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April 18, 2019
The agency provides recommendations for the development of bispecific antibody development programs that include regulatory, quality, nonclinical, and clinical considerations.
April 17, 2019
Sharpless will seek further solutions to the opioid crisis and work to reduce cigarette use in adults and kids.
April 16, 2019
FDA sent a warning letter to RIJ Pharmaceutical LLC after an inspection of the company’s Middletown, NY facility found CGMP violations.
The agency sent a warning letter to Luen Fook Medicine Sdn., Bhd. for CGMP violations found at the company’s Malaysia facility.
April 15, 2019
EMA is evaluating the safety of Lemtrada (alemtuzumab) after new side effects were reported.
April 12, 2019
NICE has not recommended the use of Novartis’ Kisqali (ribociclib) in combination with fulvestrant for the treatment of hormone receptor-positive, HER2-negative, advanced breast cancer.
April 11, 2019
The European Medicines Agency weighs in on the role of regulators in determining added benefits of novel therapies.
April 09, 2019
FDA Commissioner Scott Gottlieb and Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, expect shortages to ease within six months. Although recycled solvents and materials are a prime concern, questions remain about the sources of contamination.
The agency approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato.
April 05, 2019
The EU has announced that it has launched two WTO cases on unlawful import duties on ICT products and unlawful measures on pharmaceuticals, against India and Turkey, respectively.