The Latest Breaking News from European Medicines Agency

The U.S. Food and Drug Administration (FDA) has approved Incyte’s (NASDAQ:INCY) Pemazyre (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. Incyte shares traded in a range of $71.38 to $72.98 on day volume of 1.25…

Pharmaceuticals Pfizer and BioNTech say they have asked the European Medicines Agency to authorize their updated coronavirus booster vaccine that includes the most recent omicron subvariants

The European Medicines Agency said a smaller dose of the monkeypox vaccine appears to still be effective and can be used to stretch the current supply by five times, echoing a recommendation made earlier this month by the U.S. Food and Drug Administration

The US Food and Drug Administration (FDA) has accepted for filing Krystal Biotech’s (NASDAQ:KRYS) Biologics License Application (BLA) for its lead candidate B-VEC in the treatment of patients with dystrophic epidermolysis bullosa (DEB). The regulatory agency has granted  Priority Review designation and assigned a target actin date of February 17,…

The U.S. Food and Drug Administration (FDA) has accepted for review MediWound’s (NASDAQ:MDWD) recently re-submitted Biologics License Application (BLA) for its lead asset NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. MediWound shares traded in a range of $1.6 to $1.76 on a day…

IDEAYA Biosciences (NASDAQ:IDYA) has entered into a clinical trial collaboration and supply agreement with Amgen Inc. to evaluate the efficacy and safety of IDE397 with Amgen's AMG 193  in a Phase 1 clinical trial. IDEAYA shares traded in a range of $14.59 to $15.82 on a day volume of 130.58…

Danish biotechnology company Bavarian Nordic said on Monday the European Commission had given permission for its Imvanex vaccine to be marketed as protection against monkeypox, as recommended last week by the European Medicines Agency (EMA).

Bristol Myers Squibb (NYSE:BMY) received European Medicines Agency (EMA) Positive CHMP Opinion recommending approval for Opdualag (nivolumab and relatlimab) for treatment of patients with Unresectable or Metastatic Melanoma based on results from the Phase 2/3 RELATIVITY-047 trial. Bristol Myers shares traded in a range of $72.48 to $73.61 on a…

The European Medicines Agency says the smallpox vaccine made by Bavarian Nordic should also be authorized against monkeypox as an outbreak of the once-rare disease sickens people across Europe

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Pfizer (NYSE: PFE) and its partner, BioNTech (NASDAQ: BNTX) announced that they have completed the submission of a regulatory application to the European Medicines Agency (EMA), which seeks authorization for thei