Regulatory approval Archives

News and Trends 31 Jan 2023

Stemline Therapeutics’ breast cancer treatment approved

The Menarini Group, an Italian pharmaceutical and diagnostics company, says that the U.S. Food and Drug Administration (FDA) has approved ORSERDU for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Stemline Therapeutics, a wholly-owned subsidiary […]

January 31, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 31 Jan 2023

Stargardt disease treatment gets FDA fast track

Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation (FTD) for MCO-010. MCO-010 is an ambient-light activatable multi-characteristic opsin (MCO) optogenetic monotherapy to restore vision in blind patients, for the treatment of Stargardt disease to […]

January 31, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 31 Jan 2023

Abbisko Therapeutics receives breakthrough therapy designation for CSF-1R inhibitor

Abbisko Therapeutics Co., Ltd. has announced that its CSF-1R inhibitor Pimicotinib has been granted the breakthrough therapy designation from the FDA for the treatment of tenosynovial giant cell tumor (TGCT) patients that are not amenable to surgery. The designation approval is based on results from the phase Ib clinical trial of TGCT cohort for Pimicotinib. […]

January 31, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 27 Jan 2023

EMA accepts Marketing Authorization Application for lecanemab to treat early Alzheimer’s disease

BioArctic AB’s partner Eisai says the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab. Lecanemab, known as LEQEMBI in the U.S., is an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed […]

January 27, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 27 Jan 2023

Dupixent gets EU nod for children with severe atopic dermatitis

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent (dupilumab), recommending expanded approval in the European Union (EU) to treat severe atopic dermatitis in children six months to five years old who are candidates for systemic therapy. The European Commission is expected to announce a final […]

January 27, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 26 Jan 2023

Milestone for gene-edited therapy for sickle cell disease

Vertex Pharmaceuticals (Europe) and CRISPR Therapeutics have announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application of exa-cel for the treatment of sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). The submission is supported by two global phase 3 studies investigating exa-cel as a potential one-time therapy for people with […]

January 26, 2023 - 3 minutesmins - By Jim Cornall

Woman looking through a window and seeing biotechnology such as pills and vaccines. It indicates the biotech trends coming in the future

Best in Biotech 12 Jan 2023

The biggest biotech trends that will shape 2023

2023 has begun at full throttle. We have collected seven major biotech trends that industry experts are keeping an eye on over the next 12 months. Just like that, another year has begun. 2023 has already launched with announcements of big pharma acquisitions and the approval of Eisai and Biogen’s Alzheimer’s drug lecanemab by the […]

January 12, 2023 - 9 minutesmins - By Jonathan Smith

News and Trends 11 Jan 2023

AstraZeneca’s Airsupra gets US approval as new rescue treatment for asthma

Avillion LLP says the US Food and Drug Administration (FDA) has approved AstraZeneca’s Airsupra for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. Airsupra, (albuterol/budesonide, formerly known as PT027) is a first-in-class, pressurized metered-dose inhaler (pMDI), fixed-dose combination rescue medication […]

January 11, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 4 Jan 2023

Infex’s novel AMR drug candidate MET-X receives FDA QIDP designation

Infex Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has granted qualified infectious disease product (QIDP) designation to MET-X, the company’s broad spectrum metallo-beta-lactamase (MBL) inhibitor. Infex Therapeutics’ MET-X is a resistance bypass treatment that targets Gram-negative Enterobacterales. These pathogens produce MBL enzymes to deactivate beta-lactam antibiotics and evade antibiotic clearance of […]

January 4, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 3 Jan 2023

Legend Biotech new drug application approved in China

Legend Biotech Corporation has announced that China’s National Medical Products Administration (NMPA) has formally accepted its new drug application (NDA) for ciltacabtagene autoleucel (cilta-cel). This submission is based on data from the confirmatory phase 2 clinical study CARTIFAN-1, conducted in China, which evaluated the efficacy and safety of cilta-cel in adult patients with relapsed or […]

January 3, 2023 - 3 minutesmins - By Jim Cornall

In Depth 20 Dec 2022

Ebvallo approval ushers in off-the-shelf T-cell immunotherapies

Patient-derived CAR-T immunotherapies have dominated the cancer immunotherapy space over the last decade. The EU approval of Atara Biotherapeutics’ Ebvallo marks the first immunotherapy based on T cells sourced from healthy donors. Since the approvals of Kymriah and Yescarta in 2017, CAR-T immunotherapies have changed the way we treat rare forms of blood cancer. In […]

December 20, 2022 - 6 minutesmins - By Jonathan Smith

fungi fungal infections Scopulariopsis brevicaulis

News and Trends 20 Dec 2022

F2G looks for FDA new drug application approval for invasive fungal infections treatment

F2G Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its new drug application (NDA) for olorofim for the treatment of invasive fungal infections in patients who have limited or no treatment options. F2G has requested approval of the NDA under the Limited Population Pathway for Antibacterial and Antifungal […]

December 20, 2022 - 3 minutesmins - By Jim Cornall

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Regulatory approval

Stemline Therapeutics’ breast cancer treatment approved

Stargardt disease treatment gets FDA fast track

Abbisko Therapeutics receives breakthrough therapy designation for CSF-1R inhibitor

EMA accepts Marketing Authorization Application for lecanemab to treat early Alzheimer’s disease

Dupixent gets EU nod for children with severe atopic dermatitis

Milestone for gene-edited therapy for sickle cell disease

The biggest biotech trends that will shape 2023

AstraZeneca’s Airsupra gets US approval as new rescue treatment for asthma

Infex’s novel AMR drug candidate MET-X receives FDA QIDP designation

Legend Biotech new drug application approved in China

Ebvallo approval ushers in off-the-shelf T-cell immunotherapies

F2G looks for FDA new drug application approval for invasive fungal infections treatment

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

Top biotech deals of February 2025

Grab your free report on 3D organoids and explore their future potential

These 7 biotechs are shaping the next generation of endometriosis care

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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

Top biotech deals of February 2025

Grab your free report on 3D organoids and explore their future potential

These 7 biotechs are shaping the next generation of endometriosis care

Connect with decision-makers and researchers worldwide for collaborative opportunities

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Advertise with us

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