TG Therapeutics lymphatic cancer treatment Ukoniq no longer authorised by USFDA Ruchika Sharma2 Jun 2022 3:55 PM ISTThe U.S. health regulator said based on updated clinical trial data it has determined that the risks of treatment with Ukoniq outweigh its benefits.
Regrow Biosciences bags USFDA nod for phase II trial of orphan drug Ossgrow in US Ruchika Sharma1 Jun 2022 4:05 PM ISTOsteonecrosis, mainly seen in the hip joint, is a progressive bone disease that leads to the death of bone tissue due to interrupted blood supply.
Roche gets USFDA nod for spinal muscular atrophy therapy Evrysdi for babies below 2 months Ruchika Sharma31 May 2022 4:02 PM ISTOf the babies with 2 or 3 copies of the SMN2 gene (n=6), 100% were able to sit after one year of treatment with Evrysdi, 67% could stand and 50% of...
Sanofi Dupixent under USFDA priority review for adults with prurigo nodularis Ruchika Sharma31 May 2022 2:41 PM ISTDupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not...
Tadalafil switch from Rx to OTC: USFDA puts a clinical hold on Sanofi's Trial Ruchika Sharma30 May 2022 5:00 PM ISTParis: Sanofi has announced that U.S. Food and Drug Administration (USFDA) has placed clinical hold on its planned Actual Use Trial (AUT) to support...
Novartis Kymriah gets USFDA nod for relapsed or refractory follicular lymphoma Ruchika Sharma30 May 2022 12:19 PM IST"Kymriah is now FDA approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings," claims the...
Strides Pharma bags USFDA nod for pain relief drug Ruchika Sharma30 May 2022 11:51 AM ISTThe medicine will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
Setback: Eton Pharma anti-seizure drug Lamotrigine rejected by USFDA Ruchika Sharma29 May 2022 12:00 PM ISTThe drug is a liquid form of a widely available anticonvulsant or antiepileptic oral tablet, which also goes by the name lamotrigine.
Pfizer gets USFDA Fast Track Designation for Ervogastat plus Clesacostat to treat NASH Ruchika Sharma28 May 2022 11:57 AM ISTDiacylglycerol O-acyltransferase 2 (DGAT2) and acetyl-CoA carboxylase (ACC) are two key enzymes that regulate lipid metabolism. Inhibitors of ACC and...
Zydus Lifesciences gets EIR from USFDA for Jarod facility Ruchika Sharma28 May 2022 11:33 AM ISTThe inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs.
Zydus Lifesciences Chemotherapy drug Pemetrexed gets USFDA okay Ruchika Sharma26 May 2022 1:29 PM ISTThe drug will be manufactured at Zydus Hospira.
Aurobindo Pharma arm bags USFDA nod for Pemetrexed for Injection Ruchika Sharma26 May 2022 1:14 PM ISTPemetrexed for injection is indicated for the treatment of Antineoplastics (medications used to treat cancer)
