FDA approves Ingrezza to treat tardive dyskinesia
Ingrezza (valbenazine) has been approved by the Food and Drug Administration for the treatment of tardive dyskinesia in adults. Read More »
AbbVie's Phase IIb study on elagolxi shows positive results
AbbVie shared the successful results of its Phase IIb clinical trial on elagolix on patients suffering from heavy menstrual bleeding due to fibroids last week. Read More »
Tocagen receives FDA Breakthrough Therapy Designation for HGG drug
Tocagen Inc. recently announced that its Toca 511 & Toca FC drug received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. Read More »
Dupixent drug approved by FDA for atopic dermatitis treatment
Sanofi and Regeneron Pharmaceuticals Inc.'s Dupixent injection has been approved by the U.S. Food and Drug Administration (FDA) for use treating adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies. Read More »
Initiative launched to make HBCUs smoke- and tobacco-free
The Truth Initiative and CVS Health Foundation have launched an initiative to combat tobacco use at historically black colleges and universities (HBCUs). Read More »
Alcon receives FDA approval for AcrySof intraocular lenses
Alcon, a division of Novartis, has received approval from the U.S. Food and Drug Administration for its AcrySof IQ ReSTOR +2.5 Multifocal Toric intraocular lens with ActiveFocus optical design. The product was made for patients with an astigmatism and presbyopia who want to treat them both at the same time with cataract surgery. Read More »
Genentech receives FDA approval to market Ocrevus
Genentech's Ocrevus, the only medicine capable of treating both relapsing and primary progressive forms of multiple sclerosis, has been approved by the U.S. Food and Drug Administration. Read More »
FDA grants priority review for Bristol-Myers' Opdivo sBLA
The U.S. Food and Drug Administration (FDA) has granted Bristol-Myers Squibb Co. a priority review for the company’s Opdivo Biologics License Application. Read More »
AbbVie's Imbruvica sNDA accepted for review by FDA
AbbVie's supplemental new drug application for ibrutinib, a product for treating chronic graft vs. host disease (cGVHD) after failure of one or more lines of systemic therapy, has received FDA approval. Read More »
FDA approves application for breast cancer drug from Pfizer
Pfizer Inc.'s supplemental New Drug Application (sNDA) for Ibrance, its first-in-class cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, has been approved by the U.S. Food and Drug Administration. Read More »
Teva drug approved to ease chorea in Huntington's patients
To treat some of Huntington disease’s harshest symptoms and help restore quality of life to those suffering from the rare, fatal neurodegenerative disease, the U.S. Food and Drug Administration recently approved a medication created by Teva Pharmaceutical Industries. Read More »
Amgen files requests to expand Xgeva's use in U.S. and Europe
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 »
Review of brexpiprazole anticipated by European authority
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 comments on Advair Diskus ANDA status
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 »
FDA approves fingernail psoriasis data for Humira
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 »
FDA approves benefit-risk ratio for Genentech blood cancer drug
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 »
Tildrakizumab filing with European agency validated
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's TRUMENBA moves closer to European approval
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 »
European Commission approves XELJANZ for rheumatoid arthritis
XELJANZ (tofacitinib citrate) has been approved by the European Commission in mono or combination therapy for rheumatoid arthritis. Read More »
Rituxan receives breakthrough status from FDA
Genentech's drug Rituxan was recently granted Breakthrough Therapy Designation Status by the U.S. Food and Drug Administration. Read More »
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