This approval adds to Granules India's existing 67 ANDA approvals from the US FDA, strengthening its position in regulated ...

The expanded approval intensifies the rivalry with Jazz Pharmaceuticals, which has previously attempted to block Lumryz’s ...

The FDA was expected to decide on the application of sotorasib and panitumumab for the treatment of metastatic colorectal ...

Avadel Pharmaceuticals plc AVDL announced that the FDA has approved its supplemental new drug application (sNDA) seeking ...

Lo, PhD, has been appointed the new Editor-in-Chief of the journal ASSAY and Drug Development Technologies. Dr. Lo is ...

After two previous failed attempts with the FDA, AbbVie now has one more offering in its lineup — a critical step as it ...

Lumryz is the only FDA-approved once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in children ...

The FDA has accepted a new drug application for the intravesical solution of UGN-102 in low-grade intermediate-risk ...

The FDA recently declined to approve MDMA-assisted therapy for PTSD, but experts said there are many other treatments on the ...

The FDA approved the company's COVID vaccine in October 2023. The stock has gained 111% in the year to date, while the S&P 500 SPX has gained 22%. This content was created by MarketWatch, which is ...

A Prescription Drug User Fee Act target action date of June 13, 2025, has been set for the new drug application of ...

With the perpetual rise of technology and the proliferation of AI, we are moving faster than ever. New inventions have accelerated nearly every aspect of our lives, including medicine. In 2023, the ...