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Results For "FDA-approval"

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EssilorLuxottica receives FDA authorization for its Essilor Stellest lens for myopia control
Medical Device | April 28, 2026

EssilorLuxottica receives FDA authorization for its Essilor Stellest lens for myopia control

The company plans a phased expansion across India, focusing initially on metro cities and early-adoption hubs


Essilor Stellest lens positioned as key breakthrough in myopia control in India
News | April 28, 2026

Essilor Stellest lens positioned as key breakthrough in myopia control in India

The lens received U.S. Food and Drug Administration (FDA) market authorization via the De Novo pathway in late 2025


AstraZeneca wins US nod for at-home lupus treatment in major shift for SLE care
News | April 28, 2026

AstraZeneca wins US nod for at-home lupus treatment in major shift for SLE care

The approval was driven by data from the Phase III TULIP-SC trial


Pharma firms accelerate regional GLP-1 capacity to de-risk supply chains amid geopolitical tensions: GlobalData
News | April 14, 2026

Pharma firms accelerate regional GLP-1 capacity to de-risk supply chains amid geopolitical tensions: GlobalData

At the centre of this shift is Eli Lilly and Company, whose latest investments in China and Japan are helping redefine the next phase of GLP-1 supply strategy


Eli Lilly launches once-daily weight-loss pill Foundayo
News | April 12, 2026

Eli Lilly launches once-daily weight-loss pill Foundayo

The once-daily oral medication is approved for adults with obesity or overweight who have weight-related medical conditions


Apnimed secures $150 million financing to fuel US launch of oral sleep apnea drug AD109
News | April 08, 2026

Apnimed secures $150 million financing to fuel US launch of oral sleep apnea drug AD109

The financing includes a four-year interest-only period, extendable to five years if a net sales milestone is achieved


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


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