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Apr 28, 2026
AbbVie filed an sBLA for SKYRIZI as a subcutaneous induction therapy for Crohn's disease, supported by Phase 3 AFFIRM data. SKYRIZI and Rinvoq combined for $25.9B in 2025 revenue, exceeding 2027 guidance. The FDA also approved Venclexta plus acalabrutinib in CLL.
Apr 20, 2026
Kyverna Therapeutics reports positive long-term follow-up results for its CAR-T therapy miv-cel in generalized myasthenia gravis, with plans to submit a biologics license application in the first half of 2026. The company has $279.3 million in cash providing runway into 2028 to fund launch and Phase 3 trials.
Apr 19, 2026
AbbVie said Skyrizi and Rinvoq generated $26.0 billion in 2025 sales and are expected to exceed $31 billion in 2026. The company said the two immunology drugs continue to offset Humira erosion and drive top-line growth.
Apr 17, 2026
The Middle East and Africa biosimilars market is estimated to grow from USD 1.15 billion to USD 5.73 billion by 2035 at a 19% CAGR. Monoclonal antibodies hold almost 55% of market share, while oncological disorders dominate demand.
Apr 11, 2026
A FAERS database analysis identified 13 FDA-approved systemic medications with disproportionately high uveitis reporting signals among 7,301 events from 2003 to 2024. The strongest signals were for cidofovir and rifabutin, and the findings were described as hypothesis-generating rather than causal.
Apr 09, 2026
Dr. Reddy's said the FDA accepted for review its 351(k) BLA for DRL_AB, a proposed interchangeable biosimilar to ORENCIA. The application covers an IV formulation for RA, PsA and pJIA.
Mar 24, 2026
The FDA has eased biosimilar approval procedures as these therapies have generated $56 billion in savings since 2015. New guidance eliminates comparative efficacy studies, potentially saving manufacturers $100 million per product and cutting development time by 50%. Despite growth to 23% of the biologics market, a "biosimilar void" threatens $232 billion in missed savings over the next decade.
Mar 23, 2026
Bio-Thera Solutions expands its partnership with Intas Pharmaceuticals for BAT2506, a golimumab biosimilar, through an exclusive commercialization agreement for India. The India biosimilars market is projected to grow from $184 million to $1.02 billion by 2035, driven by patent expirations and strategic partnerships.
Mar 18, 2026
Diacerein, an anthraquinone derivative, shows promise as a disease-modifying agent in rheumatoid arthritis through its anti-inflammatory and chondroprotective actions, with combination therapy appearing to enhance therapeutic benefits.
Mar 10, 2026
Researchers unveil tumor-intrinsic role of PD-L1 in lung cancer progression and develop systematic method for discovering molecular glues that selectively degrade disease proteins, while advances in immunology research aim to improve care for immune-mediated inflammatory diseases.
Mar 05, 2026
The global biosimilar market is experiencing robust growth, valued at USD 36.79 billion in 2024 and projected to reach USD 282.3 billion by 2035 at a CAGR of 20.35%, driven by patent expirations, cost pressures, and expanding access to biologic therapies.
Feb 28, 2026
Insmed reported total revenues of $606.4 million for 2025, with ARIKAYCE growing 19% annually. The FDA granted orphan drug designation to treprostinil palmitil for pulmonary arterial hypertension treatment in January 2026.
Feb 21, 2026
The FDA has accepted Dr. Reddy's Laboratories' BLA for DRL_AB, a proposed interchangeable biosimilar to abatacept, submitted in December 2025. The application is the first for an abatacept biosimilar and is supported by Phase 1 data showing pharmacokinetic similarity.
Feb 23, 2026
The FDA has accepted for review Beren Therapeutics' NDA for adrabetadex in infantile-onset Niemann-Pick disease type C with a PDUFA date of August 17, 2026, and Dr. Reddy's BLA for a biosimilar to Orencia (abatacept).
Feb 21, 2026
The US FDA has accepted Dr Reddy's Biologics License Application for DRL-AB, a proposed interchangeable biosimilar to Orencia (abatacept) for intravenous infusion, marking the first abatacept biosimilar submission.
Feb 21, 2026
Dr. Reddy's Laboratories has received FDA acceptance for its biosimilar application targeting Bristol-Myers Squibb's Orencia, marking the first U.S. application for an off-patent version of the arthritis treatment that generated $2.7 billion in 2025.
Feb 19, 2026
Scientists at Northwell Health's Feinstein Institutes have developed a novel drug discovery strategy transforming a detrimental immune element into a therapeutic for sepsis and rheumatoid arthritis, published in Military Medical Research.
Feb 16, 2026
The global biopharmaceutical industry entered 2026 facing one of the largest waves of patent expirations in its history, with $200-300 billion in yearly sales at risk through 2032 as major drugs lose exclusivity.
Feb 14, 2026
Eli Lilly achieved positive outcomes for nearly all R&D key events in 2025 and acquired Orna Therapeutics for $2.4 billion to develop circular RNA therapies for autoimmune diseases.
Feb 14, 2026
Eli Lilly acquired Orna Therapeutics for $2.4 billion and announced multiple partnerships while investing in AI drug discovery infrastructure, including building the industry's largest AI supercomputer to boost clinical trial success rates.
