FDA Archives

In Depth 26 Oct 2023

Behind closed doors: The unseen controversies and scandals in Alzheimer’s drug trials

Alzheimer’s disease is the most common form of dementia – which currently affects more than 55 million people globally – making up 60% to 70% of cases. It is a complex disease, encompassing multiple interrelated and progressive destructive processes in the brain, resulting in neuron damage that extends to parts of the brain that enable […]

October 26, 2023 - 11 minutesmins - By Willow Shah-Neville

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 after Australia became the first country to allow doctors to prescribe the drug to those struggling with mental health disorders like PTSD and depression. Recognizing […]

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 skipping therapy. The breakthrough designation is based on results from a first-in-human, investigator-initiated clinical trial conducted in Japan. In June 2023, NS-089/NCNP-02 was granted Rare […]

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 follows the company closing a secondary public offering and entering into subscription agreements for all 2,776,000 H-shares offered by way of private placement, within the […]

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 infants born during or entering their first RSV season. The approval also covers children up to 24 months of age who remain vulnerable to severe […]

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 (congenital factor VIII (FVIII) deficiency with FVIII activity < 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test. The […]

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 an oral capsule, inobrodib can be used at home without requiring intensive monitoring. It is a first-in-class drug, with a new mechanism of action. It […]

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 II trial and aims to demonstrate proof of concept by assessing the efficacy of the NgG vaccine in healthy adults, 18 to 50 years of […]

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 of patients with relapsed or refractory multiple myeloma (rrMM). The clinical hold was received on June 16, following a recent patient death. The company said […]

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 further study of the PRO-C3 biomarker assay as a prognostic biomarker in tumor fibrosis studies. Nordic Bioscience has a successful track record of developing and […]

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) patients with cerebral adrenoleukodystrophy (cALD). X-ALD is an orphan neurodegenerative disease. The global incidence of X-ALD is approximately six to eight per 100,000 live births. […]

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 disease (VWD). Vega Therapeutics is a clinical stage biotechnology company developing novel therapies for rare blood disorders. VGA039 is a first-in-class antibody therapy with a […]

June 2, 2023 - 2 minutesmins - By Jim Cornall

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FDA

Behind closed doors: The unseen controversies and scandals in Alzheimer’s drug trials

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

FDA grants breakthrough therapy designation to Duchenne muscular dystrophy treatment

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

FDA approves Beyfortus ahead of 2023-24 RSV season

FDA approves BioMarin gene therapy for hemophilia A

FDA gives Orphan Drug Designation to CellCentric multiple myeloma drug

GSK gonorrhea vaccine fast tracked

FDA puts hold on Arcellx myeloma program following patient death

Nordic Bioscience cancer biomarker gets FDA go ahead

Minoryx can start phase 3 trial for cerebral adrenoleukodystrophy patients

von Willebrand disease treatment gets FDA orphan drug designation

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10 oncology deals in 2025 spotlight where industry leaders are betting big

10 biotech companies leading the way in Denmark

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

10 oncology deals in 2025 spotlight where industry leaders are betting big

10 biotech companies leading the way in Denmark

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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