Top Ten US-FDA Approved Pharmacological Agents in 2023: A Year in Review MDTV Bureau30 Dec 2023 3:51 PM ISTWe come to the end of 2023. Here are top ten pharmacological agents that received US-FDA approval throughout this year, across key therapy areas:1)...
Submit safety, efficacy data of Indian Patients: CDSCO Panel Tells AstraZeneca on additional indication of Enhertu 100mg Dr. Divya Colin29 Dec 2023 6:15 PM ISTNew Delhi: In response to the drug major AstraZeneca's proposal for the additional indication of Trastuzumab Deruxtecan Powder Concentrate Solution...
Biological E Gets CDSCO Panel Nod to study safety of XBB 1.5-RBD Subunit Covid-19 Vaccine in 5-80 years old Dr. Divya Colin28 Dec 2023 6:00 PM ISTNew Delhi: The drug major Biological E has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Zydus Healthcare gets Rs 284.58 crore income tax demand notice Ruchika Sharma27 Dec 2023 3:29 PM ISTThe demand is determined due to "apparent mistakes while processing its return of income', it said.
CDSCO Drug Alert: 64 Drug Samples Including Aristo's Monocef 500 Flagged Susmita Roy26 Dec 2023 3:53 PM ISTNew Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has flagged 62...
AstraZeneca Gets CDSCO Panel Nod for Enhertu 100mg for additional indication of breast cancer Dr. Divya Colin25 Dec 2023 6:00 PM ISTNew Delhi: Noting an unmet medical need in the country, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Revise BE study Protocol: CDSCO Panel Tells Akum Pharma on Chlorthalidone, Cilnidipine, Bisoprolol FDC Dr. Divya Colin24 Dec 2023 6:00 PM ISTNew Delhi: Citing that individual and innovators products should be taken as a reference product in the proposed bioequivalence (BE) study protocol,...
GSK Gets CDSCO Panel Nod to study safety of anti-cancer drug Dostarlimab Dr. Divya Colin23 Dec 2023 6:00 PM ISTNew Delhi: Citing that the total number of evaluable patients in the study should be a minimum of 30, the Subject Expert Committee (SEC) functional...
Conduct bioequivalence study: CDSCO Panel tells Zydus Healthcare on Glycopyrrolate, Indacaterol Metered dose inhalation Dr. Divya Colin22 Dec 2023 6:00 PM ISTNew Delhi: Rejecting the clinical trial waiver proposal, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO bans use of Chlorpheniramine Maleate IP 2mg and Phenylephrine HCL IP 5mg drop/ml FDC in kids below 4 years Ruchika Sharma21 Dec 2023 2:19 PM ISTNew Delhi: To ensure the safety of infants and young children in the country, the Central Drugs Standard Control Organization (CDSCO) has...
JB Pharma enters Opthalmology space, signs Rs 1,089 crore deal with Novartis for 10 brands Ruchika Sharma20 Dec 2023 11:14 AM ISTNew Delhi: JB Chemicals & Pharmaceuticals Ltd (JB Pharma) has announced that the Company has inked a trade mark licence agreement along with...
Conduct BE study and clinical trial: CDSCO Panel tells Cipla on Formoterol Fumarate Dihydrate, glycopyrronium inhaler Dr. Divya Colin19 Dec 2023 6:58 PM ISTNew Delhi: Rejecting the proposal for clinical trial and bioequivalence (BE) study waiver presented by drug major Cipla, the Subject Expert Committee...
