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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.
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.
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) ...
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.
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.
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.
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.
FDA Expands Indication for PROGRAF® for Lung Transplant Recipients americanpharmaceuticalreview
July 22, 2021
Astellas Pharma Inc. announced that the U.S. FDA approved its supplemental New Drug Application (sNDA) for PROGRAF® (tacrolimus) for the prevention of organ rejection in adult and pediatric lung transplant recipients.
FDA Approves Drug for Severe Itching in Patients Liver Disease americanpharmaceuticalreview
July 22, 2021
FDA has approved Bylvay (odevixibat), the first treatment for pruritus (moderate to severe itching) in patients aged three months and older with progressive familial intrahepatic cholestasis (PFIC), a rare progressive liver disease that typically ...
Former FDA adviser calls for wider probe into Biogen Alzheimer’s drug approval expresspharma
July 22, 2021
A federal probe of the US Food and Drug Administration’s approval of a controversial new Alzheimer’s disease drug should look into why that decision was made without clear evidence of patient benefit, a former adviser to the agency said 20th.

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