GlaxoSmithKline has achieved a significant regulatory milestone as China's National Medical Products Administration granted priority review status to linerixibat, an investigational treatment for cholestatic pruritus associated with primary biliary cholangitis.…
Two of Intellia Therapeutics’ clinical trials that had been on hold since October 2025 have now been released by the FDA. According to The New England Journal of Medicine, the…
REGENXBIO encountered a significant regulatory obstacle when the FDA issued a complete response letter regarding its biologics license application for RGX-121, an investigational gene therapy targeting mucopolysaccharidosis II (MPS II),…
Tardive dyskinesia represents one of medicine's cruelest ironies: a side effect born from the very medications designed to restore psychiatric health. For generations, treating this involuntary movement disorder meant accepting…
Vanda Pharmaceuticals has achieved a significant regulatory milestone with the FDA's approval of milsaperidone (Bysanti), a newly designated atypical antipsychotic medication poised to help adults battling schizophrenia and acute bipolar…
The landscape of advanced breast cancer treatment is shifting. Genentech's filing acceptance of giredestrant, an experimental oral medication, represents a pivotal moment for thousands of women grappling with a particularly…
AbbVie has announced a landmark regulatory milestone with the US FDA's approval of a supplemental new drug application (sNDA) for the combination of Venclexta (venetoclax) and acalabrutinib as a first-line…
The relationship between people with type 1 diabetes and their medication has always been complicated. For decades, managing the condition has required constant vigilance including mentally calculating food intake, predicting…
Patients using Zepbound for weight management now have a simpler option for administering their medication. As reported by PharmaLive.com, Eli Lilly received FDA clearance for a redesigned injection pen that…
On this episode of Wait, How Do You Spell That?, host Bree Clare sits down with Dr. Charles Link, a pioneering oncologist whose career has fundamentally shaped modern cancer medicine…
Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for Priority Review the Biologics License Application (BLA) for garetosmab, marking a significant milestone for patients living with…
Eli Lilly is making strategic moves to expand its obesity medication Zepbound beyond weight management, demonstrating promising results when combined with its autoimmune therapeutic Taltz for treating patients with both…
A Chinese biopharmaceutical company has cleared a major regulatory milestone with a groundbreaking approach to cancer immunotherapy. As reported by PharmaBiz.com, the FDA has authorized CStone Pharmaceuticals to begin phase…
AstraZeneca is navigating the final regulatory hurdles for an alternative delivery method of its lupus therapy. As reported by PharmaBiz.com, the company received a complete response letter from the FDA…
When ovarian cancer returns and becomes resistant to platinum-based treatments, patients face one of oncology's most difficult scenarios. As reported by Drugs.com, a new therapeutic approach is changing this reality.…
Cabaletta Bio has announced significant progress in its development of chimeric autoantibody receptor T cell (CAAR-T) therapies, marking a major milestone with the initiation of its first pivotal myositis trial…
Elevar Therapeutics has achieved a significant regulatory milestone with the US Food and Drug Administration's acceptance of a resubmitted New Drug Application for rivoceranib in combination with camrelizumab as first-line…
When patients and families face a life-or-death disease, bureaucracy often feels like the enemy. Yet in early February 2026, the FDA delivered something rare: a formal response letter that transcended…
Primary biliary cholangitis (PBC) represents a chronic, progressive autoimmune liver disease characterized by the destruction of small bile ducts, leading to cholestasis and potentially fatal complications. Affecting millions globally with…
Otsuka has launched an ambitious awareness initiative designed to fundamentally shift how healthcare professionals understand and approach attention-deficit/hyperactivity disorder (ADHD). As reported by FiercePharma.com, the company's "All of ADHD" campaign…
Takeda Pharmaceutical has reached a significant milestone in the development of oveporexton (TAK-861), with the US Food and Drug Administration officially accepting and granting Priority Review status to the investigational…
Twelve‑month, real‑world data from a large U.S. registry suggest that faricimab provides effective, durable, and safe treatment for retinal vein occlusion (RVO), reinforcing findings from earlier clinical trials and its…
A first-of-its-kind Phase 3b study has shown that combining Eli Lilly’s Taltz (ixekizumab) with Zepbound (tirzepatide) delivers superior benefits for adults living with both active psoriatic arthritis (PsA) and obesity…
A new study in Nature Communications and reported by Scienmag.com overturns a central assumption in eye biology by showing that key stem cells for the retina’s blood vessels are not…
A trio of Swiss biotechnology companies is advancing diverse therapeutic pipelines, with recent developments spanning inflammatory skin disease, immune‑mediated hair loss, and hard‑to‑treat cancers. Together, these milestones highlight how distinct…
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