logo

FDA/Panel Decisions

Share

covidtest sep28 The U.S. Food and Drug Administration said it now intends to review only a small subset of new emergency use authorization or EUA requests for diagnostic tests. As per an updated COVID-19 test policy with a view to ensure continued access to tests, the regulator further urged developers of all test types seeking marketing authorization to pursue traditional premarket review for most test types.

Citius Pharmaceuticals, Inc. (CTXR) has submitted a Biologics License Application to the FDA for denileukin diftitox, an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma. I/ONTAK is a purified and more bioactive formulation...

Biopharmaceutical company CRISPR Therapeutics (CRSP) announced Wednesday that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to CTX130, the Company's wholly-owned allogeneic CAR T cell therapy targeting CD70, for the treatment of Mycosis...

UroGen Pharma Ltd. (URGN) announced the FDA has authorized an extension of the in-use period for JELMYTO for pyelocalyceal solution admixture from 8 hours to 96 hours following reconstitution of the product. The company noted that the extension has implications for all stakeholders including physicians,...

Dutch biopharmaceutical company Pharming Group N.V. (PHAR) announced that the US Food and Drug Administration has accepted for priority review its New Drug Application or NDA for leniolisib to treat the rare primary immunodeficiency activated phosphoinositide 3-kinase delta syndrome or APDS in adults...

Avidity Biosciences, Inc. (RNA) announced the FDA has placed a partial clinical hold on new participant enrollment in the phase 1/2 MARINA clinical trial of AOC 1001 in adults with myotonic dystrophy type 1. The partial clinical hold is in response to a serious adverse event reported in a single participant...

Pulse Biosciences, Inc. (PLSE), a bioelectric medicine company, has received FDA clearance for its CellFX System to expand the indication for use in the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III.

Biopharmaceutical company Atea Pharmaceuticals, Inc. (AVIR) announced Monday that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to AT-752, a novel, orally administered, direct-acting antiviral for the treatment of dengue virus infection. AT-752, a novel, orally administered...

Bausch Health Companies Inc. (BHC, BHC.TO) and Glenmark Specialty S.A., a subsidiary of Glenmark Pharmaceuticals Ltd., announced Friday that RYALTRIS (olopatadine hydrochloride and mometasone furoate nasal spray) has been approved by Health Canada for the symptomatic treatment of moderate to severe seasonal...

British drug major AstraZeneca Plc (AZN.L, AZN) Wednesday said its Tezspire (tezepelumab) has been approved in the European Union for the treatment of severe asthma. Tezspire is approved as an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled...

BridgeBio Pharma, Inc. (BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and oncology, along with Sentynl Therapeutics, Inc., got marketing authorization from the European Commission for NULIBRY, injectable treatment of patients with Molybdenum Cofactor Deficiency Type A.

Medical technology company Stryker Corp. (SYK) announced Tuesday that its OptaBlate bone tumor ablation system (OptaBlate) received 510(k) clearance from the U.S. Food and Drug Administration. Stryker's first bone tumor ablation system with patented microinfusion technology offers a reliable solution...

RNAi therapeutics company Alnylam Pharmaceuticals, Inc. (ALNY) announced Tuesday that the European Commission has granted marketing authorization for AMVUTTRA (vutrisiran), an RNAi therapeutic for the treatment of hereditary transthyretin-mediated or hATTR amyloidosis in adult patients with stage 1 or...

Medical technology firm Zimmer Biomet Holdings, Inc. (ZBH) announced Tuesday the U.S. Food and Drug Administration (FDA) 510(k) clearance of the Identity Shoulder System for anatomic, reverse and revision shoulder replacement. The Identity Shoulder System is a convertible system that uses proprietary...

Swiss drug major Roche (RHHBY) announced Monday that the European Commission approved Vabysmo (faricimab) to treat neovascular or 'wet' age-related macular degeneration or nAMD and visual impairment due to diabetic macular edema or DME. These retinal conditions are among the major causes of vision...

Follow RTT