approval | PharmaShots

Janssen’s Darzalex (daratumumab, SC) Receives Health Canada Approval for the Treatment of Patients with Multiple Myeloma

August 4, 2020August 4, 2020Tuba Khan

Shots: The Health Canada has approved Darzalex SC (daratumumab) in four regimens across five indications in patients with MM, notably newly diagnosed, transplant-ineligible [Read More...]

MorphoSys’ Monjuvi (tafasitamab-cxix) + Lenalidomide Receives the US FDA’s Approval as 2L Treatment for Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

August 3, 2020August 3, 2020Tuba Khan

Shots: The approval is based on P-II L-MIND study assessing Monjuvi in combination with lenalidomide as a treatment for adult patients with relapsed [Read More...]

Roche Receives the US FDA’s Approval for VENTANA HER2 Dual ISH Test as CDx to Identify Breast Cancer

July 31, 2020July 31, 2020Tuba Khan

Shots: The US FDA has approved the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay to detect HER2 biomarker in BC and [Read More...]

Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

July 31, 2020July 31, 2020Tuba Khan

Shots: The approval is based on P-III IMspire150 study assessing Tecentriq (atezolizumab) + Cotellic (cobimetinib) + Zelboraf (vemurafenib) vs PBO + Cotellic + [Read More...]

Henlius and Accord Receive CHMP’s Positive Opinion for its HLX02 (biosimilar, trastuzumab)

Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

July 30, 2020July 30, 2020Shiwani Sharma

Shots: The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of [Read More...]

UCB’s Cimzia (certolizumab pegol) Receives Health Canada Approval for Non-Radiographic Axial Spondyloarthritis

UCB Canada’s Brivlera (brivaracetam) Receives Health Canada Approval to Treat Partial-Onset Seizures in Pediatric Epilepsy Patients

July 30, 2020July 30, 2020Shiwani Sharma

Shots: The approval is based on the principle of extrapolation of its efficacy data in adults also supported by pharmacokinetic and safety data [Read More...]

Zebra Medical Receives the US FDA’s Approval for its HealthMammo Mammography Tool

July 28, 2020July 28, 2020Tuba Khan

Shots: The US FDA has granted 510 (k) clearance to HealthMammo for boosting early detection of breast cancer in mammograms The tool utilizes [Read More...]

Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL

July 27, 2020July 27, 2020Tuba Khan

Shots: The accelerated approval follows FDA’s PR and BT designation and is based on ZUMA-2 study assessing Tecartus (formerly KTE-X19) in 74 patients [Read More...]

AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Approval for Reducing the Risk of Hospitalization for Heart Failure in Patients with Type-2 Diabetes

AstraZeneca’s Breztri Aerosphere Receives the US FDA’s Approval for the Maintenance Treatment of COPD

July 24, 2020July 24, 2020Tuba Khan

Shots: The approval is based on P-III ETHOS study assessing of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) vs dual therapies [Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and [Read More...]

Abbott’s IOS-Compatible App Receives the US FDA’s Approval for Patients with Neurological Disorder

July 24, 2020July 24, 2020Tuba Khan

Shots: The US FDA approves Abbott’s patient controller app for use on Apple’s smartphone devices, allowing patients with neurological conditions such as chronic [Read More...]