(UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA approved this indication under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in...
PRM Pharma, LLC announces the nationwide availability of HemiClor® (chlorthalidone) 12.5 mg tablets, the first and only FDA-approved 12.5 mg formulation of chlorthalidone for the treatment of hypertension in adults. This milestone comes as the...
immunotherapies for hematologic and other malignancies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the Company’s lead product candidate, M2T-CD33 (LTI-214), for the treatment of Acute...
for patients who received one or more doses of BKZ across BE HEARD I & II and BE HEARD EXT (total of three years). The FDA approved dose of BIMZELX for adult patients with moderate-to-severe hidradenitis suppurativa is 320mg Q2W to Week 16,...
a leading provider of essential medicines and medical technologies, announced that the U.S. Food and Drug Administration (FDA) designated Conexxence®(1) and Bomyntra®(2) (denosumab-bnht) as interchangeable biosimilars to the reference products,...
Atopic Dermatitis clinical trial in the Kingdom and the Emirate of Dubai. This announcement comes on the heels of the U.S. FDA clearance of the Investigational New Drug (IND) application for a Phase 1b/2a study with lead drug candidate RLS-1496 in...
in patients with hereditary angioedema (HAE). Additionally, ADARx announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ADX-324 for the treatment of patients with HAE. “Despite advances in prophylactic...
has advanced its suite of critical care products through premarket approval by the U.S. Food and Drug Administration (FDA) for ZOLL’s Zenix® monitor/defibrillator. The Zenix device is the culmination of years of user feedback and is ZOLL’s most...
At Karius, she built the clinical and regulatory foundation for an infectious disease sequencing test that achieved FDA Breakthrough Device designation. She has also held leadership roles at Clinical Genomics, Ortho Clinical Diagnostics and...
next-generation therapeutics for complement-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CTx001, the company's lead gene therapy candidate. The...
Niagen products (www.niagenplus.com). Pharmaceutical-grade Niagen IV and injections are compounded and distributed by U.S. FDA-registered 503B outsourcing facilities and are available exclusively at clinics with a prescription. Niagen Bioscience’s...
Novartis announced that Rhapsido® (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment....
and we’re proud to work with Corstasis to bring this innovation into practice.” The U.S. Food and Drug Administration (FDA) recently approved ENBUMYST for the treatment of edema associated with congestive heart failure (CHF), and hepatic and renal...
will be presented at the Heart Failure Society of America (HFSA)’s. In July 2025, the U.S. Food and Drug Administration (FDA) approved a new indication for KERENDIA to treat adult patients with heart failure (HF) with left ventricular ejection...
weeks 1 to 12 (43−54%) and months 4 to 12 (55−63%). The median dose reported at Week 1 was 36% of the target weight-banded FDA approved dose; by Week 10 onwards, the median dose was at least 80% of labeled dose. The results of this 12-month...
announced a collaboration with Hims & Hers™, one of the largest digital health platforms for men, to make KYZATREX®, an FDA-approved oral testosterone replacement therapy for adult men with low or no testosterone levels due to certain medical...
Waldencast plc a global multi-brand beauty and wellness platform, announced that the U.S. Food and Drug Administration (“FDA”) has approved Obagi® saypha® MagIQ™ injectable hyaluronic acid (“HA”) gel, the first product in the Obagi® saypha®...
and Breakthrough Therapy Designations for both first- and second-line or later, the U.S. Food and Drug Administration (FDA) approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more at...
2025, ifinatamab deruxtecan was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy....
the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector (SC-AI), LEQEMBI IQLIK, as a weekly starting...
