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vTv Therapeutics Receives FDA Breakthrough Therapy Designation for TTP399 for the Treatment of Type 1 Diabetes americanpharmaceuticalreview
April 14, 2021
vTv Therapeutics Inc. a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and psoriasis, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough ...
US approval for first AI device to help detect colon cancer pharmatimes
April 13, 2021
The US Food and Drug Administration (FDA) has authorised a new medical device that uses artificial intelligence (AI) based on machine learning to help clinicians detect potentials signs of colon cancer.
FDA Approves New Dosing Regimen for Cetuximab americanpharmaceuticalreview
April 12, 2021
On April 6, 2021, the Food and Drug Administration approved a new dosage regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks (Q2W) for cetuximab (Erbitux, ImClone LLC) for patients with K-Ras wild-type, EGFR-expressing colorectal ...
AbbVie presents applications to FDA and EMA for approval of SKYRIZI in psoriatic arthritis pharmaceutical-business-review
April 09, 2021
AbbVie has submitted applications seeking approval for SKYRIZI (risankizumab-rzaa, 150 mg) and SKYRIZI (risankizumab, 150 mg) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively, for the treatment of ...
Philippines halts use of AstraZeneca vaccine for people below 60 years pharmaceutical-technology
April 09, 2021
The Philippines Department of Health (DOH) has adopted the Food and Drug Administration’s (FDA) recommendation to temporarily put the use of the AstraZeneca Covid-19 vaccine on hold for individuals aged below 60 years.
Zydus Cadila gets final USFDA nod for Macitentan Tablets and eligibility for 180-day shared exclusivity expresspharma
April 09, 2021
Macitentan is used to manage the symptoms of pulmonary arterial hypertension.
Gilead gets US FDA nod for Trodelvy to treat metastatic triple-negative breast cancer expresspharma
April 09, 2021
Trodelvy significantly reduced the risk of death by 49 per cent compared with single-agent chemotherapy in the Phase 3 ASCENT Study.
Study identifies possible COVID-19 drugs - including several that are FDA-approved worldpharmanews
April 08, 2021
A team led by scientists in the Perelman School of Medicine at the University of Pennsylvania has identified nine potential new COVID-19 treatments, including three that are already approved by the Food and Drug Administration (FDA) for treating other ...
FDA approves add-on therapy for patients with genetic form of severely high cholesterol americanpharmaceuticalreview
April 07, 2021
FDA has approved Praluent (alirocumab) injection for adult patients with homozygous familial hypercholesterolemia (HoFH), a genetic condition that causes severely high cholesterol. Praluent is not intended to be used alone but instead added to other ...
FDA Grants Orphan Drug Designation for Shylicine™ americanpharmaceuticalreview
April 07, 2021
Vanessa Biotech, the Hamden, Conn.-based global biomedical company dedicated to making an impact on healthcare markets, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the drug Shylicine™ (patent pending).

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