Johnson & Johnson gets FDA nod for new depression treatment

This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials

Touchlight unveils next-gen circular DNA portfolio for advanced gene therapies

The expanded mbDNA portfolio delivers enhanced stability, reduced immunogenicity, and broad compatibility with gene insertion and expression technologies

Relmada gains FDA backing for two registrational trials and reports 92% response with NDV-01 in bladder Cancer

Relmada expects to initiate its Phase 3 program in the first half of 2026

Venus Remedies expands ASEAN presence with new drug approvals in Vietnam

Venus Remedies now has 29 active product approvals in Vietnam alone

Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'

The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases

Alembic announces USFDA final approval for Dasatinib Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets

Zydus Lifesciences secures FDA tentative approval for Olaparib tablets

Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers

Alembic receives FDA final approval for Sumatriptan Injection USP

Sumatriptan injection is indicated in adults for the acute treatment of migraine

Amgen confident in US biosimilar market’s strength as sales surge 52%

Senores Pharma forms new subsidiary in US

Senores Pharmaceuticals (SPI) acquired 51% stake in Zoraya Pharmaceuticals