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.

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

Merck secures landmark EU nod for KEYTRUDA in hard-to-treat ovarian cancer

Its a major breakthrough for women’s ovarian cancer care in Europe

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

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

Bavarian Nordic seeks EMA nod for Mpox vaccine in children aged 2–11

The trial demonstrated that immune responses in children were non-inferior to adults, with a similar safety profile after two standard doses of MVA-BN

Agilent bags FDA nod for key cancer diagnostic

The FDA approval makes PD-L1 IHC 22C3 pharmDx the only companion diagnostic approved to detect tumors expressing PD-L1 in esophageal or GEJ carcinoma patients for KEYTRUDA treatmen

GSK seeks European nod for promising Hepatitis B therapy

Teva hits major biosimilar milestones with FDA nod and regulatory filings

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

Wockhardt’s breakthrough antibiotic Zaynich wins key regulatory nod in India