Janssen Gets Two Positive CHMP Opinions For Darzalex Subcutaneous Formulation Utilizing Enhanze
NEW BRUNSWICK (dpa-AFX) - Janssen Pharmaceutica received two positive opinions from the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA recommending to broaden the existing marketing authorization for the DARZALEX or daratumumab subcutaneous formulation, which uses ENHANZE technology, in two new indications, Halozyme Therapeutics Inc. (HALO) said in a statement.
One recommendation is for the use in combination with cyclophosphamide, bortezomib and dexamethasone, for the treatment of adult patients with newly diagnosed systemic light chain amyloidosis.
The second recommendation is for the use of daratumumab subcutaneous in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refract
PTA-Adhoc: CO DON AG: EU-weit zugelassenes Arzneimittel erhält Votum für Indikationserweiterung zum Einsatz bei Jugendlichen
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Avis positif de l Agence européenne des médicaments pour le traitement anti-covid Sotrovimab à base d anticorps monoclonaux
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NanoViricides Has Filed Quarterly Report for Period Ending March 31, 2021 - Has Sufficient Cash, Coronavirus Drug Candidate Moving Towards IND
ACCESSWIRE
17 May 2021, 20:55 GMT+10
SHELTON, CT / ACCESSWIRE / May 17, 2021 / NanoViricides, Inc. (NYSE American:NNVC) (the Company ) a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform (the Company ), has filed its quarterly report for its third quarter of financial year 2021 with the Securities and Exchange Commission. This press release should be read in conjunction with the Company s Form 10-Q filed on May 14, 2021. The submission can be downloaded from the SEC website at: https://www.sec.gov/Archives/edgar/data/1379006/000110465921066909/tm2111798d1 10q.htm.