The FDA has expanded the indication for baricitinib (Olumiant), a once-daily oral JAK inhibitor, to include adolescents aged 12 and older with severe alopecia areata. This marks the second JAK inhibitor treatment approved for adolescents with the condition.
The FDA has approved Roche's obinutuzumab (Gazyva), an anti-CD20 agent, for treating idiopathic nephrotic syndrome in patients as young as 2 years old. This marks the first new drug approval for this kidney condition in seven decades.
The FDA has approved Juvmo (tavapadon), the first and only dopamine agonist designed to selectively target D1/D5 receptors for treating adults with Parkinson's disease. The once-daily oral tablet can be taken with or without levodopa therapy and came from AbbVie's $8.7 billion acquisition of Cerevel Therapeutics.
The FDA has approved Mirum Pharmaceuticals' Atebrioz (zilurgisertib), a once-daily pill for fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic disorder that causes soft tissue to turn to bone. This marks the third FDA-approved treatment for FOP, following recent approvals of Regeneron's Pasatru and Ipsen's Sohonos.
The U.S. Food and Drug Administration has approved Eli Lilly's Onswik, a once-weekly basal insulin injection for adults with type 2 diabetes. The approval offers patients an alternative to daily long-acting insulin injections, potentially reducing the number of injections by more than 300 per year.
Kyverna Therapeutics released one-year follow-up data showing patients with stiff person syndrome remained off other therapies after treatment with its CAR-T cell therapy miv-cel. The company plans to file for FDA priority review this year, which would make it the first cell therapy approved for an autoimmune disease.
The FDA has approved Lyrfigtu (lirafugratinib) as a second-line treatment for cholangiocarcinoma (bile duct cancer) with FGFR2 fusion or other rearrangements. The drug demonstrated a 46% confirmed objective response rate and median duration of response of 11.8 months in clinical trials.
The U.S. FDA has approved AQNEURSA (levacetylleucine) as the first and only approved treatment for ataxia-telangiectasia (A-T) in the United States or anywhere in the world. This marks the second FDA-approved indication for AQNEURSA.
The FDA granted full approval to Ultragenyx's gene therapy Fayuvi for Sanfilippo syndrome type A, marking the first-ever approved treatment for the ultra-rare, fatal neurodegenerative disease. The approval comes after a previous regulatory rejection and represents a significant milestone for patients with this devastating condition.
The FDA has approved Curium's Bexlutry (lutetium Lu 177 dotatate injection), marking the industry's first radioligand equivalent and setting up the first generic competition for Novartis in the radioligand therapy field. The approval came after a court cleared Curium of all patent claims.
The US Food and Drug Administration has granted expanded accelerated approval for sevabertinib as a frontline treatment option for patients with HER2-mutant advanced non-small cell lung cancer, with nursing management focusing on diarrhea monitoring.
The FDA granted accelerated approval to AstraZeneca's oral SERD camizestrant (Etcamah) for breast cancer treatment, marking a rare divergence from its expert advisory panel's recommendation and opening a new ctDNA-guided treatment paradigm.
The FDA granted accelerated approval to AstraZeneca's oral SERD camizestrant (Etcamah) in combination with CDK4/6 inhibitors for ESR1-mutated breast cancer, overriding a negative advisory committee recommendation.
The FDA approved Zanvastro, an antisense oligonucleotide therapy from Ionis Pharmaceuticals, as the first targeted treatment for Alexander disease, a rare and deadly genetic neurological disorder affecting adults and children. The company priced the injectable drug at $285,000 per dose.
Revolution Medicines' breakthrough pill targeting KRAS mutations in advanced pancreatic cancer received FDA approval, priced at over $475,000 per year. The drug nearly doubles survival in patients with this hard-to-treat cancer.
The FDA has approved TAUKLARIFY (florquinitau F 18 injection), a novel diagnostic imaging agent developed by Enigma Biomedical USA to identify tau neurofibrillary tangles in patients being evaluated for Alzheimer's disease, including tangles isolated to the medial temporal lobe.
The FDA has approved Zenbexus (iberdomide) for multiple myeloma treatment, marking the first approval in the novel CELMoD drug class that uses targeted protein degradation. Bristol Myers Squibb acquired the therapy through its Celgene acquisition and is positioning it as a successor to its legacy myeloma products.
Scientists report progress in malaria vaccine development with new antibody-targeting approaches, while separate research reveals increasingly sophisticated drug resistance in malaria parasites. Meanwhile, FDA approval of Moderna's mRNA flu vaccine strengthens the case for applying mRNA technology to malaria and other diseases.
Scientists report progress in malaria vaccine development with new antibody-targeting approaches, while separate research reveals increasingly sophisticated drug resistance in malaria parasites. Meanwhile, FDA approval of Moderna's mRNA flu vaccine strengthens the case for applying mRNA technology to malaria and other diseases.
The Food and Drug Administration approved Moderna's mFlusiva on Wednesday, marking the first mRNA-based influenza vaccine authorized in the U.S. The vaccine is approved for adults aged 50 and older, representing a significant expansion of mRNA technology beyond COVID-19 vaccines.
The U.S. Food and Drug Administration has approved LYTENAVA (bevacizumab-vikg) for treating neovascular age-related macular degeneration (wet AMD), marking the first FDA-approved ophthalmic formulation of bevacizumab after 20 years of off-label use. The approval comes on Outlook Therapeutics' fourth regulatory attempt, though the company faces cash constraints as it enters commercialization.
The U.S. Food and Drug Administration approved a nonprescription fixed-dose combination pill containing acetaminophen (650 mg) and naproxen sodium (220 mg), marketed as Tylenol with Naproxen by Kenvue. The medication provides up to 12 hours of pain relief for patients aged 12 and older.
The FDA has approved Sanofi's Sarclisa (isatuximab) for subcutaneous delivery via a wearable on-body injector, marking the first cancer drug to receive approval for this delivery method. The device offers multiple myeloma patients a less burdensome alternative to intravenous infusions.
The U.S. Food and Drug Administration has granted accelerated approval to Vera Therapeutics' drug TRUTAKNA for treating adult patients with primary IgA nephropathy, a potentially life-threatening chronic autoimmune kidney disease. The approval sent Vera's shares up 6.8% in afternoon trading.
The FDA has approved Vertex Pharmaceuticals' Casgevy (exagamglogene autotemcel) for patients aged two years and older with sickle cell disease and transfusion-dependent beta thalassemia, expanding from the previous minimum age of 12 years. The approval was granted under the agency's Commissioner's National Priority Voucher program.
The U.S. FDA has approved Orca Bio's TREGZI, the first precision-engineered cell therapy for allogeneic transplants in adults with hematological malignancies, designed to reduce stem cell transplant complications.
The U.S. Food and Drug Administration has approved Viridian Therapeutics' Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease, marking the first FDA-approved treatment for the condition and setting up direct competition with Amgen's blockbuster drug Tepezza.
The FDA approved sacituzumab govitecan-hziy (Trodelvy) on June 24, 2026, for two indications in adults with triple-negative breast cancer: as monotherapy and in combination with pembrolizumab (Keytruda) for first-line treatment of advanced disease, offering new options beyond standard chemotherapy.
The FDA has approved the combination of belzutifan (Welireg) and pembrolizumab (Keytruda) as adjuvant treatment for patients with clear cell renal cell carcinoma at high risk of recurrence following nephrectomy, based on data from the phase 3 LITESPARK-022 trial.
The U.S. Food and Drug Administration on Tuesday approved bemotrizinol as a permitted active ingredient for over-the-counter sunscreens, marking the first new UV filter cleared since the late 1990s. The broad-spectrum ingredient has been widely used in Europe and Asia for years.
Cytokinetics announced its heart disease drug Myqorzo, already approved in one indication, succeeded in meeting twin efficacy goals in a Phase 3 trial for genetic heart disease, potentially boosting future sales.
The FDA approved Ranluspec as the first interchangeable ranibizumab biosimilar, Biocon launched denosumab biosimilars Bosaya and Aukelso in the US, and Celltrion's Truxima became the first Korean biosimilar to lead its segment in US prescriptions.
