ImmunityBio responds to FDA concerns over promotional content

Alembic Pharma wins USFDA nod for generic Dapagliflozin, secures 180-day exclusivity

Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.

FDA okays Eli Lilly’s new weight-loss pill, expanding options for millions

The approval is backed by results from Lilly’s ATTAIN clinical trial program, which showed significant weight loss among participants

Biogen bags FDA nod for high dose SPINRAZA in spinal muscular atrophy

The new regimen, delivering 50 mg/5 mL and 28 mg/5 mL doses, offers a higher concentration of the drug for both loading and maintenance phases

FDA nod to Johnson & Johnson’s oral psoriasis therapy 'ICOTYDE'

New targeted pill offers hope for adults and teens with moderate-to-severe plaque psoriasis

Lilly expands access to Zepbound weight-loss drug with $299 monthly self-pay option

The expanded program allows patients to fill prescriptions either at a local pharmacy or through home delivery via LillyDirect

FDA nod to Bristol Myers Squibb’s Sotyktu as new oral therapy for psoriatic arthritis

The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials

Roche’s Gazyva shows breakthrough results in Lupus phase III trial

Gazyva/Gazyvaro outperformed placebo across all key and secondary endpoints

Granules India’s US packaging facility clears FDA inspection with zero observations

The inspection concluded with zero observations, confirming the facility's compliance with current Good Manufacturing Practices

Zydus hits Keytruda biosimilar milestone with successful FYB206 trial, targets USFDA filing

Zydus has in-licensed FYB206, a proposed biosimilar to immuno-oncology therapy Keytruda (pembrolizumab), exclusively from Formycon AG for the U.S. and Canadian markets