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Results For "FDA"

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Neurocrine Biosciences to acquire Soleno Therapeutics for $2.9 billion
News | April 08, 2026

Neurocrine Biosciences to acquire Soleno Therapeutics for $2.9 billion

The acquisition adds VYKAT XR (diazoxide choline), the first FDA-approved therapy for hyperphagia in Prader-Willi syndrome (PWS), a rare genetic disorder, to Neurocrine’s portfolio


Biocon launches denosumab biosimilars Bosaya and Aukelso in US market
Biopharma | April 08, 2026

Biocon launches denosumab biosimilars Bosaya and Aukelso in US market

Interchangeable biosimilars to Prolia and Xgeva target osteoporosis and cancer-related bone complications in a $5 billion U.S. market


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


Aurobindo Pharma’s CuraTeQ achieves Phase 3 success for Omalizumab biosimilar
Biopharma | April 07, 2026

Aurobindo Pharma’s CuraTeQ achieves Phase 3 success for Omalizumab biosimilar

The drug meets all primary endpoints across 608 patients in Europe and India, strengthening the company's biosimilars pipeline


HRV Pharma, Shodhana join hands to build next-gen API pipeline for global markets
News | April 07, 2026

HRV Pharma, Shodhana join hands to build next-gen API pipeline for global markets

Multi-year CDMO partnership combines AI-led virtual development, precision chemistry and GMP manufacturing to accelerate five high-science APIs across regulated markets


Enveric Biosciences bags key US patent for mental health drug
Biotech | April 06, 2026

Enveric Biosciences bags key US patent for mental health drug

EB-003 is Enveric’s lead neuroplastogen, a 5-HT2A / 5-HT1B dual-acting compound designed to promote neuroplastic changes


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


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