Regulatory Approval not required for retrospective analysis of Inotuzumab ozogamicin: CDSCO panel Tells Pfizer Dr. Divya Colin15 May 2023 6:00 PM ISTNew Delhi: In response to the drug major Pfizer's proposal to conduct the retrospective and non-interventional study of the anticancer drug...
Submit Animal Toxicity Data: CDSCO panel Tells Dr. Reddy's on Ferric carboxymaltose injection Dr. Divya Colin14 May 2023 6:00 PM ISTNew Delhi: In response to the drug major Dr. Reddy's Laboratories' proposal to manufacture and market the Ferric Carboxymaltose Injection, the Subject...
NPPA Fixes Ceiling Price Of 5 Scheduled Formulations, Details Dr. Divya Colin13 May 2023 6:00 PM ISTNew Delhi: Through a recent notification, the National Pharmaceutical Pricing Authority (NPPA) has fixed the ceiling price of 5 scheduled formulations...
Submit serious adverse events, deaths occurred during CT: CDSCO Panel Tells Novartis on Ruxolitinib Dr. Divya Colin12 May 2023 6:00 PM ISTNew Delhi: With respect to the safety and efficacy data of global study and post-marketing data related to the Ruxolitinib tablets 5mg,10mg, 15mg, and...
NPPA fixes and revises ceiling prices of 15 scheduled formulations, details Dr. Divya Colin11 May 2023 6:00 PM ISTNew Delhi: Through a recent notification, the National Pharmaceutical Pricing Authority (NPPA) has fixed and revised the ceiling price of 15 scheduled...
NPPA Fixes Retail Price of 15 Formulation, Detail Dr. Divya Colin10 May 2023 6:00 PM ISTNew Delhi: Through a recent notification, the National Pharmaceuticals Pricing Authority (NPPA) has fixed the retail of 15 scheduled formulations...
Cipla, JB Chemicals dragged to court for alleged infringement of Vifor FCM patent Farhat Nasim9 May 2023 5:00 PM ISTNew Delhi: Cipla Ltd and J B Chemicals and Pharmaceuticals have been embroiled in a court case as Swiss drug firm Vifor International moves Delhi High...
Novo Nordisk Gets CDSCO Panel Nod to study recombinant coagulation factor XIII, Novothirteen Dr. Divya Colin8 May 2023 6:00 PM ISTNew Delhi: Pharmaceutical major, Novo Nordisk has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Drug Safety Alert: Indian Pharmacopoeia Commission Flags ADR Linked To Ziprasidone Susmita Roy7 May 2023 6:00 PM ISTNew Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of April, has revealed that an...
Zydus Healthcare Gets CDSCO Panel To Study Dydrogesterone Extended-release Tablets Dr. Divya Colin6 May 2023 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Zydus...
Conduct BE and Phase III CT: CDSCO Panel Tells Alkem On Elagolix Tablets Dr. Divya Colin5 May 2023 6:00 PM ISTNew Delhi: In response to the drug major Alkem Laboratories' proposal to manufacture and market the GnRH receptor antagonist Elagolix, the Subject...
Emcure Pharmaceuticals Gets CDSCO To Manufacture & Market the FDC Antiviral Drug Dr. Divya Colin4 May 2023 6:00 PM ISTNew Delhi: Granting approval for bioequivalence (BE) study and clinical trial (CT) study waiver, the Subject Expert Committee (SEC) functional under...
