In a recent study published in the journal Nature Medicine, an international team of researchers evaluated the efficacy, safety, and tolerability of extended-release ketamine tablets (R-107) in adult ...

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved ...

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved memantine/donepezil ...

AHMEDABAD, India--(BUSINESS WIRE)--Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) announces the launch of ...

Pfizer Inc. announced today that the U.S. Food and Drug Administration has approved XELJANZ ® XR extended-release 11 mg and 22 mg tablets for the once-daily treatment of adult patients with moderately ...

MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)--Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and ...

Granules India Ltd on Thursday said its arm Granules Pharmaceuticals, Inc has received tentative approval from the US health regulator for its generic amphetamine extended-release tablets indicated ...

Credit: FDA. The letter states that the application cannot be approved in its present form. The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Incyte regarding the ...

TNX-601 ER is a Once-Daily Tablet that is Bioequivalent to Three-Times-Daily Tianeptine Sodium Immediate Release (IR) that has been available in Europe, Asia and Latin America for More than Three ...

In a new cohort of 27 adults from the IMPACT-TD Registry, up to 77% of participants reported improvements in aspects of their lives impacted by tardive dyskinesia (TD) while taking AUSTEDO or AUSTEDO ...

Sandoz is recalling 13 lots of the pain relief drug Orphenadrine Citrate in 100 mg extended release tablets after testing found the carcinogen nitrosamine and the lots might have too much of it.