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Fda Approvals

All articles tagged with #fda approvals

health5 days ago•9 min saved

Surge in Pediatric GLP-1 Prescriptions Raises Safety and Cost Concerns

Prescriptions for GLP-1 weight-loss drugs among children under 12 have surged 310 times since 2019, with over 20,000 young patients receiving these medications. While FDA-approved for ages 12 and older, off-label use is common for younger children. Experts warn that long-term safety data is lacking, and nearly 17% of young users developed nutritional deficiencies within a year. Insurance coverage remains inconsistent, and doctors emphasize screening for eating disorders before prescribing.

via KCCI|

#childhood-obesity #fda-approvals #glp-1-medications

health21 days ago•10 min saved

CAR T Cell Therapy Evolves: From Blood Cancer Success to Solid Tumor Challenges

CAR T cell therapy has transformed blood cancer treatment, achieving high survival rates, but faces hurdles in cost, side effects, and expanding to solid tumors. Recent FDA approvals for myeloma and myeloproliferative disorders highlight broader immunotherapy advances, while experts debate next-generation designs and accessibility.

via Gizmodo|

#blood-cancer #car-t-cell-therapy #fda-approvals

health1 month ago•15 min saved

FDA Approves Four Updated COVID Vaccines Targeting XFG Variant for 2026-2027 Season

The FDA has approved four updated COVID-19 vaccines for the 2026-2027 season, all targeting the JN.1-lineage XFG variant. These shots are now available at major pharmacies and are recommended for adults 65 and older, as well as younger individuals with underlying health conditions or those who are pregnant. While the CDC has not issued new guidance due to the dissolution of the Advisory Committee on Immunization Practices, major medical associations have issued recommendations mirroring previous protocols. Experts advise getting the vaccine in September or October to ensure protection before the winter surge, noting that the shots are safe and covered by most insurance plans.

via HuffPost|

#covid-19-vaccines #fda-approvals #health

business3 months ago•2 min saved

Kalshi tests pharma milestones with prediction markets on trials and approvals

Kalshi will start offering prediction-market bets on clinical trial outcomes and FDA regulatory decisions, selecting an initial set of markets with partner AppliedXL, signaling a move to apply market-based forecasting to biopharma and potentially provide new data-driven insights while aiming to manage risks in the field.

via STAT|

#appliedxl #business #clinical-trials

health3 months ago•106 min saved

Gene Therapy Breakthrough Brings Hope to Black Americans Living With Sickle Cell

A Louisiana man became the state’s first functionally cured sickle cell patient via 2023 FDA-approved gene therapies Casgevy and Lyfgenia; while these treatments hold promise for tens of thousands who are Black or African American, their high cost (around $2–$3 million) and limited treatment centers create access barriers, highlighting the need for broader insurance coverage, expanded care in underserved communities, and thorough discussion of risks like infertility and long‑term cancer risk.

via MS NOW|

#black-health #fda-approvals #gene-therapy

science6 months ago•11 min saved

Alzheimer’s under scrutiny: the amyloid hypothesis hits a turning point

The piece chronicles how the once-dominant amyloid-β hypothesis has been undermined by multiple retractions and high-profile drug failures, fueling debate over data integrity and regulatory controversy. While FDA-approved antibodies targeting amyloid-β have had limited or questionable benefits and come with serious risks, researchers are increasingly exploring alternatives—such as neuroinflammation, infections, the gut microbiome, and APOE4-related pathways—suggesting Alzheimer's may result from multiple interacting factors rather than a single cause. The article highlights the persistence of amyloid research despite misconduct findings and casts doubt on a simple cure tied to amyloid-β clearance.

via Ars Technica|

#alzheimers-disease #amyloid-b #amyloid-mafia

health7 months ago•3 min saved

FDA Adopts One-Pivotal-Trial Path for Drug Approvals

The FDA will default to approving drugs based on a single well-controlled pivotal trial, while allowing supporting confirmatory evidence such as mechanistic data, related indications, animal models, or real-world data. The move, framed by FDA leaders as a shift from an outdated ‘two-trial dogma,’ aims to speed development and cut costs, but has drawn criticism from some policymakers and former FDA officials who warn it could weaken patient protections. The policy preserves discretion to require additional studies in certain cases, and reactions are mixed among analysts and industry figures, with Pazdur expressing concerns before his retirement.

via BioSpace|

#clinical-trials #confirmatory-evidence #fda-approvals

healthcare9 months ago•20 min saved

2025 FDA Approvals and Their Impact on Biopharma and Ophthalmology

In 2025, the FDA approved 46 new therapeutic agents, including a diverse range of modalities such as biologics, kinase inhibitors, and gene therapies, with cancer remaining the most common therapeutic area. The year was marked by policy changes, staffing challenges, and the launch of new approval pathways, reflecting a tumultuous but innovative period for drug development.

via Nature|

#2025 #biologics #cancer

health-and-medicine2 years ago•19 min saved

"FDA's 2023 Surge in Drug Approvals Marks a Record Year for Pharmaceuticals"

The FDA approved 55 new drugs in 2023, marking a significant increase from the previous year and setting a 10-year rolling average high. Oncology led with 24% of the approvals, followed by neurology. Notable approvals included the first CRISPR–Cas9-based gene editing product, two RSV vaccines, and a burst of gene therapies. AstraZeneca's capivasertib became the first AKT inhibitor approved for breast cancer, and several first-in-class cancer therapies were greenlit. In neurology, Biogen and Ionis's tofersen received accelerated approval for SOD1-mutated ALS, and Eisai and Biogen's lecanemab was approved for Alzheimer's disease. The approvals spanned various modalities, including nucleotide-based therapeutics and T-cell engaging bispecific antibodies.

via Nature.com|

#biologics #drug-development #fda-approvals