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Boston Scientific Corp.'s (BSX) shares gained around 2 percent in the extended trading on Tuesday after the company announced it has received U.S. Food and Drug Administration approval for the LOTUS Edge Aortic Valve System. The transcatheter aortic valve replacement or TAVR technology is delivered...

skyrizi-april24.jpg The therapeutic armamentarium for plaque psoriasis patients is fairly well-stocked, and now there is one more addition to it.

pharma-033017_22apr19.jpg The first medical device to treat attention deficit hyperactivity disorder, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, has been given clearance by the FDA.

Merck (MRK) announced the U.S. FDA has approved KEYTRUDA in combination with Inlyta for the first-line treatment of patients with advanced renal cell carcinoma. Inlyta (axitinib) is a tyrosine kinase inhibitor. The approval was based on data from the pre-specified interim analysis of a phase 3 KEYNOTE-426...

AstraZeneca Plc (AZN.L, AZN) and Merck & Co., Inc. (MRK) announced Wednesday that the European Commission has approved Lynparza (olaparib) as a monotherapy for the treatment of adult patients with germline BRCA1/2-mutations or gBRCAm, and who have human epidermal growth factor receptor 2 (HER2)-negative...

GlaxoSmithKline plc (GSK.L, GSK) reported that ViiV Healthcare announced the US FDA approved Dovato, a once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known resistance...

Shares of Zogenix Inc. (ZGNX) plunged in the Monday after-hours trade, following announced that the company received a Refusal to File letter from the U.S. Food and Drug Administration regarding its New Drug Application for FINTEPLA or ZX008, fenfluramine hydrochloride for the treatment of seizures...

Pfizer (PFE) said that the U.S. Food and Drug Administration approved a supplemental New Drug Application or sNDA to expand the indications for IBRANCE or palbociclib in combination with an aromatase inhibitor or fulvestrant to include men with hormone receptor-positive or HR+, human epidermal growth...

ADMA Biologics, Inc. (ADMA) said that the U.S. Food and Drug Administration has approved Asceniv, Immune Globulin Intravenous, Human - slra 10% Liquid, formerly referred to as RI-002. ASCENIV is an Intravenous Immune Globulin or "IVIG" drug product for the treatment of Primary Humoral Immunodeficiency...

AstraZeneca Plc (AZN.L, AZN) announced Thursday that the US Food and Drug Administration has granted Breakthrough Therapy Designation or BTD for the MEK 1/2 inhibitor and potential new medicine selumetinib. This designation is for the treatment of paediatric patients aged three years and older with...

AstraZeneca Plc (AZN.L, AZN) announced Wednesday that Forxiga has received approval in Japan for Type-1 Diabetes or T1D. The Japanese Ministry of Health, Labour and Welfare or MHLW has approved Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with T1D. The approval is...

Novartis (NVS) said that the US Food and Drug Administration has approved Mayzent or siponimod for the treatment of adults with relapsing forms of multiple sclerosis, including secondary progressive multiple sclerosis or SPMS with active disease, relapsing remitting multiple sclerosis or RRMS and clinically...

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