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Results For "Food-and-Drug-Administration"

1346 News Found

Merck strikes $6.7 billion deal to acquire terns, bolstering cancer pipeline
News | March 26, 2026

Merck strikes $6.7 billion deal to acquire terns, bolstering cancer pipeline

TERN-701, a next-generation therapy targeting chronic myeloid leukemia (CML), a form of blood cancer that still presents treatment challenges despite decades of advances


FDA nod to Johnson & Johnson’s oral psoriasis therapy 'ICOTYDE'
News | March 25, 2026

FDA nod to Johnson & Johnson’s oral psoriasis therapy 'ICOTYDE'

New targeted pill offers hope for adults and teens with moderate-to-severe plaque psoriasis


Bristol Myers Squibb scores major win with new Opdivo nods for Hodgkin Lymphoma in US, EU
News | March 21, 2026

Bristol Myers Squibb scores major win with new Opdivo nods for Hodgkin Lymphoma in US, EU

These approvals represent a defining moment for people living with classical Hodgkin Lymphoma


Roche breaks lab barriers as FDA clears mass spec tests for wider use
News | March 20, 2026

Roche breaks lab barriers as FDA clears mass spec tests for wider use

The newly classified assays join Roche’s Ionify 25-Hydroxy Vitamin D total assay in a growing U.S. portfolio


Lilly expands access to Zepbound weight-loss drug with $299 monthly self-pay option
News | March 17, 2026

Lilly expands access to Zepbound weight-loss drug with $299 monthly self-pay option

The expanded program allows patients to fill prescriptions either at a local pharmacy or through home delivery via LillyDirect


Zydus receives USFDA approval for cevimeline hydrochloride capsules
Drug Approval | March 14, 2026

Zydus receives USFDA approval for cevimeline hydrochloride capsules

Cevimeline Hydrochloride Capsules 30mg are indicated for the symptomatic treatment of dry mouth (xerostomia) associated with Sjögren’s syndrome.


APL Healthcare’s Unit-IV classified as VAI by the USFDA
News | March 14, 2026

APL Healthcare’s Unit-IV classified as VAI by the USFDA

This inspection is now closed


Shilpa Biologicals and mAbTree Biologics secure ODD from USFDA
Drug Approval | March 13, 2026

Shilpa Biologicals and mAbTree Biologics secure ODD from USFDA

Marks significant milestone for breakthrough biologic to treat rare blood cancers


FDA nod to first treatment for rare genetic brain disorder
Drug Approval | March 12, 2026

FDA nod to first treatment for rare genetic brain disorder

The approval comes after a systematic review of published literature