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Rigel Finalizes Study Design of Fostamatinib Trial for Warm Autoimmune Hemolytic Anemia americanpharmaceuticalreview
December 01, 2020
Rigel Pharmaceuticals has reached agreement with the U.S. Food and Drug Administration (FDA) on the final design of its FORWARD study, a pivotal Phase 3 clinical trial of fostamatinib disodium hexahydrate (fostamatinib) in warm autoimmune hemolytic ...
Moderna announces vaccine efficacy of 94.1 per cent, to file for EUA with US FDA expresspharma
December 01, 2020
Primary efficacy analysis of the Phase 3 COVE study of mRNA-1273 involving 30,000 participants included 196 cases of COVID-19, of which 30 cases were severe.
FDA defers approval of DaxibotulinumtoxinA for Injection in glabellar lines due to Covid-19 related travel restrictions pharmaceutical-business-review
November 30, 2020
Revance Therapeutics announced that the United States (U.S.) Food and Drug Administration (FDA) has deferred a decision on the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection, an investigational neuromodulator product for the ...
Unichem gets US FDA approval for Atenolol and Chlorthalidone Tablets expresspharma
November 30, 2020
They are indicated for the treatment of hypertension, to lower blood pressure.
FDA approval of Provention Bio’s Teplizumab could bring first disease-modifying therapy to type 1 diabetes space expresspharma
November 27, 2020
If Provention Bio’s rolling Biologic License Application (BLA) submission to the FDA for teplizumab is approved, teplizumab will be the first disease-modifying therapy for type 1 diabetes (T1D).
Altimmune submits FDA application for intranasal Covid-19 vaccine candidate pharmaceutical-technology
November 27, 2020
Altimmune has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) to start a Phase I clinical study of its Covid-19 vaccine candidate.
Senhwa Announces Multiple IND Application Submissions to US FDA and Health Canada for the Treatment of Solid Tumors with BRCA2 or PALB2 Mutations prnasia
November 26, 2020
Senhwa Biosciences, Inc., a clinical-stage biopharmaceutical company focused on next-generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, announced that it has submitted multiple Investigational New Drug (IND) applications to ...
FDA approves first treatment for rare paediatric genetic diseases europeanpharmaceuticalreview
November 26, 2020
Zokinvy (lonafarnib) capsules have been approved for the treatment of Hutchinson-Gilford progeria syndrome and certain progeroid laminopathies in patients over one year old.
US pharma initiates litigation challenging HHS and FDA action europeanpharmaceuticalreview
November 26, 2020
PhRMA and other organisations have challenged action by the HHS and FDA that permits the importation of drugs from Canada without drug manufacturers’ oversight.
FDA Authorizes COVID-19 Test for Self-Testing at Home americanpharmaceuticalreview
November 26, 2020
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and provides rapid results.

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