FDA approval

Axogen has priced an upsized public offering of common stock, aiming to raise approximately $124 million in gross proceeds. The company intends to use these funds to pay off its term loan facility, bolster working capital, and support future growth initiatives. This move follows recent strong revenue reports and FDA approval for its AVANCE product, positioning Axogen for continued expansion in the peripheral nerve repair market.

Omeros Corporation has rescheduled its conference call to January 7, 2026, at 4:30 p.m. ET to discuss the FDA approval and upcoming U.S. launch of YARTEMLEA® on January 2, 2026. YARTEMLEA® is the first and only treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The call will provide details on this significant milestone.

Novo Nordisk’s FDA approval for the first oral obesity pill marks a significant shift, democratizing weight management beyond injections. This move, priced affordably, boosts Novo Nordisk shares and intensifies competition with Eli Lilly. The article also covers Dominion Energy’s offshore wind project halt, Skydance Media’s bid for Warner Bros. Discovery, Alphabet’s data center acquisition, and the EV sector’s recalibration amidst slower-than-expected demand. Instacart is ending controversial AI pricing tests due to consumer concerns, and US gasoline prices have hit four-year lows.

The FDA has approved Lunsumio VELO™, a subcutaneous formulation, for relapsed or refractory follicular lymphoma patients who have failed two or more prior therapies. This novel treatment offers a significantly reduced administration time, transforming from a hours-long infusion to a one-minute injection. This advancement aims to decrease patient burden and increase treatment flexibility, with a fixed-duration schedule potentially as short as six months. The approval is based on promising efficacy data, including a high objective response rate and a manageable safety profile, with ongoing research exploring its use in earlier lines of therapy.

GSK’s *Exdensur* (depemokimab-ulaa) has received FDA approval for severe eosinophilic asthma in adults and adolescents. This groundbreaking biologic offers an ultra-long-acting, twice-yearly dosing regimen, a first in its class, significantly reducing asthma exacerbations based on SWIFT-1 and SWIFT-2 trials. It addresses a critical unmet need, potentially transforming patient care with improved adherence and reduced healthcare burden.

SeaStar Medical raised $4M through a registered direct offering of 5.24 million shares priced at $0.763 each, with five-year warrants exercisable at $0.638. The capital infusion supports commercialization of its FDA-approved pediatric AKI device and adult trials, but triggers 33% equity dilution. Analysts note the structure creates potential stock price pressure, as warrants priced 16% below offering prices might constrain valuations. While addressing immediate liquidity needs, the conventional equity approach suggests urgency in funding operations rather than strategic growth initiatives, with funds allocated vaguely for corporate purposes.

Enanta Pharmaceuticals (ENTA) announced FDA approval for MAVYRET (glecaprevir/pibrentasvir), now the only eight-week oral treatment for acute HCV in adults and children (3+ years). The approval allows providers to immediately treat diagnosed HCV patients with a 96% cure rate. This breakthrough aims to prevent chronic disease progression and supports the global public health goal of HCV elimination by 2030.