FDA Archives

News and Trends 22 Sep 2023

U.S. approval for psychedelic drug MDMA nears after success in clinic

The psychedelic drug MDMA edges closer towards FDA approval for the treatment of post-traumatic stress disorder (PTSD) in the U.S., after promising results of a trial were published. This comes…

September 22, 2023 - 7 minutesmins - By Roohi Mariam Peter

News and Trends 28 Jul 2023

FDA grants breakthrough therapy designation to Duchenne muscular dystrophy treatment

The U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy Designation to NS Pharma Inc.’s NS-089/NCNP-02, an investigational candidate for patients with Duchenne muscular dystrophy amenable to exon 44…

July 28, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 25 Jul 2023

Molecure raises $12M and gets FDA clearance for pulmonary sarcoidosis trial

Molecure S.A. has received clearance from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application to conduct phase II clinical testing of OATD-01. The announcement…

July 25, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 18 Jul 2023

FDA approves Beyfortus ahead of 2023-24 RSV season

The U.S. Food and Drug Administration (FDA) has approved Sanofi and AstraZeneca’s Beyfortus (nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and…

July 18, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 30 Jun 2023

FDA approves BioMarin gene therapy for hemophilia A

BioMarin Pharmaceutical Inc. has announced that the United States Food and Drug Administration (FDA) has approved ROCTAVIAN (valoctocogene roxaparvovec-rvox) gene therapy for the treatment of adults with severe hemophilia A…

June 30, 2023 - 5 minutesmins - By Jim Cornall

News and Trends 29 Jun 2023

FDA gives Orphan Drug Designation to CellCentric multiple myeloma drug

CellCentric, a UK-based biotechnology company, has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for inobrodib in the treatment of multiple myeloma. Delivered as…

June 29, 2023 - 3 minutesmins - By Jim Cornall

Neisseria gonorrhoeae gonorrhoea gonorrhea

News and Trends 27 Jun 2023

GSK gonorrhea vaccine fast tracked

The US Food and Drug Administration (FDA) has granted a Fast Track designation for GSK plc's Neisseria gonorrhoeae investigational vaccine (NgG). The vaccine candidate is currently in an ongoing phase…

June 27, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 20 Jun 2023

FDA puts hold on Arcellx myeloma program following patient death

Arcellx, Inc. has received notification from the U.S. Food and Drug Administration (FDA) that a clinical hold has been placed on its CART-ddBCMA investigational new drug (IND) for the treatment…

June 20, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 15 Jun 2023

Nordic Bioscience cancer biomarker gets FDA go ahead

Danish biomarker company Nordic Bioscience says its PRO-C3 biomarker assay has received a Letter of Support (LoS) from the U.S. Food and Drug Administration (FDA). The letter acknowledges and supports…

June 15, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 8 Jun 2023

Minoryx can start phase 3 trial for cerebral adrenoleukodystrophy patients

Spanish-headquartered Minoryx Therapeutics says the U.S. Food and Drug Administration (FDA) has approved its phase 3 clinical trial (CALYX) of lead candidate leriglitazone, to treat adult male X-linked adrenoleukodystrophy (X-ALD)…

June 8, 2023 - 4 minutesmins - By Jim Cornall

blood bleeding disorders von Willebrand disease

News and Trends 2 Jun 2023

von Willebrand disease treatment gets FDA orphan drug designation

The U.S. Food and Drug Administration (FDA) has granted Vega Therapeutics, Inc. orphan drug designation for its antibody therapy, VGA039, for the treatment of the rare bleeding disorder, von Willebrand…

June 2, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 26 May 2023

Rocket Pharmaceuticals receives FDA designation for pyruvate kinase deficiency gene therapy

Rocket Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-L301, the company’s investigational lentiviral-based gene therapy for…

May 26, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 23 May 2023

FDA approval for Rznomics’ glioblastoma treatment trial

Rznomics Inc., a South Korea based biopharmaceutical company specializing in the development of RNA-based gene therapeutics, has received phase 1/2a IND approval from the U.S. FDA for its glioblastoma multiforme…

May 23, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 22 May 2023

FDA approves first topical gene therapy for dystrophic epidermolysis bullosa wound treatment

The U.S. Food and Drug Administration has approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and…

May 22, 2023 - 3 minutesmins - By Jim Cornall

Osteopetrosis ADO2 radiopaedia case ID 8037

News and Trends 16 May 2023

SiSaf siRNA therapy gets FDA designations to treat autosomal dominant osteopetrosis

SiSaf Ltd, an RNA delivery and therapeutics company, has announced that SIS-101-ADO, its siRNA therapeutic for patients with autosomal dominant osteopetrosis Type 2 (ADO2), has been granted orphan drug designation…

May 16, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 4 May 2023

World’s first RSV vaccine for older adults gets FDA approval

GSK plc says the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory…

May 4, 2023 - 5 minutesmins - By Jim Cornall

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…

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…

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…

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…

April 27, 2023 - 5 minutesmins - By Jim Cornall

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