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Strides gets USFDA approval for Prednisone Tablets expresspharma
February 18, 2021
Prednisone is a corticosteroid used as an anti-inflammatory or an immunosuppressant medication to treat different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.
FDA Approves BMS CAR-T Cell Therapy contractpharma
February 10, 2021
Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of relapsed or refractory large B-cell lymphoma.
USFDA awards Breakthrough Therapy designation to Novartis’ asciminib pharmaceutical-business-review
February 10, 2021
Novartis has announced that the novel investigational treatment asciminib, specifically targeting the ABL myristoyl pocket (STAMP), has been awarded Breakthrough Therapy designation (BTD) by the US Food and Drug Administration (FDA).
FDA Approves TEPMETKO for Metastatic Non-Small Cell Lung Cancer americanpharmaceuticalreview
February 10, 2021
The U.S. Food and Drug Administration (FDA) approved TEPMETKO (tepotinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymalepithelial transition (MET) exon 14 skipping alterations.
Lupin gets US FDA nod for Tavaborole Topical Solution expresspharma
February 10, 2021
It is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
Freeline modifies clinical development plan for Hemophilia B programme pharmaceutical-technology
February 10, 2021
Clinical-stage biotechnology company Freeline Therapeutics has announced a modification to the clinical development plan for its FLT180a programme for Hemophilia B.
AbCellera gets EUA from US FDA for its antibody Bamlanivimab, along with Etesevimab for COVID-19 expresspharma
February 10, 2021
Lilly plans to manufacture more than 250,000 doses of the bamlanivimab and etesevimab therapy throughout Q1 2021, and up to a million doses by mid-2021.
FDA approves third gene therapy for large B-cell lymphoma europeanpharmaceuticalreview
February 09, 2021
Breyanzi (lisocabtagene maraleucel) was approved on the 54 percent complete remission rate achieved in diffuse large B-cell lymphoma trials.
FDA Grants Accelerated Approval to Tepotinib for Metastatic NSCLC americanpharmaceuticalreview
February 09, 2021
The U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib (Tepmetko, EMD Serono Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping ...
Rhizen Pharma’s partnered asset Umbralisib gets US FDA accelerated nod for relapsed or refractory marginal zone lymphoma, follicular lymphoma expresspharma
February 09, 2021
Umbralisib is a novel, next generation, oral, once daily, inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon, discovered by Rhizen Pharma and subsequently licensed to TG Therapeutics at an IND stage (TGR 1202) in 2012.

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