The Latest Breaking News from European Medicines Agency

Pfizer, BioNTech Seeks Emergency Use Nod For COVID-19 Vaccine For Kids 5-11 Years

Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have submitted an FDA Emergency Use Authorization (EUA) application for a 10-µg booster dose of COVID-19 Vaccine for children 5 through 11 years of age. The submission included data from the Phase 2/3 clinical trial in children ages 5 through 11 years who received a booster dose…

Benzinga · Apr 27, 2022

EMA' Advisory Committee Recommends Approval For Roche's Two Cancer Drugs

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended conditional approval for Roche Holdings AG's (OTC:RHHBY) mosunetuzumab for relapsed or refractory (R/R) follicular lymphoma (FL). The opinion covers mosunetuzumab for adult patients who have received at least two prior systemic therapies.  The CHMP recommendation is based on…

Benzinga · Apr 22, 2022

Britain Approves Moderna's COVID-19 Vaccine For Kids Aged 6-11 Years

Britain's medicines regulator approved the use of Moderna Inc's (NASDAQ:MRNA) COVID-19 vaccine in children between six and 11 years. The Medicines and Healthcare products Regulatory Agency (MHRA) said the approval was granted after Moderna's vaccine, known as Spikevax, met the required safety, quality, and effectiveness standards. Read Next: Why Did Moderna Recall Thousands Of COVID-19…

Benzinga · Apr 14, 2022

See Why Did FDA Extend Review Period For Alnylam's Vutrisiran In Amyloidosis

The FDA has extended the review timeline for Alnylam Pharmaceuticals Inc's (NASDAQ:ALNY) marketing application for vutrisiran for transthyretin-mediated (ATTR) amyloidosis. The updated Prescription Drug User Fee Act (PDUFA) goal date is July 14. The FDA needs additional time to review newly added information related to the new secondary packaging and labeling facility for investigational RNAi…

Benzinga · Apr 4, 2022

Novavax asks EU regulator to clear COVID vaccine for teens

The pharmaceutical developer Novavax says it has asked the European Medicines Agency to extend the authorization of its coronavirus vaccine to children aged 12 to 17 amid a surge of disease across the continent

The Independent UK · Mar 31, 2022

EMA Starts Review Of Sanofi-GlaxoSmithKline's COVID-19 Vaccine

The European Medicines Agency has started reviewing Sanofi SA (NASDAQ:SNY) and its partner GlaxoSmithKline Plc's (NYSE:GSK) application seeking conditional authorization for their COVID-19 vaccine. The vaccine candidate, Vidprevtyn, was already being evaluated under a rolling review by EMA. The drugmakers had earlier said that they would seek regulatory approval for their COVID-19 vaccine to be…

Benzinga · Mar 30, 2022

Novartis Receives Positive CHMP Opinion For Kymriah In Follicular Lymphoma, Jakavi In GvHD

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Novartis AG's (NYSE: NVS) 

Benzinga · Mar 25, 2022

EMA's CHMP Clears Janssen, Legend's Multiple Myeloma CAR-T Therapy

The European Medicines Agency's CHMP 

Benzinga · Mar 25, 2022

EMA's Advisory Group Backs Approval For Merck's Keytruda In Various Cancer Settings

The European Medicines Agency's advisory group CHMP has adopted a positive opinion recommending approval of Merck & Co Inc (NYSE: MRK) for 

Benzinga · Mar 25, 2022

FDA Approves Novartis' Pluvicto As First Targeted Radioligand Therapy For Prostate Cancer

The FDA approved Novartis AG's (NYSE:NVS) Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to treat patients with a type of advanced prostate cancer that has spread to other parts of the body. Pluvicto is a targeted radioligand therapy for adult patients who have already undergone other anticancer treatments. The company said it had submitted…

Benzinga · Mar 24, 2022