Regulatory approval Archives

News and Trends 7 Jul 2023

FDA approves Alzheimer’s treatment

Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI (lecanemab-irmb) 100 mg/mL injection for intravenous use. The decision makes LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression […]

July 7, 2023 - 5 minutesmins - By Jim Cornall

News and Trends 5 Jul 2023

Narcolepsy drug gets Chinese approval

RareStone Group, a rare disease-focused company aiming to establish the first rare disease ecosystem in China, has announced that the Chinese National Medical Products Administration (NMPA) has approved pitolisant (Wakix) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. In China, pitolisant is the first approved innovative drug for […]

July 5, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 4 Jul 2023

Innovent and IASO Bio obtain approval for CAR-T multiple myeloma treatment

Innovent Biologics, Inc. and IASO Biotechnology have announced that China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for FUCASO (Equecabtagene Autoleucel). FUCASO is the first fully-human BCMA-directed chimeric antigen receptor (CAR) T-cell therapy for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior […]

July 4, 2023 - 4 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

News and Trends 27 Jun 2023

UCB myasthenia gravis drug given FDA approval

UCB has announced RYSTIGGO (rozanolixizumab-noli) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. Rozanolixizumab-noli injection for subcutaneous infusion is a humanized IgG4 monoclonal antibody that binds to the neonatal […]

June 27, 2023 - 5 minutesmins - By Jim Cornall

News and Trends 26 Jun 2023

AbbVie takes step forward in Europe with migraine drug

AbbVie says the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CMHP) has adopted a positive opinion recommending the approval of atogepant for the prophylaxis of migraine in adults who have four or more migraine days per month. If approved, AbbVie will be the only company to offer a once daily oral […]

June 26, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 23 Jun 2023

Sarepta gets approval for first gene therapy for Duchenne muscular dystrophy

Sarepta Therapeutics, Inc. has announced U.S. Food and Drug Administration (FDA) accelerated approval of ELEVIDYS (delandistrogene moxeparvovec-rokl), an Adeno-associated virus (AAV)-based gene therapy for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene. This indication is approved under accelerated approval […]

June 23, 2023 - 3 minutesmins - By Jim Cornall

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

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Regulatory approval

FDA approves Alzheimer’s treatment

Narcolepsy drug gets Chinese approval

Innovent and IASO Bio obtain approval for CAR-T multiple myeloma treatment

FDA approves BioMarin gene therapy for hemophilia A

FDA gives Orphan Drug Designation to CellCentric multiple myeloma drug

UCB myasthenia gravis drug given FDA approval

AbbVie takes step forward in Europe with migraine drug

Sarepta gets approval for first gene therapy for Duchenne muscular dystrophy

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

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Catalonia: A biotech hub going from strength to strength, with Barcelona at its core

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