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 The FDA has approved blinatumomab (Blincyto) for treating adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase. This bispecific T-cell engager (BiTE®) therapy targets CD19 surface antigens on B cells, allowing T cells to recognize and eliminate malignant B cells. The approval was based on the Phase 3 E1910 trial showing improved overall survival with blinatumomab plus chemotherapy compared to chemotherapy alone.

 The FDA has approved roflumilast cream 0.15% (Zorvye) for treating mild to moderate atopic dermatitis (AD) in patients aged 6 years and older. This steroid-free, once-daily topical treatment is a selective, highly potent phosphodiesterase 4 (PDE4) inhibitor designed for long-term disease control. The approval was based on phase 3 studies showing significant improvements in disease clearance, itch reduction, and overall skin condition compared to the vehicle group.

 The FDA has approved a new 6mg single-dose prefilled syringe for faricimab-svoa (Vabysmo), facilitating easier administration for neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). Faricimab-svoa is a VEGF and Ang-2 inhibitor, now available in a ready-to-use format. This approval provides an alternative to the existing single-dose vial and is granted to Genentech.

 The FDA is set to decide on OX124, a high-dose naloxone nasal rescue medication designed to reverse opioid overdoses, with the PDUFA date set for July 15, 2024. Developed by Orexo, OX124 offers rapid absorption, high bioavailability, and enhanced stability, addressing the critical need for potent rescue medications due to the high rate of synthetic opioid overdoses. If approved, OX124's launch is anticipated later in 2024.

 The FDA accepted an NDA for vonoprazan (Voquezna) tablets for treating heartburn associated with Non-Erosive gastroesophageal reflux disease (GERD) in adults, with the PDUFA date set for July 19, 2024. Vonoprazan is a potassium-competitive acid blocker (PCAB) offering an alternative to traditional proton pump inhibitors (PPIs). Non-Erosive GERD, affecting 38 million U.S. adults, is characterized by reflux-related symptoms without esophageal mucosal erosions, impacting quality of life with symptoms like heartburn and chest pain.

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- The FDA has approved donanemab (Kisunla) for early symptomatic Alzheimer's disease, making it the third drug in a new class aimed at slowing cognitive decline in early-stage patients. Eli Lilly will make the drug available within weeks following this approval. Donanemab is an anti-amyloid monoclonal antibody that targets amyloid plaques in the brain, a key feature of Alzheimer's.

- The FDA approval was based on clinical trials showing significant benefits in slowing cognitive decline despite concerns about long-term safety. The advisory committee voted unanimously in favor of the drug, with the FDA granting the approval to Eli Lilly.

- The FDA has approved bedaquiline (Sirturo) for treating multidrug-resistant pulmonary tuberculosis (TB) in adults and children aged five and above. Sirturo initially received accelerated FDA clearance for adults in 2012, with later label expansions for younger patients. Bedaquiline, the first TB drug with a new action mechanism in over 40 years, inhibits mycobacterial ATP synthase, essential for energy production in TB bacteria..

- The FDA is nearing a decision on KarXT, a novel antipsychotic for schizophrenia developed by Karuna Therapeutics. KarXT has shown efficacy in reducing symptom severity in clinical trials, with a favorable side effect profile compared to older antipsychotics. Concerns about insurance coverage exist due to the availability of cheaper generics, but a decision is expected by September 26.

- MDMA-assisted therapy for PTSD, developed by Lykos Therapeutics, has shown significant symptom reduction in clinical trials but faces approval challenges. Despite positive trial results, the FDA advisory panel voted against recommending the drug, citing safety concerns. The FDA's final decision is expected by August 11.

- Seladelpar, under consideration for primary biliary cholangitis (PBC), is a drug Gilead recently acquired through the purchase of CymaBay. If approved by August 14, it would expand Gilead's liver disease portfolio. Clinical trials have shown seladelpar to be effective in reducing the itching associated with PBC.

- TransCon PTH by Ascendis Pharma is a treatment for hypoparathyroidism, designed to replace parathyroid hormone and help patients achieve normal calcium levels. Despite manufacturing concerns delaying the FDA's decision, the drug has already been approved in Europe and the UK. A final FDA decision is expected by August 14.

- Afami-cel, a T-cell receptor therapy for synovial sarcoma developed by Adaptimmune Therapeutics, awaits FDA approval by August 4. The therapy targets the MAGE A4 cancer target and is designed as a single-dose treatment. Clinical trial data supporting the application showed efficacy in treating advanced synovial sarcoma.

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- The FDA has approved ensifentrine (Ohtuvayre) as an inhaled maintenance therapy for adults with COPD. Ohtuvayre is the first new mechanism of action for COPD treatment in over two decades, offering anti-inflammatory and bronchodilatory effects to improve lung function and reduce symptoms without the side effects of inhaled corticosteroids. The approval was based on Phase 3 trials showing significant improvement in lung function and fewer exacerbations, granted to Verona Pharma.

- The FDA has approved thiotepa (Tepylute) for breast and ovarian cancer treatment. This new ready-to-dilute formulation saves preparation time and reduces risks, offering benefits like less-invasive treatment options. Breast cancer affects 1 in 8 women, while ovarian cancer has poorer outcomes due to late detection; the approval emphasizes Tepylute's ease of preparation and was granted to Amneal Pharmaceuticals.

- The FDA has approved epcoritamab-bysp (EPKINLY) for adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of prior therapy. EPKINLY is the first T-cell engaging bispecific antibody for this indication, providing a new option for patients with limited treatment choices. The approval was based on the EPCORE® NHL-1 clinical trial, showing a high overall response rate, granted to AbbVie.

- The FDA has approved sofpironium topical gel (Sofdra) for treating primary axillary hyperhidrosis in adults and children aged 9 and older. Sofdra, an anticholinergic agent, reduces sweat production and significantly improves quality of life. The approval, based on two phase 3 studies showing significant improvement in sweat production, was granted to Botanix Pharmaceuticals, with expected availability in late 2024.

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- The FDA has approved pitolisant (Wakix) for treating excessive daytime sleepiness (EDS) in pediatric patients with narcolepsy. Pitolisant, a first-in-class treatment targeting the histamine system, was previously approved for adults with narcolepsy. The approval, based on a Phase 3 study, was granted to Harmony Biosciences.

- The FDA has approved crovalimab-akkz (PiaSky) for treating paroxysmal nocturnal hemoglobinuria (PNH) in patients aged 13 and older. Crovalimab, a complement C5 inhibitor, provides sustained complement inhibition through low-dose administration. The approval, based on efficacy in maintaining complement inhibition, was granted to Genentech, Inc.

- The FDA has approved efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Vyvgart Hytrulo, previously approved for generalized myasthenia gravis, demonstrated effectiveness in a two-stage study showing significant improvement in patient outcomes. The approval was granted to Argenx.

- The FDA has granted fast track designation to IBI343 for treating advanced pancreatic ductal adenocarcinoma (PDAC) that has relapsed or is refractory to one prior therapy. IBI343 is a monoclonal antibody-drug conjugate targeting CLDN18.2-expressing tumor cells. The designation, based on a phase 1 trial showing a 40% overall response rate, was granted to Innovent Biologics.