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Sandoz Inc., a division of Novartis (NVS), and Pear Therapeutics Inc. announced that the U.S. Food and Drug Administration has granted clearance for reSET-O. reSET-O is intended to increase retention of patients with Opioid Use Disorder or OUD in outpatient treatment by providing cognitive behavioral...

Bausch + Lomb, a subsidiary of Bausch Health Companies Inc. (BHC), announced that it has received 510(k) clearance from the U.S. FDA for Bausch + Lomb ULTRA Multifocal for Astigmatism contact lenses, the first multifocal toric lens to be available as a standard offering in the eye care professional's...

Genentech, a member of the Roche Group (RHHBY), announced Wednesday that the U.S. Food and Drug Administration or FDA has granted priority review to Tecentriq in combination with Chemotherapy for the initial treatment of extensive-stage small cell lung cancer or ES-SCLC. The FDA has accepted the company's...

Gilead Sciences Inc. (GILD) announced that the China National Medical Products Administration or NMPA has approved Descovy ---emtricitabine 200 mg/tenofovir alafenamide 10 mg and emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF---, a fixed-dose combination for the treatment of HIV. In China,...

The first test to aid in detecting cytomegalovirus, a type of herpes virus, in newborns has received the FDA go-ahead.

Swiss drug major Novartis AG (NVS) announced Monday that the U.S. Food and Drug Administration has accepted the company's Biologics License Application or BLA for AVXS-101, now known as ZOLGENSMA (onasemnogene abeparvovec- xxxx), an investigational gene replacement therapy for the treatment of spinal...

United Therapeutics Corp. (UTHR) announced that Health Canada has approved Unituxin or dinutuximab for injection, in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2, and 13-cis-retinoic acid, for the treatment of high-risk neuroblastoma in pediatric patients who achieve...

Swiss drug major Novartis AG (NVS) announced Thursday that the European Commission has approved Gilenya (fingolimod) for the treatment of children and adolescents 10 to 17 years old with relapsing-remitting forms of multiple sclerosis or RRMS. The European market authorization makes Gilenya the first...

The U.S. Food and Drug Administration said it approved Truxima or rituximab-abbs as the first biosimilar to Rituxan or rituximab for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin's lymphoma or NHL to be used as a single agent or in combination with chemotherapy. Truxima is...

Astellas Pharma Inc. (ALPMY, ALPMY) said that the U.S. Food and Drug Administration approved Xospata -- generic name: gilteritinib -- for the treatment of adult patients who have relapsed or refractory Acute Myeloid Leukemia or AML with a FLT3 mutation as detected by an FDA-approved test. Xospata...

Sandoz, a Novartis division (NVS), said that the European Commission granted marketing authorization for biosimilar Ziextenzo or pegfilgrastim. Ziextenzo is indicated to reduce the duration of neutropenia and incidence of febrile neutropenia in adult patients treated with cytotoxic (anti-cancer) chemotherapy...

The U.S. Food and Drug Administration said it granted accelerated approval to Vitrakvi or larotrectinib, a treatment for adult and pediatric patients whose cancers have a specific genetic feature, biomarker. The FDA granted the approval of Vitrakvi to Loxo Oncology (LOXO). Vitrakvi is indicated for...

British drug major AstraZeneca (AZN.L, AZN) announced Monday that the US Food and Drug Administration or FDA has granted Orphan Drug Designation or ODD for Fasenra (benralizumab) for the treatment of Eosinophilic Granulomatosis with Polyangiitis or EGPA. EGPA is a rare autoimmune disease that can...

Indivior PLC (INDV.L) announced Friday that Health Canada has approved SUBLOCADE (buprenorphine extended-release) injection for patients with moderate to severe opioid use disorder or OUD. It is for the use in adult patients who have been inducted and clinically stabilized on a transmucosal buprenorphine-containing...

Novartis (NVS) said that the European Commission approved Luxturna, a one-time gene therapy for the treatment of patients with vision loss due to a genetic mutation in both copies of the RPE65 gene and who have enough viable retinal cells. The authorization is valid in all 28 member states of the EU,...

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