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Janssen and Pharmacyclics have submitted an sNDA for Imbruvica for front-line treatment for chronic lymphocytic leukemia, which, if approved, would provide patients who have not been treated with an alternative to chemotherapy. Read More
The FDA’s Vaccines and Related Biological Products Advisory Committee offered nearly unanimous support of CSL’s influenza vaccine Fluad, recommending the agency approve an accelerated pathway for use in people 65 and older against influenza types A and B. Read More
The China State Council is calling for sweeping reforms of the country’s drug regulatory system, including specified timelines for deciding applications and increased public access to applications and information. Read More
Drug and biologics makers are urging the Centers for Medicare & Medicaid Services to reimburse each noninterchangeable biosimilar based on its own average sale price, saying that would avoid prescribing mix-ups and possible harm to patient care. Read More
Merck KGaA has informed the European Medicines Agency that it will apply for marketing authorization for its multiple sclerosis drug Cladribine, four years after the firm withdrew its application following a negative opinion from the Committee for Medicinal Products for Human Use. Read More
The FDA’s Vaccines and Related Biological Products Advisory Committee will meet today to discuss the safety and immunogenicity of CSL’s influenza vaccine Fluad to determine if it should be approved through an accelerated approval pathway. The vaccine is proposed for use in people 65 and older as treatment against influenza types A and B. Read More
A joint FDA advisory panel voted unanimously Friday to recommend Collegium Pharmaceutical’s Xtampza ER NDA, deciding that the possible risks related to food effects on the opioid’s efficacy were forgiving and not likely to pose serious safety challenges. Read More
Aridis Pharmaceuticals has received FDA fast track designation for its AR-301, a monoclonal antibody that is under development to treat acute pneumonia caused by certain bacteria, including multidrug-resistant MRSA strains. Read More
Drugmakers submitting an NDA or BLA with a tropical disease priority review voucher will pay a $2.7 million fee in fiscal year 2016 — a $165,000 increase over this year, which ends Sept. 30. Read More
Amgen is seeking approval for its 420 mg monthly dosage form of Repatha just over two weeks after the FDA signed off on the PCSK9 inhibitor to control low-density lipoprotein cholesterol. Read More