Amgen recently announced that the company submitted to the U.S. Food and Drug Administration (FDA) a supplemental Biologics License Application (sBLA) for Xgeva (denosumab). The company also seeks approval from the European Medicines Agency (EMA). Read More »
The European Medicines Agency has accepted a Marketing Authorization Application for brexpiprazole, and its review is anticipated in the second quarter of 2018. Read More »
Mylan N.V. recently released a brief statement regarding the status of its Abbreviated New Drug Application for its generic iteration of GlaxoSmithKline's Advair Diskus bronchodilator product. Read More »
AbbVie has received approval from the U.S. Food and Drug Administration to include moderate to severe fingernail psoriasis data in the Humira (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis. Read More »
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee voted 11-0 on a favorable benefit-risk ratio for Genentech's rituximab/hyaluronidase subcutaneous injections in treating certain blood cancers. Read More »
The regulatory filing of investigational IL-23p19 inhibitor tildrakizumab with the European Medicines Agency was validated last week, according to Almirall and Sun Pharmaceutical Industries. Read More »
Pfizer Inc.'s meningococcal group B vaccine TRUMENBA has received a positive opinion from the European Medicines Agency Committee for Medicinal Products for Human Use. Read More »
XELJANZ (tofacitinib citrate) has been approved by the European Commission in mono or combination therapy for rheumatoid arthritis. Read More »
Genentech's drug Rituxan was recently granted Breakthrough Therapy Designation Status by the U.S. Food and Drug Administration. Read More »
EMD Serano, the biopharmaceutical business of Merck KGaA, and Pfizer Inc. recently received approval from the U.S. Food and Drug Administration to market Bavencio Injection 20 mg/mL for intravenous use. Read More »
Shire PLC's recombinant ADAMTS13 drug, SHP655, has been given fast-track designation by the U.S. Food and Drug Administration. Read More »
Restasis MultiDose will now be available and approved by the U.S. Food and Drug Administration for help treating patients with a type of Chronic Dry Eye by helping them make more of their own tears. Read More »
The U.S. Food and Drug Administration has approved Allergan PLC’s Juvéderm Vollure XC for use correcting moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over 21. Read More »
Mylan N.V., a global pharmaceutical company, recently announced the U.S. Food and Drug Administration (FDA) tentatively approved the company's New Drug Application for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg ("TLE400"). Read More »
Amgen recently announced that the European Commission (EC) granted the company authorization to bring to market Amgevita in all available indications. Read More »
An interim final rule introduced by the Drug Enforcement Agency would result in Insys Therapeutics Inc.'s Syndros product being placed in Schedule II of the Controlled Substances Act. Read More »
Amgen recently announced positive data from the Phase 3 '482 study, which is the largest international multiple myeloma trial ever conducted. Read More »
Abbot recently announced that the U.S. Food and Drug Administration (FDA) approved its FlexAbility Ablation Catheter. Read More »
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Pfizer Inc.'s combination antibiotic Zavicefta is now available in the United Kingdom and Germany for the treatment of Gram-negative bacterial infections requiring hospitalization. Read More »
The U.S. Food and Drug Administration has accepted a supplemental New Drug Application for Auryxia tablets from Keryx Biopharmaceuticals Inc., a company specializing in innovative medicines to fight renal disease. Read More »
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