Amgen's Repatha approved for single-dose delivery option in Europe
The European Commission has adopted a decision to change the Repatha (evolocumab) marketing authorization, approving a new single-dose delivery option. Read More »
New medication from Teva available for asthma treatment
Teva Pharmaceutical Industries Ltd. has launched AirDuo RespiClick, an inhalation powder for the treatment of asthma in patients 12 and older. Read More »
European authorities grant Shire's Natpar approval for human use
Shire PLC's Natpar, an adjunctive treatment for adult patients with chronic hypoparathyroidism, was reviewed positively by the Committee for Medicinal Products for Human Use of the European Medicines Agency. Read More »
PCMA urges FDA to consider competitive drug pricing
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 »
FDA grants priority review to carcinoma drug
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 receives FDA approval for Varibar Pudding
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 »
Update to Common Rule could impact research on human subjects
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 dust mite medication approved for use by adolescents in Europe
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 »
FDA OKs applications for hepatitis C treatment in children
The U.S. Food and Drug Administration has approved two applications for treatments of hepatitis C in children. Read More »
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 »
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