Sunovion Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Kynmobi (apomorphine hydrochloride) sublingual film (APL-130277) to treat Parkinson’s disease (PD) off episodes.
AstraZeneca and Merck announced that LYNPARZA (olaparib) has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
Tolero Pharmaceuticals, a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its investigational small-molecule pyruvate kinase M2 isoform (PKM2) activator, TP-1454.
Novartis company AveXis has secured conditional approval from the European Commission (EC) for its Zolgensma (onasemnogene abeparvovec) to treat spinal muscular atrophy (SMA).
Genentech, a member of the Roche Group, announced that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
Can-Fite BioPharma, a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced it has filed a pre-Investigational New Drug (IND) meeting request with the U.S. Food and Drug Administration (FDA) for its drug candidate Piclidenoson in the treatment of COVID-19 patients with moderate-to-severe symptoms.
Deciphera Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Qinlock (ripretinib) to treat fourth-line gastrointestinal stromal tumour (GIST).
Neuraptive Therapeutics, a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products for treatment of peripheral nerve injuries (PNI), announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for its franchise therapeutic product, NTX-001, in the treatment of patients with peripheral nerve injuries.
Takeda Pharmaceutical has secured expanded approval from the European Commission (EC) for its Adcetris in combination with CHP (cyclophosphamide, doxorubicin, prednisone) to treat adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL), a subtype of peripheral T-cell lymphoma (PTCL).
The InPro 7100 (i) series is designed for the Chemical, Pharmaceutical, Food & Beverage and Pulp & Paper industries. The PEEK shaft material offers high resistivity against aggressive liquids and is particularly suitable for processes with frequent CIP/SIP cycles.
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