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FDA Approves GAVRETO for Metastatic Rearranged During Transfection Fusion-Positive NSCLC americanpharmaceuticalreview
September 16, 2020
The U.S. Food and Drug Administration (FDA) approved GAVRETO (pralsetinib) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
US FDA denies approval to Mallinckrodt for Terlipressin to treat Hepatorenal Syndrome Type 1 expresspharma
September 16, 2020
The Complete Response Letter stated that, based on the available data, the agency cannot approve the terlipressin NDA in its current form and requires more information to support a positive risk-benefit profile for terlipressin for patients with HRS-1.
Indoco gets USFDA nod for apixaban tablets expresspharma
September 15, 2020
Apixaban is an anticoagulant, or blood thinner used for patients with health problems caused by a blood clot.
FDA Grants Orphan Drug Designation for Prosthetic Joint Infections Treatment americanpharmaceuticalreview
September 14, 2020
Peptilogics has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for PLG0206, the company's first-in-class, broad-spectrum antibiotic peptide, for the treatment of prosthetic joint infections (PJI) ...
FDA Announces Efficacy, Safety Concerns with Breast Cancer Treatment americanpharmaceuticalreview
September 14, 2020
The U.S. Food and Drug Administration (FDA) is alerting health care professionals, oncology clinical investigators, and patients that a clinical trial studying the use of atezolizumab (Tecentriq) and paclitaxel in patients with previously untreated ...
Junshi Biosciences gets US FDA Breakthrough Therapy Designation for Toripalimab to treat nasopharyngeal carcinoma expresspharma
September 14, 2020
Chinese firm, Junshi Biosciences announced that the US Food and Drug Administration (FDA) has recently granted Breakthrough Therapy designation (BTD) to Toripalimab for the treatment of nasopharyngeal carcinoma.
Zydus Cadila gets US FDA approval for Doxorubicin Hydrochloride Liposome Injection expresspharma
September 14, 2020
Liposomal doxorubicin is a chemotherapeutic agent that is used alone or with other treatments/medications to treat certain types of cancer like ovarian cancer, AIDS-related Kaposi’s sarcoma and multiple myelom.
Alembic Pharma gets tentative USFDA approval for Treprostinil injection expresspharma
September 08, 2020
It is indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise.
Dr Reddy’s Laboratories launches Fulvestrant Injection in US expresspharma
September 08, 2020
Fulvestrant is an estrogen receptor antagonist indicated for the treatment of HR-positive advanced breast cancer.
Intercept to Cut 25% of Workforce after NASH Treatment Rejection from FDA americanpharmaceuticalreview
September 07, 2020
Intercept Pharmaceuticals plans to lay off 25% of its workforce, approximately 170 jobs, after its nonalcoholic steatohepatitis (NASH) treatment application for obeticholic acid (OCA) was rejected by the U.S. Food and Drug Administration (FDA).

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