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RSS FeedPosted by Michael Wonder on 28 Jul 2020
Foresee Pharmaceuticals announces submission of NDA for FDA approval of LMIS 50 mg
27 July 2020 - Foresee Pharmaceuticals announced today that it has submitted to the U.S. FDA a new drug application ...
Posted by Michael Wonder on 28 Jul 2020
Lumos Pharma announces sale of priority review voucher
27 July 2020 - ) -- Lumos Pharma today announced that it has entered into a definitive agreement to sell ...
Posted by Michael Wonder on 28 Jul 2020
Dr. Reddy's Laboratories received approval of Xeglyze (abametapir) 0.74% lotion in the U.S.
27 July 2020 - Dr. Reddy’s Laboratories today announced approval of Xeglyze (abametapir) 0.74% topical lotion, new drug application by the ...
Posted by Michael Wonder on 27 Jul 2020
scPharmaceuticals announces FDA acceptance of Furoscix new drug application resubmission
27 July 2020 - FDA sets PDUFA date of 30 December 2020. ...
Posted by Michael Wonder on 27 Jul 2020
Eton Pharmaceuticals submits new drug application to the FDA for orphan drug dehydrated alcohol injection
27 July 2020 - Since the start of COVID-19, the FDA has recalled more than 75 contaminated hand sanitisers due to ...
Posted by Michael Wonder on 27 Jul 2020
Checkmate Pharmaceuticals granted FDA fast track designation for CMP-001 combined with PD-1 blockade in the treatment of certain types of metastatic or unresectable melanoma
27 July 2020 - Checkmate Pharmaceuticals today announced that the U.S. FDA granted fast track designation to its product candidate, ...
Posted by Michael Wonder on 25 Jul 2020
Breztri Aerosphere approved in the US for the maintenance treatment of COPD
24 July 2020 - Approval based on Phase III ETHOS trial which showed a statistically significant reduction in the rate of ...
Posted by Michael Wonder on 24 Jul 2020
FDA approves first cell-based gene therapy for adult patients with relapsed or refractory mantle cell lymphoma
24 July 2020 - Today, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment ...
Posted by Michael Wonder on 24 Jul 2020
Sarepta Therapeutics receives fast track designation for SRP-9001 micro-dystrophin gene therapy for the treatment of Duchenne muscular dystrophy
24 July 2020 - Sarepta Therapeutics today announced that the U.S. FDA has granted fast track designation to SRP-9001 (AAVrh74.MHCK7.micro-dystrophin). ...
Posted by Michael Wonder on 24 Jul 2020
FDA grants fast track designation for Hanmi LAPS triple agonist
22 July 2020 - Hanmi Pharmaceutical announced on July 16th that its LAPS Triple Agonist (HM15211), an innovative new drug for ...
Posted by Michael Wonder on 24 Jul 2020
MyoKardia announces receipt of breakthrough therapy designation from FDA for mavacamten for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy
23 July 2020 - MyoKardia today announced that the U.S. FDA has granted Breakthrough Therapy Designation to mavacamten, a novel, oral, ...
Posted by Michael Wonder on 23 Jul 2020
FDA proposes new rule on reporting requirements
23 July 2020 - Today, the U.S. FDA published the proposed rule, Annual Summary Reporting Requirements Under the Right to ...
Posted by Michael Wonder on 23 Jul 2020
Potential risks of treatment with unapproved regenerative medicine products
22 July 2020 - Protecting patients is at the core of what we do at the U.S. Food and Drug ...
Posted by Michael Wonder on 23 Jul 2020
ElsaLys Biotech announces submission of biologics license application to FDA for Leukotac (inolimomab) for the treatment of graft versus host disease in adult patients
23 July 2020 - The biologics license application will be reviewed under the FDA’s Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 23 Jul 2020
MC2 Therapeutics announces U.S. Food and Drug Administration approval of Wynzora (calcipotriene 0.005% and betamethasone dipropionate 0.064% cream) for adults with plaque psoriasis
22 July 2020 - MC2 Therapeutics announced today that the U.S. FDA has approved Wynzora (calcipotriene and betamethasone dipropionate, w/w ...