FDA Approvals

The U.S. Food and Drug Administration has officially approved a new brain tumour treatment developed by Jazz Pharmaceuticals. The medication, called Modeyso, has been...

Taiwan Grants Full Approval for NEFECON IgAN Treatment

Asia

Everest Medicines, a biopharmaceutical company dedicated to advancing innovative therapies, has announced that Taiwan’s Food and Drug Administration (TFDA) has granted full approval for...

Aptar Pharma Bolsters Clinical Trial Capabilities with Strategic Materials Manufacturing Acquisition

Clinical Trials

Aptar Pharma, a global leader in drug delivery and active material science solutions and services, announced its acquisition of the clinical trial materials manufacturing...

FDA Accepts BLA for Recommended Biosimilar to Simponi

FDA Approvals

Bio-Thera Solutions announced that the FDA has accepted its Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi® (golimumab). The FDA goal...

FDA Approves Oral Therapy for Treating Hereditary Angioedema

FDA Approvals

The US Food and Drug Administration (FDA) has approved the first on-demand oral therapy for the treatment of acute attacks of hereditary angioedema (HAE)...

Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia

Drug Development

Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, announced on June 5 2025, that LUMRYZTM has been granted Orphan...

Stringent Policy around COVID Vaccines Laid by FDA

FDA Approvals

The US FDA is now tightening its regulatory policy around COVID vaccines by setting up a new framework that raises the bar for certain...

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