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KNOXVILLE, Tenn.--(BUSINESS WIRE)--Enigma Biomedical USA (EB USA) today announced the U.S. Food and Drug Administration (FDA) approval of TAUKLARIFY™ (florquinitau F 18 injection, also previously referred to as MK-6240), a radiodiagnostic agent indicated for positron emission tomography (PET) of the brain in adults with cognitive impairment who are being evaluated for Alzheimer’s disease to identify patients with tau neurofibrillary tangle (NFT) pathology. In 2023, EB USA sold its subsidiary, C...

DALLAS--(BUSINESS WIRE)--Lantern Pharma Reports Second Quarter 2026 Financial Results and Provides Business Update...

PRINCETON, N.J.--(BUSINESS WIRE)--U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS...

SAN DIEGO--(BUSINESS WIRE)--Gossamer Bio, Inc. (Nasdaq: GOSS) (the “Company” or “Gossamer”), 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 second quarter ended June 30, 2026, and provided a business update. “We have worked hard to strengthen Gossamer and...

PARSIPPANY, N.J.--(BUSINESS WIRE)--Zoetis Inc. today announced that Simparica Trio has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies. Larvae of Cochliomyia hominivorax, commonly called New World screwworm (NWS), feed on living tissues, such as open wounds, of animals including livestock, wildlife and pets, and can inflict da...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--FDA clears PhenoNet Inc. to advance PHENOGENE-1A into Phase 3 trials for early Alzheimer’s disease, including APOE4 and non-APOE4 patients....

NEW YORK--(BUSINESS WIRE)--Cadence, the clinical AI company automating the treatment of chronic disease, today announced its HypertensionOS software has been selected by the U.S. Food and Drug Administration as the second participant in the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. HypertensionOS is prescription software as a medical device (“SaMD”) that incorporates AI-assisted functionality to support clinician-supervised medication management fo...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spruce Biosciences, Inc. (Nasdaq: SPRB) a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced that Cure Sanfilippo Foundation and the National MPS Society have agreed to make a combined $5.5 million strategic investment in Spruce. The proceeds will be used to partially fund TA-ERT EAP, helping to broaden patient access to invest...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--A new survey reveals that U.S. biotechnology companies focused on developing treatments for rare and serious diseases overwhelmingly prefer to conduct first-in-human (FIH) clinical trials in the United States. However, historical obstacles posed by the U.S. Food and Drug Administration (FDA) are prompting them to seek development overseas – in Australia, Europe, and China. The survey of 37 U.S. biotechnology executives was conducted by the Biotech Consortium t...

NEW YORK--(BUSINESS WIRE)--Definium Therapeutics, Inc. (Nasdaq: DFTX) ("Definium" or the "Company"), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today announced positive topline results from Voyage, its first Phase 3 study of DT120 (lysergide) Orally Disintegrating Tablet (ODT) 100 µg in adults with generalized anxiety disorder (GAD). The results mark the Company’s se...