Beximco buys eight ANDAs in US from Novartis’ Sandoz
Beximco Pharmaceuticals Limited will buy from Novartis’ Sandoz a portfolio of eight Abbreviated New Drug Applications (ANDAs) in the US
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FDA
FDA approves Teva’s Sabril generic version; says making generic drugs competitive is key part to reduce drug cost
Announcing the approval of Teva’s Sabril generic tablets, FDA Commissioner, Scott Gottlieb said that prioritizing the approval of generic drugs to compete with medicines that face little or no competition is the Agency’s key part of efforts to support access and reduce drug costs to patients.
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Novartis locks Breakthrough Therapy for crizanlizumab in US, for prevention of sickle pain crises
Novartis has secured its crizanlizumab (SEG101) Breakthrough Therapy designation US Food and Drug Administration (FDA), for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD).
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MatriSys asks for meeting with FDA over anti-atopic dermatitis topical drug candidate
MatriSys Bioscience is waiting to meet with the US FDA to complete preparations for its company-sponsored Phase 2 trial of its anti-atopic dermatitis topical drug candidate, MSB-01, it said Wednesday.
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PledPharma seeks to cut costs for Aladote, expects orphan drug designation
PledPharma has filed an application for an Orphan Drug Designation (ODD) to the US FDA for the its drug candidate which should reduce liver injury by paracetamol overdose, Aladote.
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FDA grants Fast Track designation in the US for Nordic Nanovector’s Follicular Lymphoma drug
The US Food & Drug Administration (FDA) has granted Fast Track designation to Nordic Nanovector’s Betalutin (177Lu-lilotomab satetraxetan) for the treatment of
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FDA accepts larotrectinib Bayer’s New Drug Application and grants priority review
The U.S. Food and Drug Administration (FDA) has accepted Bayer’s partner’s Loxo Oncology’s New Drug Application (NDA), and granted Priority
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FDA OK’s AkaRx’s liver drug
The U.S. Food and Drug Administration has approved AkaRx’s Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with
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Lilly’s psoriasis treatment first FDA approved to include data in psoriasis involving the genital area
Eli Lilly said Tuesday that the U.S. Food and Drug Administration (FDA) has approved a label update for Taltz injection 80 mg/mL to
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Ultragenyx Pharmaceutical’s Crysvita first FDA-approved medication for the treatment of XLH
The U.S. Food and Drug Administration has approved Ultragenyx Pharmaceutical’s Crysvita (burosumab), the first drug approved to treat adults and children ages
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