European Medicines Agency (EMA)

European Medicines Agency (EMA) will request further clarifications from drugmakers of GLP-1 receptor agonists for diabetes and weight loss, including Novo Nordisk A/S's (NYSE: NVO) popular therapies Ozempic and Wegovy, to investigate suicidal thoughts further. "While at...

Health Canada has approved Moderna Inc's (NASDAQ: MRNA) omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), as a booster dose for individuals 18 years of age and older.  A booster dose of mRNA-1273.214 increased...

At a press briefing, the European Medicines Agency (EMA) said it is open to using updated COVID-19 vaccines that target older omicron variants this Fall, amid a rise in cases due to new omicron subvariants. The agency notes that the existing vaccines provide good protection against hospitalization...

European Medicines Agency concluded that it is too early to consider using the fourth dose of either Pfizer Inc (NYSE: PFE) / BioNTech SE (NASDAQ: BNTX) or Moderna Inc's (NASDAQ: MRNA) mRNA COVID-19 vaccine in the general population. However, the EU...

Deciphera Pharmaceuticals Inc (NASDAQ: DCPH) announced four e-poster presentations at the European Society for Medical Oncology (ESMO21) Virtual Conference 2021.  The presentations include updated preliminary results from the ongoing Phase 1b/2 study of rebastinib plus paclitaxel in...

The European Medicines Agency (EMA) Committee for Orphan Medicinal Products has issued a positive opinion on Akouos Inc's (NASDAQ: AKUS) application for orphan drug designation for AK-OTOF. AK-OTOF is a gene therapy intended for the treatment of otoferlin gene-mediated...

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Moderna Inc's (NASDAQ: MRNA) COVID-19 vaccine (Spikevax) for use in adolescents 12 years of age and older. Following the CHMP...

The European Commission (EC) has approved Merck & Co Inc's  (NYSE: MRK) soluble guanylate cyclase (sGC) stimulator Verquvo (vericiguat).  Verquvo (2.5 mg, 5 mg, and 10 mg) is indicated to treat symptomatic chronic heart failure in adult patients with reduced...

On Tuesday, the European Medicines Agency (EMA) said it was analyzing data on rare cases of a nerve disorder reported among recipients of Johnson & Johnson's (NYSE: JNJ) COVID-19 shot, Reuters reported. The FDA issued a warning that there are data "...

The European Commission has approved Roche Holding AG's (OTC: RHHBY) injectable Enspryng for adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD). The approval for the treatment comes as a monotherapy or in combination with immunosuppressive therapy. ...

The European Medicines Agency (EMA) has granted orphan drug designation to Stealth BioTherapeutics Corp's (NASDAQ: MITO) elamipretide for Barth syndrome, an ultra-rare genetic condition. Barth syndrome is characterized by cardiac abnormalities, often leading to heart...

Seelos Therapeutics Inc's (NASDAQ: SEEL) Trehalose (SLS-005) has received Orphan Drug Designation for amyotrophic lateral sclerosis (ALS) from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP). Under the orphan designation, Seelos stands to...

The European Commission has approved Janssen's, a unit of Johnson & Johnson (NYSE: JNJ) Ponvory (ponesimod), to treat adult patients with relapsing multiple sclerosis. The EC approval of ponesimod is based on data from the Phase 3 OPTIMUM trial that met the primary endpoint...

Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval for Merck & Co Inc's (NYSE: MRK) Keytruda (pembrolizumab) combined with chemotherapy for esophageal cancer. The...

The European Medicines Agency (EMA) has granted its request for accelerated assessment review to BioMarin Pharmaceutical Inc’s (NASDAQ: BMRN) valoctocogene roxaparvovec, gene therapy to treat severe hemophilia A, with an opinion expected in the first half of 2022,...