Bio Pharma Dive

MAY 7, 2023

Patient advocates and doctors are anticipating an approval this month of a treatment they believe to be a breakthrough for a deadly disease. But it’s not clear how well the therapy really works, putting the FDA in a difficult position.

Gene Therapy 281

Gene Therapy Doctors Doctor Gene 281

Pharmaceutical Technology

MAY 7, 2023

Formosa Pharmaceuticals along with AimMax Therapeutics has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for APP13007, a new formulation to treat inflammation and pain after ocular surgery. APP13007 is an aqueous nanosuspension formulation of the potent corticosteroid, clobetasol propionate (0.05%). The homogeneous nanosuspension looks like a solution that provides improved comfort to the eyes and helps drug penetrate well into ocular tissues.

Trials 130

Trials Drugs Development 130

Medical Xpress

MAY 7, 2023

Should healthy people be screened to help reduce their risk of fragility fractures? A new interactive online Fragility Fracture Decision Aid for shared decision-making can help clinicians and patients visualize their individual risk of fracture and the potential benefits and harms of preventive treatment.

Gerontology 97

Gerontology 97

BioSpace

MAY 7, 2023

Partners Biogen and Sage Therapeutics had sought approval for the therapy in both postpartum depression and major depressive disorder, but the FDA rejected the application for the latter.

FDA Approval 52

FDA Approval 52

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Clinical Supply

Trialfacts

MAY 7, 2023

Contents About the Study Why Participate? Your Rights Who Can Participate? More Study Details About the Research Centre Research Centre: Nutrition Research Australia Location: This trial will be conducted remotely Lead Researcher: Dr Flavia Fayet-Moore, PhD HREC: This study has been reviewed and approved by the Bellberry Human Research Ethics Committee About the Study Looking for a way to improve your gut and immune function, as well as your skin’s health?

Research 52

Research Trials Protein Clinical Trials 52

FDA Law Blog

MAY 7, 2023

By Karla L. Palmer — On May 3, 2023, DEA’s Administrator Anne Milgram issued a very brief and lightly publicized statement announcing that DEA intends to issue a “temporary rule” extending telemedicine flexibilities that existed during the COVID-19 Emergency Declaration, which Declaration is set to expire on May 11, 2023. Most notably for the millions of patients who, for over three years, have depended on telemedicine solutions to receive needed controlled substance medications, the Declaratio

Drugs 52

Drugs 52