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Results For "US-FDA"

423 News Found

Sun Pharma flags mixed Fibromun trial results, advances new Phase III study in soft tissue sarcoma
Biotech | April 04, 2026

Sun Pharma flags mixed Fibromun trial results, advances new Phase III study in soft tissue sarcoma

The company has highlighted setbacks in Phase II studies while outlining fresh regulatory and late-stage development plans for Fibromun and Nidlegy


Cipla strengthens US respiratory portfolio with final FDA nod for generic Nintedanib
Drug Approval | April 04, 2026

Cipla strengthens US respiratory portfolio with final FDA nod for generic Nintedanib

ANDA approval for 100 mg and 150 mg capsules targeting idiopathic pulmonary fibrosis opens access to a $3.76 billion market in USA


Saharsh Davuluri takes over as CEO & MD of Neuland  Laboratories
Appointment | April 02, 2026

Saharsh Davuluri takes over as CEO & MD of Neuland Laboratories

18-year veteran Saharsh will position the CDMO as a premier global API process development and commercial manufacturing specialist


Teva hits major biosimilar milestones with FDA nod and regulatory filings
Drug Approval | March 31, 2026

Teva hits major biosimilar milestones with FDA nod and regulatory filings

The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia


Biocytogen partner NEOK Bio gets FDA nod for novel cancer therapy
Biotech | March 31, 2026

Biocytogen partner NEOK Bio gets FDA nod for novel cancer therapy

The investigational new drug application with FDA was actually for NEOK002, an EGFR/MUC1-targeting antibody-drug conjugate aimed at solid tumors


Novo Nordisk India sets patient-centred price of Rs. 202/day for starting dose of Ozempic and Wegovy
News | March 31, 2026

Novo Nordisk India sets patient-centred price of Rs. 202/day for starting dose of Ozempic and Wegovy

Price of the starting dose of Ozempic and Wegovy reduced by 36% and 48% respectively


ImmunityBio scores first Asian approval for ANKTIVA in Macau
News | March 25, 2026

ImmunityBio scores first Asian approval for ANKTIVA in Macau

The Macau authorization followed a regulatory review that considered prior decisions by both the US FDA) and the European Medicines Agency


Siemens Healthineers expands radiotherapy beyond cancer, targets osteoarthritis pain
News | March 25, 2026

Siemens Healthineers expands radiotherapy beyond cancer, targets osteoarthritis pain

The radiotherapy systems include TrueBeam, TrueBeam STx, VitalBeam, and Edge


Sun Pharma scores FDA review for ILUMYA in psoriatic arthritis
News | March 18, 2026

Sun Pharma scores FDA review for ILUMYA in psoriatic arthritis

ILUMYA has already earned FDA approvals for scalp and nail plaque psoriasis in April 2024 and December 2025