Generate safety and efficacy data: CDSCO Tells Glenmark Over Glimipride, Lobeglitazone FDC Dr. Divya Colin13 Nov 2023 3:30 PM ISTNew Delhi: In response to the proposal presented by the drug major Glenmark Pharmaceuticals to conduct the Phase IV clinical trial of the fixed-dose...
Conduct Phase III clinical trial: CDSCO to Zydus Healthcare over FDC Empagliflozin plus Sitagliptin Dr. Divya Colin12 Nov 2023 4:00 PM ISTNew Delhi: In response to the proposal presented by the drug major Zydus Healthcare, the Subject Expert Committee ( SEC) functional under the Central...
NPPA revises ceiling price of 438 scheduled formulation, Bare Metal Stents, details Dr. Divya Colin11 Nov 2023 4:00 PM ISTNew Delhi: In accordance with the price revision as per the annual wholesale price index (WPI) increase of 12.1218%, through a recent notification,...
FIRST: Takeda gets USFDA nod for Adzybm for rare inherited Blood Clotting Disorder Ruchika Sharma10 Nov 2023 11:39 AM ISTOsaka: Takeda has announced that the U.S. Food and Drug Administration (FDA) has approved ADZYNMA (ADAMTS13, recombinant-krhn) for the...
Novo Nordisk to discontinue long-acting insulin Levemir in US Ruchika Sharma9 Nov 2023 5:30 PM IST"Novo Nordisk will phase out, then permanently discontinue Levemir in the U.S. on December 31, 2024," the company said in a statement.
Revise Phase IV CT: CDSCO panel tells Bharat Biotech over Typhoid (Vi Capsular Polysaccharide) Tetanus Toxoid Conjugate Vaccine Dr. Divya Colin8 Nov 2023 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has directed the vaccine maker...
Sun Pharma gets CDSCO nod to manufacture, market FDC Silodosin JP plus Tadalafil Dr. Divya Colin7 Nov 2023 5:30 PM ISTNew Delhi: Based on the Phase III Clinical trial (CT) of the Fixed Dose Combination (FDC) Silodosin JP plus Tadalafil presented by the drug major Sun...
Cadila's Cholecalciferol Aqueous Injection 6,00,000 IU/2ml exempted from price control: NPPA Susmita Roy5 Nov 2023 5:30 PM ISTNew Delhi: Noting that Cadila Pharmaceutical's formulation "Cholecalciferol Aqueous Injection 6,00,000 IU/2ml (Vitamin D3 Injection)" was duly...
Submit raw data linked to CT result: CDSCO Panel Tells Akum Pharma on Azelnidipine, Metoprolol FDC drug Dr. Divya Colin4 Nov 2023 5:26 PM ISTNew Delhi: Based on the justification presented by Akum Pharmaceutical with respect to the clinical trial results of the fixed-dose combination...
Indian pharmaceutical market registers 9 percent growth in September: IQVIA Report Susmita Roy3 Nov 2023 5:43 PM ISTNew Delhi: The Indian Pharmaceutical Market (IPM) has witnessed a spike of nine percent in September 2023, according to International Quality and...
Show lung deposition of triple drug combination in Inhalation Suspension: CDSCO Panel tells Glenmark on Pulmonary FDC Drug Dr. Divya Colin2 Nov 2023 5:37 PM ISTNew Delhi: In line with the proposal presented by the drug major Glenmark Pharmaceuticals for the bioequivalence (BE) and Phase III clinical trial...
Drug Safety Alert: Indian Pharmacopoeia Commission flags adverse reactions linked to co-trimoxazole Susmita Roy1 Nov 2023 5:44 PM ISTNew Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of October, has revealed that...
