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 »
Bavencio treatment for Merkel cell carcinoma patients gains FDA approval
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 »
FDA fast-tracks Shire's SHP655 for patients with ADAMTS13
Shire PLC's recombinant ADAMTS13 drug, SHP655, has been given fast-track designation by the U.S. Food and Drug Administration. Read More »
Allergan to sell FDA-approved Restasis in first multi-dose bottle
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 »
Allergan's Juvéderm Vollure XC approved for sale in the U.S.
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 »
FDA tentatively OKs Mylan's HIV/AIDS drug for developing nations
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 receives European approval to market Amgevita
Amgen recently announced that the European Commission (EC) granted the company authorization to bring to market Amgevita in all available indications. Read More »
DEA rule would classify Syndros drug as controlled substance
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 »
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