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India- based Sun Pharmaceutical Industries Ltd. and Sun Pharma Advanced Research Company Ltd. or SPARC announced Friday U.S. Food and Drug Administration approval of XELPROS to treat open-angle glaucoma or ocular hypertension. In India, Sun Pharma shares were gaining around 2 percent. The approval...

AstraZeneca Plc. (AZN.L, AZN) and MedImmune, its global biologics research and development arm, said that the US Food and Drug Administration has approved Lumoxiti or moxetumomab pasudotox-tdfk for the treatment of adult patients with relapsed or refractory hairy cell leukemia or HCL who have received...

Shire plc (SHP.L, SHPG), a biotech company in rare diseases, announced Wednesday that the European Commission or EC has granted Marketing Authorization for VEYVONDI [vonicog alfa, recombinant von Willebrand factor] (rVWF) for adults with von Willebrand disease or VWD. With this approval, Shire is...

DBV Technologies (DBVT), a clinical-stage biopharmaceutical company, announced Wednesday positive review by Data and Safety Monitoring Board or DSMB of Part A of Phase III study in peanut-allergic toddlers. The company said the independent DSMB completed its planned safety review of Part A of the...

Perrigo Company plc (PRGO) said that it has received final approval from the U.S. Food & Drug administration for the store brand over-the-counter (OTC) equivalent of Imodium Multi-Symptom Relief (loperamide hydrochloride and simethicone tablets, 2 mg/125 mg). The product will be packaged and marketed...

Eisai Co., Ltd. and Merck (MRK) said that the China National Medical Products Administration or NMPA approved the kinase inhibitor LENVIMA or lenvatinib as a single agent for the treatment of patients with unresectable hepatocellular carcinoma or HCC who have not received prior systemic therapy. In...

Puma Biotechnology Inc. (PBYI) said that the European Commission has granted marketing authorisation for NERLYNX or neratinib for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from...

French drug giant Sanofi SA (SNYNF, SNY) announced Monday that the European Commission has granted marketing authorization for Cablivi (caplacizumab) for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura or aTTP, a rare blood-clotting disorder. Cablivi is...

Merck & Co. Inc. (MRK) said that the U.S. Food and Drug Administration has approved two new HIV-1 medicines, Delstrigo and Pifeltro. The company said that Delstrigo is once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF,...

Bayer (BAYZF.PK, BAYRY.PK, BYR.L) said that the United States Food and Drug Administration has approved Jivi or BAY94-9027 for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older in the U.S. The recommended initial prophylactic regimen...

British drug major AstraZeneca plc (AZN.L, AZN) announced Thursday that the European Commission has approved new easy-to-use, once-weekly Bydureon BCise device for patients with type-2 diabetes. Bydureon BCise (exenatide 2mg prolonged-release suspension for injection in pre-filled pen) is approved...

Amgen (AMGN) said that the European Commission has approved an expanded indication for BLINCYTO (blinatumomab) as monotherapy for the treatment of pediatric patients aged one year or older with Philadelphia chromosome-negative CD19 positive B-cell precursor acute lymphoblastic leukemia or ALL, which...

Novartis (NVS) said that the European Commission has approved Tafinlar or dabrafenib in combination with Mekinist or trametinib for the adjuvant treatment of stage III patients with BRAF V600 mutation-positive melanoma after complete surgical resection. The approval is the third for Tafinlar in combination...

Oxford BioMedica plc (OXB.L) said that the European Commission has approved the Novartis CAR-T cell therapy, Kymriah (tisagenlecleucel, formerly CTL019. The approved indications are for the treatment of paediatric and young adults up to 25 years of age with B-cell acute lymphoblastic leukaemia that is...

Roche (RHHBY) announced approval from the U.S. FDA for the cobas EGFR Mutation Test v2 as a companion diagnostic test with IRESSA. The cobas EGFR Mutation Test v2 is currently the only FDA-approved diagnostic test for non-small cell lung cancer using liquid biopsy. IRESSA (gefitinib) is a targeted...

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