Subject Expert Committee (SEC) functional...
Sanofi gets CDSCO Panel okay to study Dupilumab Dr. Divya Colin19 July 2022 6:00 PM ISTNew Delhi: Directing to include all Serious Adverse Events (SAEs) and adverse events (AEs) of test drug in the informed consent document, the Subject...
