Biosimilars

Biocon merges its biosimilar and generics units, appointing 30-year veteran Shreehas Tambe as CEO to forge a new globally-scaled biopharma enterprise.

The FDA has clarified its rules for desiccated thyroid extract (DTE), providing relief for patients and a new path forward for manufacturers like Acella.

Maze Therapeutics posts positive Phase 2 data for its genetic kidney disease drug, but a sharp stock drop reveals investor concerns in a competitive race.

With a history of billion-dollar deals, Mark Altmeyer takes the helm at ReproNovo, aiming to commercialize its promising fertility and women's health pipeline.

With a new CFO who helped steer a multi-billion dollar acquisition, Bambusa Therapeutics signals major growth plans for its innovative antibody platform.

BioCardia's FDA milestone for its Helix catheter could unlock a new era of targeted heart therapies, but financial hurdles and clinical questions remain.

An Alabama firm's key regulatory filing for a critical drug component could accelerate the development of cheaper cancer supportive care biosimilars.

Amid fierce competition, Triangle Insights Group hires a seasoned expert to guide clients through the complex world of drug pricing and market access.

Eledon's tegoprubart gets Orphan Drug status, signaling a new era for liver transplant patients by potentially replacing toxic, decades-old therapies.

Alzheon's pill ALZ-801 shows promise in early AD patients with high genetic risk, offering a potential path that avoids the brain swelling seen in IV drugs.

With strong revenue growth and critical FDA decisions on the horizon, MannKind's leadership prepares to outline its vision for investors in Miami.

FDA approves Glenmark's generic inhaler with 180-day exclusivity, promising lower costs for millions and disrupting a major respiratory drug market.

Avenacy launches its 26th product, a generic Benadryl injection, tackling drug shortages and aiming to improve patient safety with unique packaging.

With a strong cash position and promising drug candidate, Apogee Therapeutics is advancing multiple trials to challenge the I&I market with a new therapy.

As Cipla rolls out its affordable Liraglutide injection, the battle for the multi-billion dollar GLP-1 market intensifies, promising greater access for patients.

The biopharma firm beats 2025 guidance on strong specialty and generic sales, forecasting another year of growth fueled by new product launches.

Sarepta will unveil crucial long-term data for its Duchenne gene therapy and exon-skipping drugs at MDA 2026, a pivotal moment for patients and the company.

Heron Therapeutics posts record growth fueled by ZYNRELEF and APONVIE, issuing strong 2026 guidance and signaling a successful pivot to profitability.

Eton Pharmaceuticals wins landmark FDA approval for DESMODA, a breakthrough liquid drug set to transform care for a rare condition by enabling precise, safe dosing.

Curanex Pharmaceuticals hits a key manufacturing milestone for Phyto-N, a botanical drug with a 30-year history, advancing its quest for FDA approval.