Company Product Description Indication Status
Amneal Pharmaceuticals Inc., of Bridgewater Township, N.J. Lidocaine Patch, 5% Generic Lidoderm patch, 5% Post-herpetic neuralgia The FDA approved its ANDA
Capricor Therapeutics Inc., of Los Angeles CAP-1002 Allogeneic cardiac cell therapy COVID-19 The FDA accepted its IND application for a phase II clinical trial
EMD Serono, part of Merck KGaA, of Darmstadt, Germany Tepotinib  MET inhibitor Metastatic non-small-cell lung cancer with MET exon 14 skipping alterations The FDA accepted the NDA and granted priority review 
Gyroscope Therapeutics Ltd., of London Orbit Subretinal Delivery System Microinjection procedure designed to avoid damaging the structure of the eye by preventing the need for a vitrectomy or retinotomy Subretinal microinjection of balanced salt solution or BSS Plus at the back of the eye The FDA granted 510(k) clearance 
Imara Inc., of Boston IMR-687 Small-molecule inhibitor of PDE9 Sickle cell disease The European Commission granted orphan drug designation
Knight Therapeutics Inc., of Montreal, and Therapeuticsmd Inc., of Boca Raton, Fla. Imvexxy  Estradiol vaginal inserts Postmenopausal moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy Health Canada approved it
Metacrine Inc., of San Diego MET-409 Farnesoid X receptor agonist Nonalcoholic steatohepatitis The FDA granted fast track designation
Regenxbio Inc., of Rockville, Md. RGX-314 NAV AAV8 vector encoding an antibody fragment targeting VEGF Diabetic retinopathy using suprachoroidal delivery The FDA cleared the IND for a phase II trial 
Sarepta Therapeutics Inc., of Cambridge, Mass. Casimersen Binds to exon 45 of dystrophin pre-mRNA Duchenne muscular dystrophy amenable to skipping exon 45 The FDA accepted the NDA


For more information about individual companies and/or products, see Cortellis.

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