AstraZeneca and Daiichi Sankyo announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted priority review.
DBV Technologies, a clinical-stage biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for its investigational Viaskin Peanut immunotherapy for the treatment of peanut-allergic children ages 4 to 11 years.
GlaxoSmithKline (GSK) and Innoviva have filed an application for their respiratory drug Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI) in the US seeking its use for the treatment of asthma in adults.
EMD Serono, the biopharmaceutical business of Merck, and Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BAVENCIO (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
AstraZeneca’s Farxiga (dapagliflozin) has been granted fast track designation from the US Food and Drug Administration (FDA) for its use in reducing the risk of heart failure.
A committee of the US Food and Drug Administration (FDA) has voted in favour of the use of Aimmune Therapeutics’ AR101 for the treatment of peanut allergy in children and teens.
Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for teprotumumab, an investigational medicine for the treatment of active thyroid eye disease (TED), and granted it Priority Review designation.
Emalex Biosciences, Inc. (Emalex), a biopharmaceutical company developing innovative therapies for patients with neurological and psychiatric conditions, announced today that it has received Fast Track designation for its investigational product, ecopipam, from the U.S. Food and Drug Administration (FDA) for the treatment of patients with Tourette Syndrome (TS).
AstraZeneca’s Fasenra (benralizumab) has been granted orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of eosinophilic oesophagitis (EoE).
Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company, is pleased to announce the acceptance of the Investigation New Drug (IND) application for SLS-005 (trehalose) by the Food and Drug Administration (FDA).
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