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CiRC Biosciences Announces Orphan Drug Designation for Retinitis Pigmentosa americanpharmaceuticalreview
March 17, 2021
CiRC Biosciences announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for chemically induced photoreceptor-like cells (CiPCs) for the treatment of retinitis pigmentosa (RP).
Cytocom Gets FDA Clearance for Phase II Trial of COVID Immune Therapy contractpharma
March 17, 2021
Phase 2 clinical trial to evaluate the safety and efficacy of CYTO-205 as a treatment to slow or halt the progression of SARS-CoV-2.
USFDA grants priority review to Merck’s NDA for HIF-2α inhibitor Belzutifan pharmaceutical-business-review
March 17, 2021
The US Food and Drug Administration (FDA) has granted priority review for Merck’s New Drug Application (NDA) for the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor belzutifan.
Strides gets USFDA approval for Potassium Chloride for Oral Solution expresspharma
March 16, 2021
Potassium Chloride Oral Solution is indicated for the treatment and prophylaxis of hypokalemia.
Sun Pharma, Dr Reddy’s, Aurobindo, Jubilant recall products in US expresspharma
March 15, 2021
The Indian firms have initiated recall of these products for various reasons including failed impurities/degradation specifications, failed dissolution specifications, presence of foreign tablets, illegible label etc.
FDA Authorizes Cue Health's COVID-19 Test for At-Home, OTC Use americanpharmaceuticalreview
March 12, 2021
Cue Health has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over-the-counter (OTC) sale of its fast, accurate, COVID-19 test, making it the nation's first molecular diagnostic test available to ...
Roche Receives FDA approval for VENTANA ALK CDx Assay with LORBRENA americanpharmaceuticalreview
March 12, 2021
Roche announced US Food and Drug Administration (FDA) approval of the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with Pfizer's drug LORBRENA® ...
TissueTech Receives FDA Clearance for TTAX03 Study to Treat Facet Joint Osteoarthritis Pain americanpharmaceuticalreview
March 12, 2021
Amniox Medical announced its parent company TissueTech had received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a dosing study using its Investigational New Drug (IND) TTAX03 to treat facet joint pain resulting from OA.
CapsCanada Launches Liquid-Filled Hard Capsule Mfg. Service in North America contractpharma
March 11, 2021
CapsCanada, a Lyfe Group company and provider of capsule technology, has launched a new liquid-filled hard capsule manufacturing service.
Roche to withdraw US indication for Tecentriq in bladder cancer pharmaceutical-technolog
March 10, 2021
Roche is set to voluntarily withdraw the US indication for Tecentriq (atezolizumab) in prior platinum treated metastatic urothelial carcinoma (mUC, bladder cancer) following its consultation with the US Food and Drug Administration (FDA).

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