Regulatory approval Archives

News and Trends 22 Jun 2023

FDA approves type 2 diabetes drug for children 10 and older

The U.S. Food and Drug Administration (FDA) has approved Jardiance (empagliflozin) 10 mg and 25 mg tablets to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company have announced. “As the burden of type 2 diabetes increases among young […]

June 22, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 20 Jun 2023

Clearance for anti-tumor bispecific antibody trial

TG ImmunoPharma Co., Ltd. (TGI), which focuses on the development of novel immuno-oncology therapies, says the FDA has granted clearance for the clinical trial of TGI-6, its bispecific antibody. TGI-6 targets unique tumor-associated antigens (TAA) and CD3 molecules simultaneously, enabling potent anti-tumor responses. TGI said the antibody demonstrates exceptional anti-tumor activity, favorable safety profiles, and […]

June 20, 2023 - 2 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 13 Jun 2023

CellCentric receives FDA Fast Track designation for relapsed refractory multiple myeloma drug

CellCentric has announced that the U.S. Food and Drug Administration (FDA) has granted its novel cancer drug, inobrodib, Fast Track designation for the treatment of patients with relapsed or refractory multiple myeloma. The FDA’s Fast Track designation is designed to aid the development of new treatments, expediting the review of drugs to treat serious conditions […]

June 13, 2023 - 3 minutesmins - By Jim Cornall

Opinion 13 Jun 2023

How will European Commission proposals on data exclusivity and the bolar exemption affect pharma companies?

By Andrew Sharples, co-head of EIP’s UK litigation team In April, the European Commission published proposed legislation (specifically a new Regulation and a new Directive) aimed at reforming EU legislation in relation to pharmaceuticals. These proposals, if adopted, will affect pharmaceutical regulation in several ways. In relation to IP specifically, they will affect the periods […]

June 13, 2023 - 5 minutesmins - By External Contributor

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

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 pyruvate kinase deficiency (PKD). PKD is a rare blood disorder characterized by severe anemia and excessive red blood cell breakdown. RMAT designation was granted based […]

May 26, 2023 - 4 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 older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. The approval of Vyjuvek was granted to […]

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 by the U.S. FDA. Also, due to the serious manifestations of this rare skeletal disorder in children, SIS-101-ADO has been granted rare pediatric disease designation […]

May 16, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 15 May 2023

New menopause drug gets FDA approval

The U.S. Food and Drug Administration has approved Astellas Pharma’s Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Astellas Pharma US, Inc.’s Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from […]

May 15, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 9 May 2023

Fabry disease treatment gets EU marketing authorization

Chiesi Global Rare Diseases and Protalix BioTherapeutics, Inc. have announced that the European Commission (EC) has granted marketing authorization to PRX-102 (pegunigalsidase alfa) in the European Union (EU) for the treatment of adult patients with Fabry disease. “People living with Fabry disease often perceive their disease as burdensome and still experience unmet medical needs,” said […]

May 9, 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 syncytial virus (RSV) in individuals 60 years of age and older. It is the first RSV vaccine for older adults to be approved anywhere in […]

May 4, 2023 - 5 minutesmins - By Jim Cornall

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Regulatory approval

FDA approves type 2 diabetes drug for children 10 and older

Clearance for anti-tumor bispecific antibody trial

Nordic Bioscience cancer biomarker gets FDA go ahead

CellCentric receives FDA Fast Track designation for relapsed refractory multiple myeloma drug

How will European Commission proposals on data exclusivity and the bolar exemption affect pharma companies?

von Willebrand disease treatment gets FDA orphan drug designation

Rocket Pharmaceuticals receives FDA designation for pyruvate kinase deficiency gene therapy

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

SiSaf siRNA therapy gets FDA designations to treat autosomal dominant osteopetrosis

New menopause drug gets FDA approval

Fabry disease treatment gets EU marketing authorization

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

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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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