MedicineNews.net - Medical Updates

Pfizer has requested Emergency Use Authorization to FDA for COVID-19 vaccine in children 5 to less than 12 years of age

Pfizer and BioNTech have announced they have submitted data to the U.S. Food and Drug Administration ( FDA ) from the phase 2/3 trial of their COVID-19 vaccine in children 5 to less than 12 years of a ... read article

New frontiers in multiple myeloma: Ciltacabtagene autoleucel, a BCMA-directed CAR-T therapy

Cilta-cel ( Ciltacabtagene autoleucel ) is an investigational BCMA-directed CAR-T therapy in development for the treatment of adults with relapsed and/or refractory multiple myeloma. CAR‑T therapy is ... read article

Norwegian Medicines Agency: blood clots and bleeding in younger people after vaccination with AstraZeneca vaccine

The Norwegian Medicines Agency has received several adverse event reports about younger vaccinated people with bleeding under the skin ( tiny dots and / or larger blue patches ) after coronavirus vacc ... read article

Pfizer-BioNTech COVID-19 vaccine: CDC Report on December 23, 2020

As of December 23, 2020, a reported 1,893,360 first doses of Pfizer-BioNTech COVID-19 vaccine had been administered in the United States, and reports of 4,393 ( 0.2% ) adverse events after receipt of ... read article

FDA: four-week dosing approved in all Imfinzi indications, reducing medical visits and improving patient convenience

Imfinzi ( Durvalumab ) has been approved in the US for an additional dosing option, a 1,500 mg fixed dose every four weeks, in the approved indications of unresectable stage III non-small cell lung ca ... read article

Xalkori for the treatment of pediatric ALK-positive anaplastic large cell lymphoma: FDA has accepted supplemental new drug application

The FDA ( U.S. Food and Drug Administration ) has accepted and granted priority review to the supplemental New Drug Application( sNDA ) for Crizotinib ( Xalkori ) for the treatment of pediatric patien ... read article

DMC Committee has recommended continuation without changes of phase 3 clinical trial of Omecamtiv Mecarbil in patients with heart failure

The second and final planned interim analysis of the GALACTIC-HF trial, which has included consideration of pre-specified criteria for futility and superiority, was completed. The DMC ( Data Monitori ... read article

FDA on use of non-steroidal anti-inflammatory drugs for COVID-19

FDA ( Food and Drug Administration ) is aware of news reports stating the use of non-steroidal anti-inflammatory drugs ( NSAIDs ), such as Ibuprofen, could worsen coronavirus disease ( COVID-19 ). T ... read article

Muscle-invasive urothelial cancer: Atezolizumab as adjuvant monotherapy treatment did not meet its primary endpoint in IMvigor010

The phase III IMvigor010 study evaluating Atezolizumab ( Tecentriq ) as an adjuvant ( after surgery ) monotherapy treatment did not meet its primary endpoint of disease-free survival ( DFS ) compared ... read article

Pirfenidone reduces scar tissue in patients with heart failure and preserved ejection fraction

Patients with heart failure with preserved ejection fraction who took the antifibrotic drug Pirfenidone ( Esbriet ) saw a significant reduction in a marker of heart muscle scarring compared with patie ... read article

FDA has approved Fragmin for venous thromboembolism in pediatric patients

The Food and Drug Administration ( FDA ) has approved Fragmin ( Dalteparin sodium ) to reduce the recurrence of symptomatic venous thromboembolism ( VTE ) in pediatric patients 1 month of age and olde ... read article

Safety of sodium-glucose co-transporter 2 inhibitors

Sodium-glucose co-transporter 2 ( SGLT2 ) inhibitors have a well-defined safety profile based on data obtained from numerous clinical trials, including cardiovascular outcomes trials ( CVOTs ) and pos ... read article

Consensus on Testosterone treatment for postmenopausal women with hypoactive sexual desire dysfunction

The Endocrine Society and 10 other internationally esteemed medical societies have issued the first Global Position Statement on the use of Testosterone in the treatment of women. It follows years ... read article

Treatment of hypertension induced albuminuria

Albuminuria is a renal disease that is found to be independently associated with cardiovascular and renal problems without any links to diabetes. In latest ESC/ESH guidelines, microalbuminuria has ... read article

Fluoroquinolones associated with cardiovascular risk

Several fluoroquinolone antibiotics have been associated with cardiac adverse effects, leading to the withdrawal of some of these agents from the market. Cardiac side effects such as QT prolongation ... read article