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Pfizer and BioNTech initiate rolling submission for Covid-19 vaccine pharmaceutical-technology
October 10, 2020
Pfizer and BioNTech have initiated a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the vaccine candidate against Covid-19.
Pacira Receives Positive CHMP Opinion for EXPAREL for Postsurgical Pain americanpharmaceuticalreview
September 27, 2020
Pacira BioSciences announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for EXPAREL for postsurgical analgesia.
FDA and EMA accept regulatory submissions for UCB’s bimekizumab pharmatimes
September 27, 2020
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both accepted marketing application submissions for UCB’s psoriasis treatment bimekizumab.
CHMP backs seven new meds in September meeting pharmatimes
September 22, 2020
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines for approval in its latest meeting.
EMA safety committee recommends withdrawal of ulipristal acetate marketing authorisation europeanpharmaceuticalreview
September 18, 2020
The EMA’s PRAC has recommended the revocation of the marketing authorisation for ulipristal acetate, after a review confirmed liver injury caused by the medicine.
GenSight Biologics seeks EU approval for gene therapy pharmatimes
September 17, 2020
French biopharma company Gensight Biologics has submitted a marketing authorisation application for its lead gene therapy Lumevoq to the European Medicines Agency (EMA).
EMA approves label update for Takeda’s HYQVIA, expands use to treat secondary immunodeficiencies expresspharma
September 16, 2020
It was based on evidence from clinical trials that demonstrated that subcutaneous administration of immunoglobulin has been shown to decrease the rate of infections in patients with SID.
EMA begins review of Dexamethasone Taw for COVID-19 pharmatimes
September 07, 2020
The European Medicines Agency (EMA) has begun evaluating an application for the authorisation of Dexamethasone Taw for treating adults hospitalised with COVID-19.
EMA accepts marketing application for Spinal Muscular Atrophy treatment europeanpharmaceuticalreview
August 20, 2020
The European Medicines Agency (EMA) has accepted the marketing authorisation application for Evrysdi™ (risdiplam) as a treatment of spinal muscular atrophy (SMA).
EMA initiates review of dexamethasone for treating COVID-19 europeanpharmaceuticalreview
July 29, 2020
The EMA has begun to review dexamethasone to provide an opinion on the results of the RECOVERY study for the treatment of adults admitted to hospital with COVID-19.

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