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July 10, 2019
FDA released draft guidance on using the USP pending monograph process in the drug application process.
July 02, 2019
CHMP of the European Medicines Agency has recommended a change to the European marketing authorization for AstraZeneca’s Forxiga (dapagliflozin) in patients with Type-2 diabetes.
AstraZeneca has revealed that the CHMP of the European Medicines Agency has given a positive opinion to adding a self-administration option for Fasenra (benralizumab).
Will EMA’s draft guideline clarify questions about the assessment of drug device combinations in relation to the EU medical devices regulation?
July 01, 2019
FDA approved first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system.
June 28, 2019
CHMP has recommended that the indication of Victoza (liraglutide) be extended to include its use in pediatric patients with Type 2 diabetes.
June 24, 2019
The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.
June 20, 2019
The draft guidance describes a benefit-risk assessment framework for evaluating applications for opioid analgesic drugs.
June 19, 2019
The agency is adding data points to its Paragraph IV Patent Certifications List, which provides brand exclusivity information, in order to help generic-drug applicants determine if their product can be approved and marketed.
June 14, 2019
SenzaGen has revealed that is has been granted a patent in Europe for GARDpotency, a testing application that enables the measurement of the allergenicity of chemical substances without animal research.