-
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.
-
RedHill Biopharma's Second COVID-19 Candidate Cleared by FDA for Phase 2/3 Study
americanpharmaceuticalreview
November 26, 2020
RedHill Biopharma announced the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for a Phase 2/3 study evaluating orally administered RHB-107 (upamostat) in patients with symptomatic COVID-19 ...
-
PLx Pharma Submits sNDAs for VAZALORE
americanpharmaceuticalreview
November 26, 2020
PLx Pharma announced two chemistry and manufacturing control (CMC) supplemental New Drug Applications (sNDAs), one for VAZALORE 325 mg and one for VAZALORE 81 mg dose (referred to together as VAZALORE), have been submitted to the U.S. Food and Drug ...