The Pharmaceutical Care Management Association (PCMA) has recommended that the next Food and Drug Administration (FDA) director adopt five specific strategies to encourage pharmaceutical pricing competition based on results of its recently commissioned report. Read More »
EMD Serono, the biopharmaceutical business of Merck KGaA and Pfizer Inc., recently announced that the Biologics License Application (BLA) for their avelumab drug was accepted for Priority Review by the U.S. Food and Drug Administration (FDA). Read More »
Bracco Diagnostics, the U.S. subsidiary of Bracco Imaging, has had its Varibar Pudding product approved by the U.S. Food and Drug Administration. Read More »
The American Society of Health-System Professionals recently announced that the United States updated the Common Rule, a federal regulation that supports research involving human subjects. Read More »
ALK's house dust mite (HDM) sublingual allergy immunotherapy tablet has been approved in 12 European countries, to include availability for adolescent patients. Read More »
The U.S. Food and Drug Administration has approved two applications for treatments of hepatitis C in children. Read More »
Ingrezza (valbenazine) has been approved by the Food and Drug Administration for the treatment of tardive dyskinesia in adults. Read More »
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 Inc. recently announced that its Toca 511 & Toca FC drug received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. Read More »
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 »
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, 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'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 »
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 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 »
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 »
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 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 »
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