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US FDA issues warning letter to Shilpa Medicare for Jadcherla facility, Telangana expresspharma
October 12, 2020
The company believes that the warning letter will have minimum impact of disruption of supplies and the existing revenues from operations of this facility.
Foresee Pharmaceuticals Announces NDA for CAMCEVI(TM) 42MG Accepted for Review by the FDA prnasia
October 10, 2020
Foresee Pharmaceuticals Co., Ltd. announced that the 505(b)(2) New Drug Application (NDA) for FP-001 LMIS 50mg, or CAMCEVI™ 42MG, a ready-to-use 6-month depot formulation of leuprolide mesylate, has been accepted for review by the U.S. Food and Drug ...
ImmunoGen gets FDA breakthrough therapy status for IMGN632 to treat relapsed or refractory BPDCN pharmaceutical-business-review
October 10, 2020
ImmunoGen has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its IMGN632 to treat patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN).
FDA grants GlycoMimetics rare paediatric disease designation for rivipansel for treatment of sickle cell disease pharmaceutical-business-review
October 10, 2020
GlycoMimetics announced that the U.S. Food and Drug Administration (FDA) has granted the Company a Rare Pediatric Disease designation for rivipansel for the treatment of sickle cell disease in patients 18 years old and younger.
FDA broadly supports Oragenics’ Pre-IND development programme for SARS-CoV-2 vaccine pharmaceutical-business-review
October 10, 2020
Oragenics, Inc. announced receipt of feedback to its Type B Pre-IND Meeting Request from the U.S. Food and Drug Administration (“FDA”) that it is in broad agreement with the Company’s planned approach to clinical development of its SARS-CoV-2 vaccine ...
ARCA gets FDA approval of IND for Covid-19 drug candidate AB201 pharmaceutical-business-review
October 10, 2020
ARCA biopharma said that its investigational new drug (IND) application for AB201 (rNAPc2) as a potential treatment for patients hospitalised with Covid-19 has been approved by the US Food and Drug Administration (FDA).
US FDA awards six clinical trials research grants to develop medical products for rare diseases expresspharma
October 10, 2020
FDA received 47 clinical trial grant applications that were reviewed and evaluated for scientific and technical merit by more than 90 rare disease and clinical trial experts.
Givinostat from Italfarmaco gets FDA rare pediatric disease designation in duchenne muscular dystrophy expresspharma
October 10, 2020
The Italfarmaco Group provided an update on the development of Givinostat, its proprietary histone deacetylase (HDAC) inhibitor, in boys with Duchenne Muscular Dystrophy (DMD).
INOVIO COVID-19 vaccine trials on partial hold after additional queries from US FDA expresspharma
October 10, 2020
Working to address the FDA's questions and plans to respond in October, informed the company.
Eton Pharma gets US FDA approval for orphan drug ALKINDI SPRINKLE (hydrocortisone) expresspharma
October 10, 2020
It is indicated as replacement therapy in paediatric patients with adrenocortical insufficiency.

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