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Aridis Receives Orphan Drug Designation from the EMA for AR-501 americanpharmaceuticalreview
July 22, 2019
ridis Pharmaceuticals announced the European Medicines Agency (EMA) has granted Orphan Drug Designation to AR-501, the Company's inhaled formulation of gallium citrate for treatment of lung infection in patients with cystic fibrosis.
Blueprint Medicines Announces EMA Validation for Avapritinib americanpharmaceuticalreview
July 22, 2019
Blueprint Medicines announced the European Medicines Agency (EMA) has validated the company's Marketing Authorization Application (MAA) for avapritinib for the treatment of adult patients with PDGFRα D842V mutant gastrointestinal stromal tumors (GIST) ...
EMA releases medicinal approval recommendations europeanpharmaceuticalreview
July 05, 2019
The EMA has given its approval recommendation to three drugs and announced negative opinions for approval on others.
Amgen, UCB Receives Negative Opinion on EMA Application EVENITY™ in EU americanpharmaceuticalreview
July 01, 2019
Amgen and UCB announced the companies have been informed the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on ...
Sophiris Bio Receives Positive Feedback from EMA Regarding Prostate Cancer Clinical Trial Design americanpharmaceuticalreview
June 21, 2019
Sophiris Bio has received formal scientific advice from the European Medicines Agency (EMA) regarding a proposed design of a Phase 3 clinical trial to evaluate the potential of topsalysin as a targeted focal therapy to treat patients with intermediate ris
US FDA and EMA Accept Applications for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis drugs
June 11, 2019
US FDA and EMA Accept Applications for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis.
GSK gets positive opinion for Nucala self-administration from EMA pharmaceutical-technology
June 06, 2019
GlaxoSmithKline (GSK) has secured a positive recommendation from a European Medicines Agency (EMA) panel for its Nucala (mepolizumab) medication.
EMA accepts Prestige Biopharma's MAA for review biospectrumasia
May 29, 2019
HD201 is Prestige’s first biosimilar to receive a positive Committee for Medicinal Products for Human Use (CHMP) opinion for marketing authorization from the EMA.
EMA’s PRAC to review Xeljanz and recommends fenspiride withdrawl pharmatimes
May 20, 2019
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has announced its latest meeting highlights, including a restriction of the use of Xeljanz (tofacitinib), and a call for withdrawal of marketing authorisations for fe
Long-lasting opioid treatment recommended by an EMA committee europeanpharmaceuticalreview
May 05, 2019
Marketing authorisation has been recommended in the EU by an EMA committee for Sixmo (buprenorphine) as a substitution treatment for opioid dependence.

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