Feb. 23, 2026 -- Tessera Therapeutics, the biotechnology company pioneering a new approach in genetic medicine known as Gene Writing™, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track and Orphan Drug designations to TSRA-196, its lead in vivo gene editing program. TSRA-196 is being jointly developed with Regeneron for the treatment of adults with alpha-1 antitrypsin deficiency (AATD) who are homozygous for the PiZ allele (PiZZ). TSRA-196 is designed to pr

Approval expands low-dose MRI contrast options for the youngest patients and reflects a positive benefit–risk profile of VUEWAY® injection from birth through adulthood Feb. 23, 2026 -- Bracco, a global leader in diagnostic imaging, today announced that the U.S. Food and Drug Administration (FDA) has approved the extension of the current VUEWAY® (gadopiclenol) solution for injection, intravenous use, for use in neonates and infants. VUEWAY® injection is a macrocyclic gadolinium-based contrast a

February 23, 2026 -- Vidac Pharma Holdings Plc. announces that the first patient has been successfully enrolled and dosed in its Phase 2b clinical study evaluating VDA-1102 for the treatment of highly proliferative lesions of Actinic Keratosis (AK). The initiation of patient dosing follows completion of applicable regulatory requirements, importation of the investigational medicinal product, and training of the medical team at Centroderm GmbH (Wuppertal, Germany). This milestone marks an import

Following approval by the European Commission (EC), sugemalimab has received a new indication approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for stage III non-small cell lung cancer (NSCLC). This marks the second indication approved for the product in the UK. This approval is based on the GEMSTONE-301 study, a multicenter, randomized, double-blind Phase III trial. Results demonstrated that sugemalimab provided statistically significant improvement in progression-

The FDA approved AstraZeneca's BTK inhibitor Calquence (acalabrutinib) in combination with AbbVie and Roche's BCL-2 inhibitor Venclexta (venetoclax) — also marketed by AbbVie as Venclyxto in the EU — for the first-line treatment of chronic lymphocytic leukaemia (CLL) in adults, establishing the first and only all-oral, fixed-duration combination therapy for previously untreated patients. Also see – Spotlight On: BTK inhibitors move towards fixed-duration combos in CLL. "The…approval expands cho

Feb. 20, 2026 -- Brainstorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced it has entered into a definitive agreement for a strategic private placement of $1 million. The financing was structured to reflect the company's current operational momentum and the underlying value of its NurOwn® platform. Premium Pricing: The common stock was priced at $0.60 per share, representing a significant premium to the $0.

More than 80% of those treated with TREMFYA® were in clinical remission and more than 50% were in endoscopic remission at Week 140 of the QUASAR long-term extension study, showing lasting disease control for patients 78% of patients achieved intestinal healing at both the tissue and visual level (histo-endoscopic mucosal improvement) Feb. 21, 2026 -- Johnson & Johnson (NYSE: JNJ) today announced new long-term data from the QUASAR long-term extension (LTE) study showing that TREMFYA® (guselkumab

Feb. 20, 2026 -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved BYSANTI™ (milsaperidone) tablets, a first line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. BYSANTI™ is a new chemical entity (NCE) that belongs in the class of atypical antipsychotics. In clinical studies BYSANTI™ demonstrated bioequivalence to iloperidone acros

81.8% of patients with bothersome tinnitus treated with Lenire at New York Hearing Doctors reported significant improvement in a real-world clinical setting.1,2 Patients with bothersome tinnitus reported a 23.8 point mean reduction in tinnitus as measured by the Tinnitus Handicap Inventory, which is greater than three times the threshold for clinical significance.1,2 The majority of patients with bothersome tinnitus reported they were no longer severely impacted by their tinnitus following 12-we

Feb. 17, 2026 -- Beactica Therapeutics AB, a Swedish precision medicine company, today announced that it, together with leading glioblastoma researchers at KU Leuven, has been awarded a EUR 2.5 million grant by the European Innovation Council (EIC) to advance a precision immune therapy for glioblastoma, the most common and aggressive brain tumour which currently lacks effective treatment. In the project GLIOBREAK, Beactica and KU Leuven are joining forces to advance BEA-17, Beactica's wholly ow