BioSpace News Archive

ARS Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion on the application for marketing authorization for EURneffy® and recommended related market authorization in the European Union for the emergency treatment of allergic reactions.

Merck announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of WINREVAIR.

NovaBay Pharmaceuticals, Inc. announces it will be offering special promotions and discounts on its Avenova®-branded eyecare products to customers and eyecare professionals throughout July in support of National Dry Eye Awareness Month.

Regeneron Pharmaceuticals, Inc. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.

23andMe Holding Co. and Nightingale Health Plc announced a strategic collaboration to pilot Nightingale Health’s clinically-validated and cost-effective blood metabolomics panel with a cohort of 23andMe members.

Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, announced a number of updates pertaining to the advancement of universal newborn screening for metachromatic leukodystrophy.

Eliem Therapeutics, Inc. (Nasdaq: ELYM), announced today that the Company will be included in the Russell 2000® Index and the broad-market Russell 3000® Index, as part of the annual reconstitution of the Russell stock indexes, effective today.

Iovance Biotherapeutics, Inc. submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for lifileucel, a TIL cell therapy, for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

Apellis Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion on the marketing authorization application of intravitreal pegcetacoplan for the treatment of geographic atrophy.

IASO Biotechnology (“IASO Bio”) today announces that the investigational new drug (IND) application for RD118, an independently developed, fully human GPRC5D-targeting chimeric antigen receptor T-cell (CAR-T) therapy, has been approved by the National Medical Products Administration (NMPA) for treatment of relapsed/refractory multiple myeloma (RRMM).