Actinium Pharmaceuticals Initiates Novel Triplet Therapy Trial for Frontline AML Treatment
Actinium Pharmaceuticals has launched a first-of-its-kind clinical trial evaluating Actimab-A in combination with venetoclax and ASTX-727 for newly diagnosed acute myeloid leukemia patients unsuitable for intensive chemotherapy.
Hikma Pharmaceuticals Prepares to Launch Generic Versions of Ozempic and Wegovy
Hikma Pharmaceuticals is in talks with global partners to develop generic versions of semaglutide, the active ingredient in Novo Nordisk's blockbuster weight loss drugs Ozempic and Wegovy.
Ketamir-2 Demonstrates Superior Efficacy in Chemotherapy-Induced Neuropathic Pain Model
MIRA Pharmaceuticals' Ketamir-2 shows 60% greater efficacy than gabapentin in reducing chemotherapy-induced neuropathic pain in preclinical studies.
MIRA Pharmaceuticals' Ketamir-2 Demonstrates Superior Efficacy Over Gabapentin in Chemotherapy-Induced Neuropathic Pain Model
MIRA Pharmaceuticals' Ketamir-2 showed 60% greater efficacy than gabapentin, an FDA-approved drug, in reducing chemotherapy-induced neuropathic pain in preclinical studies.
Vertex Pharmaceuticals Faces Mixed Outlook for Suzetrigine After Phase 2 Data
Vertex Pharmaceuticals' Suzetrigine showed less promising Phase 2 results for lumbosacral radiculopathy, reducing the probability of success from 50% to 15%.
Ketamir-2 Demonstrates Superior Efficacy Over Gabapentin in Chemotherapy-Induced Neuropathic Pain
MIRA Pharmaceuticals' Ketamir-2 shows 60% greater efficacy than gabapentin in reducing chemotherapy-induced neuropathic pain in preclinical studies.
Syndax Pharmaceuticals' Revuforj Receives FDA Approval for Acute Leukemia with KMT2A Translocation
Syndax Pharmaceuticals' Revuforj (revumenib) has gained FDA approval for treating acute leukemia in adult and pediatric patients with KMT2A translocation.
Gildeuretinol Receives FDA Fast Track and Rare Pediatric Disease Designations for Stargardt Disease
Gildeuretinol (ALK-001) receives FDA Rare Pediatric Disease and Fast Track designations for Stargardt disease, a progressive condition causing severe vision loss.
Thetis Pharmaceuticals Secures $9M Funding to Advance Novel Oral IBD Treatment
Essex-based Thetis Pharmaceuticals has received $9 million from the Helmsley Charitable Trust to advance TP-317, an innovative oral therapy for inflammatory bowel disease.
Foresee's Linvemastat Shows Promising Safety Profile in Phase 1 Trial
Foresee Pharmaceuticals' linvemastat (FP-020), a novel oral MMP-12 inhibitor, demonstrates a favorable safety and tolerability profile in a Phase 1 clinical trial.
Rege Nephro Acquires Tamibarotene Assets from Syros Pharmaceuticals for ADPKD Development
Kyoto-based Rege Nephro has acquired Tamibarotene-related clinical and non-clinical assets from Syros Pharmaceuticals to advance its ADPKD treatment program.
Sonoma Pharmaceuticals' Hypochlorous Acid-Based Acne Products Gain UK Regulatory Approval
Sonoma Pharmaceuticals has secured MHRA registration for its hypochlorous acid-based acne products, which will be distributed through 1,200+ stores of a leading UK pharmacy chain.
Dupixent Approved for COPD: A New Era in Targeted Therapy
The FDA has approved Dupixent (dupilumab) for COPD, marking the first targeted therapy addressing the IL-4 and IL-13 pathways linked to type 2 inflammation.
BDR Pharmaceuticals Plans $100 Million U.S. Expansion to Boost Global Footprint
BDR Pharmaceuticals is in advanced talks to acquire $100 million worth of manufacturing assets in the United States, with a decision expected within 3-4 months.
Gildeuretinol Receives FDA Fast Track and Rare Pediatric Disease Designations for Stargardt Disease
Gildeuretinol (ALK-001) received Rare Pediatric Disease and Fast Track designations from the FDA for treating Stargardt disease, a progressive condition causing vision loss.
Mycovia Pharmaceuticals Initiates Phase 2 Trial of Oteseconazole for Cryptococcal Meningitis
Mycovia Pharmaceuticals has enrolled the first participant in the PLATFORM-CM Phase 2 trial evaluating oteseconazole for cryptococcal meningitis treatment.
Newron Pharmaceuticals Advances Pivotal Phase III Program for Treatment-Resistant Schizophrenia
Newron Pharmaceuticals has received regulatory approval for its ENIGMA-TRS Phase III program evaluating Evenamide as an add-on therapy for treatment-resistant schizophrenia, with patient recruitment beginning immediately.
Enanta Pharmaceuticals Gains Buy Ratings Amid RSV Drug Development Progress
Enanta Pharmaceuticals receives reiterated Buy ratings from JMP Securities and Robert W. Baird, citing promising RSV drug trial results and reduced competition.
ANI Pharmaceuticals Launches Generic Estradiol Gel, 0.06% Following FDA Approval
ANI Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA) for Estradiol Gel, 0.06%, a generic version of EstroGel.
Acadia Pharmaceuticals Eyes Billion-Dollar Sales Milestone and Global Expansion
Acadia Pharmaceuticals anticipates exceeding $1 billion in net sales in 2025, driven by strong performance from NUPLAZID and DAYBUE.