FDA Archives

News and Trends 2 May 2023

Cabaletta Bio’s lupus drug cleared for trial

Cabaletta Bio, Inc., a U.S. clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation to CABA-201. Cabaletta Bio’s CABA-201 is a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, designed […]

May 2, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 2 May 2023

FDA fast track for Memo’s kidney transplant infection treatment

Memo Therapeutics AG, a biotech company developing therapeutic antibodies, says the U.S. Food and Drug Administration (FDA) has granted fast track designation to AntiBKV, Memo Therapeutics’ lead antibody therapeutic that targets BK polyomavirus (BKV) infection commonly seen in renal transplant patients. AntiBKV has successfully completed a phase I clinical study and following FDA clearance has […]

May 2, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 2 May 2023

Schizophrenia injection gets FDA approval

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and MedinCell have announced the U.S. Food and Drug Administration (FDA) has approved UZEDY (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq, a copolymer technology proprietary to MedinCell that controls […]

May 2, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 27 Apr 2023

Biogen ALS drug gets FDA ok

The U.S. Food and Drug Administration (FDA) has approved Biogen’s QALSODY (tofersen) 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain (NfL) observed in patients […]

April 27, 2023 - 5 minutesmins - By Jim Cornall

News and Trends 20 Apr 2023

FDA approves Genentech’s lymphoma drug

Genentech, a member of the Roche Group, has announced the U.S. Food and Drug Administration (FDA) has approved Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP). The approval covers the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell […]

April 20, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 11 Apr 2023

Sumitomo Pharma Oncology receives orphan drug designation for Ewing sarcoma treatment

Sumitomo Pharma Oncology, Inc., a clinical-stage company focused on novel cancer therapeutics, said the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for TP-1287, an investigational oral CDK9 inhibitor, for the treatment of Ewing sarcoma. “We are delighted to have received this designation for TP-1287 which underscores the need for additional treatment […]

April 11, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 5 Apr 2023

InflaRx receives emergency use authorization for critically ill COVID-19 patients treatment

InflaRx N.V., a German company developing anti-inflammatory therapeutics by targeting the complement system, has announced that Gohibic (vilobelimab) has been granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults. Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody that acts on […]

April 5, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 29 Mar 2023

Pharming immunodeficiency drug given FDA approval

Pharming Group N.V. has announced that the US Food and Drug Administration (FDA) has approved Joenja (leniolisib) for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older. Pharming’s Joenja, an oral, selective PI3Kδ inhibitor, is the first and only treatment approved in the […]

March 29, 2023 - 4 minutesmins - By Jim Cornall

Best in Biotech 9 Mar 2023

5 advancements in kidney disease research over the past year

Prevalent in millions of people across the globe, kidney diseases manifest through various symptoms like blood and excess protein in urine, fluid retention causing swollen ankles, poor appetite and even the inability of the body to filter waste, resulting in acute kidney failure. To boost the research and development of treatments for kidney diseases, Kidney […]

March 9, 2023 - 7 minutesmins - By Roohi Mariam Peter

Interview 3 Mar 2023

Interview: how has the first gene therapy for hemophilia B transformed research?

Hemophilia B, a rare disease that affects more than 230,000 people worldwide is caused by the lack of or defective clotting protein factor IX often due to a spontaneous mutation in the F9 gene, leading to excessive bleeding. Until recently, routine prophylactic infusions of factor IX replacement therapy to maintain enough clotting factor to prevent […]

March 3, 2023 - 8 minutesmins - By Roohi Mariam Peter

News and Trends 3 Mar 2023

Orphan drug designation for Laevoroc metabolic immune checkpoint inhibitor

Laevoroc Immunology, a privately-owned, Swiss oncology development company, has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for immune checkpoint inhibitor LR 09. LR 09 is a novel metabolic immune checkpoint inhibitor, for the treatment of patients with hematological malignancies who are diagnosed with a relapse after allogeneic stem […]

March 3, 2023 - 3 minutesmins - By Jim Cornall

In Depth 3 Mar 2023

Let’s Take a Closer Look at 7 Autoimmune Diseases Biotechs are Fighting to Treat

While we mostly think of disease as being caused by bacteria or viruses, an illness can often occur when the body’s own defenses turn against itself. Here we’ll take a look at seven rare autoimmune diseases you may not have heard of and what biotechs are doing to treat them. The body’s immune system can […]

March 3, 2023 - 8 minutesmins - By Alexander Burik

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The twelve hottest biotech companies in the Boston area

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FDA

Cabaletta Bio’s lupus drug cleared for trial

FDA fast track for Memo’s kidney transplant infection treatment

Schizophrenia injection gets FDA approval

Biogen ALS drug gets FDA ok

FDA approves Genentech’s lymphoma drug

Sumitomo Pharma Oncology receives orphan drug designation for Ewing sarcoma treatment

InflaRx receives emergency use authorization for critically ill COVID-19 patients treatment

Pharming immunodeficiency drug given FDA approval

5 advancements in kidney disease research over the past year

Interview: how has the first gene therapy for hemophilia B transformed research?

Orphan drug designation for Laevoroc metabolic immune checkpoint inhibitor

Let’s Take a Closer Look at 7 Autoimmune Diseases Biotechs are Fighting to Treat

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