Stockhead on MSN1d
Biocurious: FDA approval remains the Holy Grail for ASX life science stocks
Despite the Trump administration's shake-up of the agency, the US FDA is the first port of call for most ASX biotechs.
Medscape13d
As Trump Administration Probes Long-Approved Medications, Could FDA Revoke Approvals?
A new federal commission will ‘investigate’ decades-old mental health as well as weight loss drugs, prompting concerns from ...
Managed Healthcare Executive7d
FDA Approves First Generics of Xarelto
Two companies have received approved for a generic of the 2.5 mg tablet of anticoagulant rivaroxaban, which is used to reduce ...
Managed Healthcare Executive9d
FDA Approves First Biosimilar of Xolair
Celltrion’s Omlyclo is interchangeable with Xolair to treat the same conditions: asthma, chronic rhinosinusitis, food allergy ...
FDA approves Xeris Biopharma’s sNDA of Gvoke VialDx as gastro diagnostic aid
Holdings announced that its supplemental new drug application, sNDA, of Gvoke VialDx has received U.S Food and Drug ...
ANI Pharmaceuticals Announces FDA Approval for Expansion of ILUVIEN® Label
ILUVIEN now approved for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in addition to ...
US FDA issues labeling changes for testosterone products
The U.S. Food and Drug Administration said on Friday it issued new labeling changes for testosterone products based on ...
San Diego biotech gets FDA approval for EpiPen alternative for kids
Parents and pediatricians just gained one more tool to combat severe allergic reactions in young kids. San Diego-based ARS ...
MPR23d
FDA Approves Merilog, a Rapid-Acting Insulin Biosimilar Product
Insulin-aspart-szjj is the first rapid-acting insulin biosimilar approved and the third insulin product approved by the FDA.
Medical Dialogues14h
FDA Approves Needle-Free Allergy Treatment for Kids
The US Food and Drug Administration (FDA) has approved Neffy, a nasal spray for treating severe allergic reactions in children aged 4 and above. This is the first emergency allergy treatment ...
California biotech company gets FDA approval for EpiPen alternative for kids
Parents and pediatricians just gained one more tool to combat severe allergic reactions in young kids. San Diego-based ARS ...
Benzinga.com29d
FDA Approves Sanofi's Merilog As First Rapid-Acting Insulin Biosimilar Product For Diabetes
Merilog, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA. Join Nic Chahine live on Wednesday, March 19, at 6 PM ET for a step-by-step ...