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Sol-Gel Technologies Announces FDA Approval of TWYNEO
firstwordpharma
July 28, 2021
Sol-GSol-Gel Technologies approved its first proprietary drug product, TWYNEO (tretinoin/benzoyl peroxide) cream, 0.1%/3%, indicated for the treatment of acne vulgaris in adults and pediatric patients nine years.
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Shingrix Approved for Shingles Prevention in Immunocompromised Adults
americanpharmaceuticalreview
July 27, 2021
GlaxoSmithKline plc announced that the US FDA has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are or who will be at increased risk of shingles due to ...
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Sun Pharma and Cassiopea SpA sign license and supply agreements for Winlevi
expresspharma
July 27, 2021
Sun Pharmaceuticals and Cassiopea SpA have signed licence and supply agreements for Winlevi (clascoterone cream 1%) in the United States (US) and Canada.
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FDA Approves Pediatric Type 2 Diabetes Treatment
americanpharmaceuticalreview
July 26, 2021
The U.S. FDA approved Bydureon and Bydureon BCise (exenatide extended-release) injection to be used in addition to diet and exercise to improve glycemic control (blood sugar levels) in pediatric patients 10 years or older with type 2 diabetes.
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FDA Provides Necessary Guidance For BioVaxys To Begin Preparation Of Ind For Phase I/II Clinical Trials Of CoviDTH
prnasia
July 23, 2021
BioVaxys is pleased to announce that the US Food and Drug Administration has provided its official Written Response to the Company's request for a Pre-IND Type B review of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2.
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FDA Approves Carcinoma Treatment
americanpharmaceuticalreview
July 23, 2021
The FDA approved pembrolizumab (Keytruda - Merck) in combination with lenvatinib (Lenvima, Eisai) for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) ...
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Granules Pharmaceuticals clears US FDA audit
expresspharma
July 23, 2021
The company had undergone the PAI audit by the US Food and Drug Administration (FDA) from 21st June, 2021 to 25th June, 2021.
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Zydus Cadila receives tentative approval from USFDA for Ibrutinib
expresspharma
July 23, 2021
The drug will be manufactured at the group’s formulation manufacturing facility at the Special Economic Zone (SEZ), Ahmedabad.
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FDA Approves Octapharma’s Octagam 10% for Adult Dermatomyositis
drugs
July 23, 2021
FDA has granted approval to Octapharma USA for Octagam® 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin to be indicated for the treatment of adult dermatomyositis, a rare immune-mediated inflammatory disease.
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Muffins Recalled for Possible Listeria Contamination
drugs
July 23, 2021
Possible Listeria contamination has triggered the nationwide recall of more than two dozen muffin products made by Give and Go Prepared Foods, the U.S. Food and Drug Administration said Wednesday.