-
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).
-
Rare Disease Therapeutics, Inc. Announces New Expanded FDA Approved Indication for Antivenom ANAVIP® for Treatment of North American Pit Viper Envenomation
americanpharmaceuticalreview
April 07, 2021
Rare Disease Therapeutics, Inc. (RDT) announced that the United States (US) Food & Drug Administration (FDA) approved a new expanded indication for ANAVIP® (crotalidae immune F(ab’)2 (equine)), an equine-derived antivenin, for the management of adult ...
-
Exelixis Announces U.S. FDA Accepts Investigational New Drug Application for XB002 in Patients with Advanced Solid Tumors
americanpharmaceuticalreview
April 07, 2021
Exelixis, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of XB002 in patients with ...