Tags : US

Janssen Reports sBLA Submission to the US FDA for Darzalex

Shots: The sBLA submission is based on P-III ANDROMEDA study assessing Darzalex Faspro (SC) + bortezomib, cyclophosphamide, and dexamethasone (D-VCd) vs VCd as monothx. in 388 patients with newly diagnosed (AL) amyloidosis The study resulted in meeting its 1EPs overall hematologic complete response rate. The sBLA is being reviewed under the FDA’s RTOR program and […]Read More

ViewPoints Interview: Genentech’s Ted Omachi Shares Insights on Xolair (omalizumab)

The US FDA has accepted the sBLA for a new self-administration option for Xolair (omalizumab) across all approved US indications. In an interview with PharmaShots, Ted Omachi the Global Development Leader for Xolair and Senior Medical Director of Product Development Immunology shares details and highlights of Xolair (omalizumab) PFS for self-administration. Shots: A decision on […]Read More

Roche’s cobas BKV Test Receives the US FDA’s 510 (k)

Shots: The test provides standardized results to assess the risk of complications caused by the BK virus in transplant patients and identify effective treatment options It has received FDA’s BDD for improved treatment/diagnosis of life-threatening diseases for transplant patients. The approval allows Roche to offer HCPs a transplant testing portfolio that includes Cytomegalovirus, Epstein-Barr virus, […]Read More

Project ALS’ Prosetin Receives the US FDA’s Orphan Drug Designation

Shots: The US FDA has granted ODD to Prosetin for the treatment of ALS. ODD provides incentives for the development of drugs, biologics, and devices for diseases affecting 200,000 or fewer Americans By obtaining ODD, Prosetin is now eligible for benefits including up to 7yrs. of marketing exclusivity if it receives regulatory approval, exemption from […]Read More

Kite Reports sBLA Submission to the US FDA for Yescarta

Shots: The sBLA submission is based on an ongoing P-II ZUMA-5 study assessing single infusion of Yescarta in ~160 patients (≥18 yrs.) with r/r indolent NHL of either FL or marginal zone lymphoma subtypes, prior treated with 2L therapies, including an anti-CD20 mAb combined with an alkylating agent The 1EPs of the study is ORR […]Read More

Roche Receives the US FDA’s EUA for cobas SARS-CoV-2 and

Shots: The US FDA has granted EUA for cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems to qualitatively detects and differentiate SARS-CoV-2, Influenza A and B in patients suspected of having respiratory viral infection consistent with COVID-19 The test is a multiplex RT-PCR assay intended to detect the virus in […]Read More

Baxter’s Theranova Dialyzers Receives the US FDA’s De Novo Authorization

Shots: The US FDA has granted De Novo authorization to Theranova that delivers expanded hemodialysis (HDx) therapy by filtering the wider range of molecules from the blood, targeting the effective removal of conventional (500-25 kDa) and large middle molecules (25-45 kDa) The Theranova cartridge is designed to be used with existing dialysis machines and offers […]Read More