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CARE Receives May Proceed Letter from FDA for COVID-19 Trial americanpharmaceuticalreview
November 17, 2020
Senhwa Biosciences announced its clinical partner, Center for Advanced Research and Education (CARE) in Gainesville, Georgia, has received a Study May Proceed letter from the US Food and Drug Administration (FDA) to begin a phase II ...
FDA approves Merck’s Keytruda with chemotherapy to treat breast cancer pharmaceutical-technology
November 17, 2020
Merck (MSD) has secured approval from the US Food and Drug Administration (FDA) for its Keytruda in combination with chemotherapy for treating patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumours ..
Dr Reddy’s launches Succinylcholine Chloride Injection in US expresspharma
November 16, 2020
It is a sterile, nonpyrogenic solution to be used as an ultra-short acting, depolarizing, skeletal muscle relaxant.
NATCO gets US FDA approval for Pomalidomide capsules expresspharma
November 16, 2020
Natco Pharma announced that its marketing partner, Breckenridge Pharmaceutical, has received final approval for its Abbreviated New Drug Application (ANDA) for Pomalidomide Capsules, from the US Food and Drug Administration {USFDA).
Israel to enter into a deal with Pfizer for COVID-19 vaccine expresspharma
November 16, 2020
The supply would begin in January 2021, with the remainder arriving throughout the course of 2021: Israel’s Health Minister.
FDA grants emergency use authorisation to COVID-19 antibody bamlanivimab europeanpharmaceuticalreview
November 13, 2020
The neutralising antibody therapy bamlanivimab (LY-CoV555) is authorised for emergency use in recently diagnosed patients who are at risk of developing severe COVID-19.
FDA grants Fast Track Designation to Novavax COVID-19 vaccine candidate europeanpharmaceuticalreview
November 13, 2020
The FDA has given Fast Track Designation to NVX-CoV2373, Novavax’s COVID-19 vaccine candidate, created using recombinant nanoparticle technology.
Amneal gets US FDA approval for Acyclovir Cream expresspharma
November 13, 2020
It is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.
Lupin’s alliance partner Concord gets USFDA nod for Tacrolimus Capsules expresspharma
November 13, 2020
They are indicated for prophylaxis of organ rejection in adult and paediatric patients receiving allogeneic liver, kidney or heart transplants.
Sedor Pharmaceuticals gets FDA approval for SESQUIENT to treat status epilepticus pharmaceutical-business-review
November 12, 2020
Sedor Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved SESQUIENT (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients.

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