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FDA accepts Hepion’s IND application for CRV431 to treat Covid-19 pharmaceutical-business-review
December 28, 2020
The US Food and Drug Administration (FDA) has accepted Hepion Pharmaceuticals’ investigational new drug (IND) application for its CRV431, a novel cyclophilin inhibitor, to treat Covid-19.
Lupin gets tentative approval from USFDA for Efinaconazole Topical Solution expresspharma
December 28, 2020
It is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
USFDA defers action on BLA for Avastin biosimilar, notifies Biocon Biologics, Mylan expresspharma
December 28, 2020
To complete the application, the agency noted that an inspection of the manufacturing facility is required as a part of the standard review process.
Foresee Pharmaceuticals Announces Completion of US$47 Million Financing prnasia
December 25, 2020
Foresee pharmaceuticals announces that it has successfully completed an underwritten public offering of 15,000,000 shares of its common stock to the public at a price of NT$88 per share.
Moderna’s Covid-19 vaccine obtains Health Canada authorisation pharmaceutical-technology
December 25, 2020
Moderna has received authorisation for its Covid-19 vaccine from Health Canada for the immunisation of individuals aged 18 years and above.
Caplin Steriles gets US FDA approval for Etomidate injection expresspharma
December 25, 2020
Caplin Steriles, a subsidiary company of Caplin Point Laboratories has been granted final approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) Etomidate injection USP, 20 mg/10 ml ...
Ridgeback Biotherapeutics’ Ebola treatment scores FDA approval pharmatimes
December 24, 2020
Ridgeback Biotherapeutics’ Ebanga has been approved by the US Food and Drug Administration (FDA) for the treatment of Ebola in adult and paediatric patients.
FDA Authorizes COVID-19, Flu Combination Test with Home-Collected Samples americanpharmaceuticalreview
December 24, 2020
The U.S. Food and Drug Administration (FDA) authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu).
Hepcidin Mimetic Candidate Receives Fast Track Designation for Polycythemia Vera americanpharmaceuticalreview
December 23, 2020
Protagonist Therapeutics announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PTG-300 in the treatment of polycythemia vera, a rare disease characterized by the excessive production of red blood cells. PTG-300 is ...
FDA Approves First Adjuvant Therapy for Most Common Type of Lung Cancer americanpharmaceuticalreview
December 23, 2020
The U.S. Food and Drug Administration (FDA) approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation.

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