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FDA Grants IND Approval for Phase II Clinical Trial Using Stemedica's itMSC Therapy for COVID-19 Patients
prnewswire
September 30, 2020
Stemedica Cell Technologies, Inc. has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) approval for "A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety ...
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FDA Encourages Use of Drug Master Files to Support Cannabis Research
americanpharmaceuticalreview
September 27, 2020
The U.S. Food and Drug Administration (FDA) is alerting those involved in research on drugs containing cannabis and cannabis-derived compounds of the potential benefits of using Drug Master Files (DMFs).
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FDA Takes Actions to Help Lower Prescription Drug Prices
americanpharmaceuticalreview
September 27, 2020
The U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA) took actions to help provide safe, effective, and more affordable drugs to American patients as part of the Safe Importation Action Plan ...
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Perrigo Voluntary Recalls Albuterol Inhaler
americanpharmaceuticalreview
September 27, 2020
The U.S. Food and Drug Administration (FDA) is alerting health care professionals and patients of a voluntary recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma Solutions for Perrigo Pharmaceutical Company ...
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Cipla gets US FDA approval for dimethyl fumarate DR capsules
expresspharma
September 27, 2020
It is indicated for the treatment of relapsing forms of multiple sclerosis.
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Granules gets US FDA nod for OTC naproxen sodium and diphenhydramine hydrochloride tablets
expresspharma
September 27, 2020
They are indicated for relief of occasional sleeplessness associated with minor aches and pains.
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US FDA approves Zydus Cadila’s dimethyl fumarate DR capsules
expresspharma
September 27, 2020
These tablets will be manufactured at the group’s manufacturing facility at the SEZ, Matoda.
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USFDA approves Nucala to treat hypereosinophilic syndrome
expresspharma
September 27, 2020
The approval granted to GlaxoSmithKline is the first approval for HES patients in nearly 14 years.
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Zydus Cadila receives tentative USFDA approval for palbociclib capsules
expresspharma
September 27, 2020
It is an anti-cancer medicine that interferes with the growth and spread of cancer cells in the body.
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FDA grants priority review for Pfizer’s Xalkori in paediatric ALCL
pharmaceutical-technology
September 27, 2020
Pfizer has secured priority review from the US Food and Drug Administration (FDA) for Xalkori (crizotinib) to treat relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) in children.