Jazz Pharmaceuticals and PharmaMar have secured accelerated approval from the US Food and Drug Administration (FDA) for Zepzelca (lurbinectedin) for the treatment of metastatic small cell lung cancer (SCLC).
NeoImmuneTech, a clinical-stage T cell-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NeoImmuneTech’s NT-I7 (efineptakin alfa), the only clinical-stage long-acting human IL-7, for the treatment of Progressive Multifocal Leukoencephalopathy (PML).
ViiV Healthcare has been granted approval by the US Food and Drug Administration (FDA) for Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for suspension for the treatment of human immunodeficiency virus type 1 (HIV-1) in infants and children.
Vertex Pharmaceuticals has secured approval from the European Commission (EC) for its Kalydeco (ivacaftor) to treat children and adolescents with cystic fibrosis (CF).
Merck has secured approval from the US Food and Drug Administration (FDA) for its Recarbrio (imipenem, cilastatin, and relebactam) to treat adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
Pierre Fabre has secured approval from the European Commission (EC) for Braftovi (encorafenib) plus cetuximab (Erbitux) to treat adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) who have received prior systemic therapy.
AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Brilinta (ticagrelor) to minimise the risk of a first heart attack or stroke in high-risk patients with a heart disease known as coronary artery disease (CAD).
Genentech has secured approval from the US Food and Drug Administration (FDA) for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC).
Bristol Myers Squibb announced that Opdivo (nivolumab) 360 mg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) given with two cycles of platinum-doublet chemotherapy was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
The US Food and Drug Administration (FDA) approved Dupixent (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is the only biologic medicine approved for this patient population.
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