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Results For "approval"

2614 News Found

Biocon to merge Biocon Biologics in $5.5 billion deal
News | December 07, 2025

Biocon to merge Biocon Biologics in $5.5 billion deal

Biocon will acquire the residual stake held by Mylan (Viatris) for a total consideration of US$ 815 million


Merck Animal Health wins FDA’s fast-track green light for first-in-decades cattle parasite treatment
Drug Approval | December 06, 2025

Merck Animal Health wins FDA’s fast-track green light for first-in-decades cattle parasite treatment

The topical fluralaner solution is cleared for the prevention and treatment of new world screwworm infestation


Bristol Myers Squibb secures FDA nod for Breyanzi in marginal zone lymphoma
Drug Approval | December 06, 2025

Bristol Myers Squibb secures FDA nod for Breyanzi in marginal zone lymphoma

The one-time CAR T cell infusion now becomes the first and only therapy of its kind cleared for this patient population


Briefs: IOL Chemicals & Pharmaceuticals, Ipca Laboratories and Anuh Pharma
News | December 06, 2025

Briefs: IOL Chemicals & Pharmaceuticals, Ipca Laboratories and Anuh Pharma

Ipca Laboratories receives three observations from USFDA for API facility at Tarapur


Jacobio combo delivers 71% ORR, sets stage for first SHP-2–based NSCLC therapy
Clinical Trials | December 04, 2025

Jacobio combo delivers 71% ORR, sets stage for first SHP-2–based NSCLC therapy

Jacobio stated that these findings underscore the potential of glecirasib and sitneprotafib


Aelis Farma gets EMA nod for phase 2B trial of AEF0217 in down syndrome
Biopharma | December 04, 2025

Aelis Farma gets EMA nod for phase 2B trial of AEF0217 in down syndrome

AEF0217 is a first-in-class CB1 receptor signaling-specific inhibitor


FDA expands nod of Eli Lilly’s Jaypirca for earlier CLL/SLL treatment
Drug Approval | December 04, 2025

FDA expands nod of Eli Lilly’s Jaypirca for earlier CLL/SLL treatment

Jaypirca is the first and only FDA-approved non-covalent (reversible) BTK inhibitor


Bristol Myers to extend key trial of Cobenfy in Alzheimer’s psychosis
Clinical Trials | December 04, 2025

Bristol Myers to extend key trial of Cobenfy in Alzheimer’s psychosis

The company is excluding data from the affected sites to maintain the study's integrity


Celltrion gets Health Canada nod for Eylea biosimilar Eydenzelt
Clinical Trials | December 03, 2025

Celltrion gets Health Canada nod for Eylea biosimilar Eydenzelt

Health Canada’s approval was based on a comprehensive evaluation of analytical, nonclinical, and clinical data


US District Court grants summary judgement in Favour of SPARC for Sezaby PRV
News | December 03, 2025

US District Court grants summary judgement in Favour of SPARC for Sezaby PRV

FDA's withholding of the PRV was contrary to law because no drug product containing phenobarbital sodium was 'previously approved'