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Drug news

Positive CHMP opinion for Gohibic (vilobelimab) for the treatment of SARS-CoV-2-induced acute respiratory distress syndrome

InflaRx N.V., a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization of GOHIBIC (vilobelimab), under exceptional circumstances for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO))

1 mins

Drug news

FDA approval for Danziten (nilotinib) to treat Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML)

Azurity Pharmaceuticals announced that the FDA has approved Danziten, the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and adult patients with chronic phase (CP) and acute phase (AP) resistant or intolerant to prior therapy that included imatinib

1 min

Drug news

CHMP recommends Rybrevant (amivantamab) plus Lazcluze (lazertinib) for the first-line treatment of EGFR-mutated advanced non-small cell lung cancer

Janssen-Cilag International NV, a Johnson & Johnson company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the Marketing Authorisation (MA)for Lazcluze (lazertinib), in combination with Rybrevant (amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations

2 min

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