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Results For "approval"

2612 News Found

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


Q2 2026 drug catalysts put Replimune, Arvinas and Boehringer in sharp focus: GlobalData
Biopharma | April 03, 2026

Q2 2026 drug catalysts put Replimune, Arvinas and Boehringer in sharp focus: GlobalData

Key FDA decisions and pivotal late-stage obesity and breast cancer data could reshape competitive positioning


Merck secures landmark EU nod for KEYTRUDA in hard-to-treat ovarian cancer
News | April 03, 2026

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


FDA okays Eli Lilly’s new weight-loss pill, expanding options for millions
News | April 02, 2026

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


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


Biogen bags FDA nod for high dose SPINRAZA in spinal muscular atrophy
Drug Approval | April 02, 2026

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


Lilly to acquire sleep drug biotech firm Centessa in $6.3 billion deal
News | April 01, 2026

Lilly to acquire sleep drug biotech firm Centessa in $6.3 billion deal

The company’s broader OX2R portfolio includes clinical and preclinical assets with potential applications across neurological, neurodegenerative, and neuropsychiatric conditions


Agilent bags FDA nod for key cancer diagnostic
News | March 31, 2026

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


ENHERTU approved in China as first HER2-targeted ADC for early breast cancer
Drug Approval | March 31, 2026

ENHERTU approved in China as first HER2-targeted ADC for early breast cancer

The decision is based on the phase 3 DESTINY-Breast11 trial