Newsroom | 14402 results
Sorted by: Latest
-
U.S. FDA Grants Priority Review to Supplemental New Drug Application for HYRNUO® (sevabertinib) Under Investigation as a First-Line Treatment of HER2-Mutated Non-Small Cell Lung Cancer
WHIPPANY, N.J.--(BUSINESS WIRE)--U.S. FDA Grants Priority Review to sNDA for HYRNUO® (sevabertinib) Under Investigation as a First-Line Treatment of HER2-Mutated NSCLC...
-
Turn Therapeutics Appoints Physician-Scientist and Former FDA Commissioner, Dr. Stephen M. Hahn, as Executive Clinical and Regulatory Lead
WESTLAKE VILLAGE, Calif.--(BUSINESS WIRE)--Turn Therapeutics Inc. (Nasdaq: TTRX), a clinical-stage biotechnology company developing targeted, localized therapies for inflammatory skin diseases, today announced the appointment of Stephen M. Hahn, M.D., former Commissioner of the U.S. Food and Drug Administration (FDA), to oversee the clinical and regulatory strategy for GX-03, the Company’s investigational topical therapy currently in a Phase 2 clinical trial for moderate-to-severe atopic dermat...
-
CEL-SCI Reports Fiscal Second Quarter 2026 Results
VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI reported financial results for three months ended March 31, 2026, as well as key corporate developments for Multikine....
-
Endospan Announces Closing of Acquisition by Artivion, Inc., Following FDA PMA Approval of the NEXUS® Aortic Arch System
HERZLIYA, Israel--(BUSINESS WIRE)--Endospan, a pioneer in endovascular solutions for complex aortic pathologies, today announced that Artivion, Inc. (NYSE: AORT) has closed the transaction to acquire the company. This strategic milestone follows the April 2026 U.S. Food and Drug Administration (FDA) PMA approval of the NEXUS® Aortic Arch System, the first off-the-shelf endovascular solution designed to treat aortic arch disease, including chronic aortic dissections, in patients at high risk for...
-
Gossamer Bio, Inc. Launches Exchange Offer and Consent Solicitation Intended to Eliminate Over $120 Million of Debt with Existing Noteholder Support
SAN DIEGO--(BUSINESS WIRE)--Gossamer Bio, Inc. (NASDAQ: GOSS) (the “Company”), a biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), today announced that it has commenced an exchange offer (the “Exchange Offer”) to exchange any and all of its 5.00% Convertible Senior Notes due 2027 (the “Existing Convertible Notes”) for a...
-
Target RWE and NoviSci Rebrand as Pedestal Health and Headwater Science
DURHAM, N.C.--(BUSINESS WIRE)--Target RWE and NoviSci, two leaders in evidence generation, today announced they will rebrand as Pedestal Health and Headwater Science. These two distinct companies will work to build a modern evidence-generation engine for life sciences organizations, navigating the most complex and consequential research challenges. Pedestal Health (formerly Target RWE) is a full-service evidence generation partner for life sciences organizations. The company delivers scientific...
-
BAXFENDY approved in the US as the first and only aldosterone synthase inhibitor treatment for adults with hypertension
WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca’s BAXFENDY™ (baxdrostat) has been approved in the US as a first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled. There are 1.4 billion people worldwide living with hypertension.1 In the US, approximately 50% of patients living with hypertension who are already taking multiple antihypertensive me...
-
Gossamer Bio Announces First Quarter 2026 Financial Results and Provides Business Update
SAN DIEGO--(BUSINESS WIRE)--Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), today announced its financial results for the first quarter ended March 31, 2026, and provided a business update. Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a...
-
United Therapeutics Corporation Announces ADVANCE OUTCOMES Study of Ralinepag Presented at ATS 2026
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that full results of its ADVANCE OUTCOMES study are being presented today during the Breaking News: 2026 Clinical Trial Results in Pulmonary Medicine session at the annual meeting of the American Thoracic Society (ATS) International Conference in Orlando. Ralinepag has not been approved for use in any indication by the U.S. Food and Dr...
-
ImmunityBio Signs Exclusive U.S. Agreement with Japan BCG Laboratory for the Tokyo Strain of BCG to Enhance BCG Supply in the United States
WASHINGTON--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced an exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory ("JBL"), the Tokyo-based developer and manufacturer of the Tokyo strain of BCG (Tokyo-172 BCG). The agreement provides ImmunityBio exclusive U.S. rights to develop, import, and commercialize intravesical Tokyo-172 BCG. JBL's Tokyo strain of BCG is supported by the February 2026 positive Phase III rea...