The FDA approves Emergent BioSolutions' sBLA seeking a label expansion of ACAM2000 for the mpox indication. Stock rises in pre-market trading.
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BAAR, Switzerland — Stallergenes Greer, a leading global healthcare company specialising in allergen immunotherapy, today announced that the U.S Food and Drug Administration (FDA) has approved Palforzia® [Peanut (Arachis hypogaea) Allergen Powder-dnfp], for the treatment of toddlers (ages 1-3 years) with a confirmed diagnosis of a peanut allergy. This approval expands the January 2020 FDA […]
The FDA approves Emergent BioSolutions' sBLA seeking a label expansion of ACAM2000 for the mpox indication. Stock rises in pre-market trading.
GAITHERSBURG, Md., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration...
GAITHERSBURG, Md., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration...
CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--Sep. 3, 2024-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that the U.S....
REDWOOD CITY, Calif., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical...
Immune checkpoint inhibitors (ICIs) are a class of immunotherapy that have revolutionized the treatment of cancer.
STAMFORD, Conn., Aug. 28, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused...
The FDA accepts Axsome's resubmission of the NDA for AXS-07 for the acute treatment of migraine. A decision is due on Jan. 31, 2025. Shares rise.
KalVista announces FDA acceptance of New Drug Application for sebetralstat for oral on-demand treatment of hereditary angioedema KalVista...