Pfizer Inc. is investing $500 million to expand a manufacturing facility in Sanford, North Carolina, that plays a central role in the company’s efforts to become a major player in gene therapy.
Four months after securing $125 million in funding, SpringWorks Therapeutics is eying another $115 million from a potential initial public offering.
An unnamed Novartis executive sold 925,400 Swiss francs ($946,000) worth of shares less than three weeks before the U.S. Food and Drug Administration announced data from tests of the company’s gene therapy Zolgensma had been manipulated.
The FDA proposed new health warnings for cigarette packages and ads due to small size and lack of an image in current warnings.
A look at potential new developments important to health communications and marketing.
The U.S. FDA issued a new draft guidance for drugmakers aiming their resources at Fabry disease, a rare genetic disease.
Shares of Texas-based Lexicon Pharmaceuticals shot up after the company announced positive 52-week cardiorenal data from a pooled analysis of the type 1 diabetes trials Tandem1 and Tandem2.
U.S. FDA Expands Regulatory Approvals for LEO Pharma’s Enstilar Foam and Taclonex Topical Suspension in Treatment of Plaque Psoriasis
LEO Pharma Inc announced the U.S. Food and Drug Administration expanded the approved indication for Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis to include patients age 12 and older. Additionally, the FDA approved Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension in the topical treatment of scalp and body plaque psoriasis in patients 12 years and older.
Eton Pharmaceuticals Inc. announced that Aucta Pharmaceuticals Inc.’s New Drug Application for ET-105, an innovative formulation of lamotrigine which Eton acquired the U.S. marketing rights to in June 2019, was accepted for review by the U.S. Food and Drug Administration.