Pfizer announced that the FDA has accepted for review the NDA for Xeljanz (tofacitinib citrate) 11mg once daily modified release tablets for the treatment of moderate to severe rheumatoid arthritis in patients with inadequate response or intolerance to methotrexate.
All articles by Mital Patel, PharmD
Pfizer and Eli Lilly and Company announced that they are preparing to resume the Phase 3 clinical pain program for tanezumab.
Ocular Therapeutix announced positive data from the first of two phase 3 clinical trials evaluating the safety and efficacy of sustained release dexamethasone.
The FDA has issued a letter for the sNDA for the use of bupivacaine liposome injectable suspension in nerve block to provide postsurgical analgesia.
The FDA has accepted the NDA for review for Belbuca buccal film for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
Eli Lilly and Company and Incyte announced results from a second Phase 3 trial with baricitinib in patients with rheumatoid arthritis.
The FDA has accepted for review the New Drug Application (NDA) for ALO-02 (oxycodone HCl and naltrexone HCl; Pfizer) extended-release capsules.
FDA has accepted filing for NDA for MorphaBond ER.
Pfizer announced results from a phase-3 study evaluating pregabalin controlled-release (CR) formulation in adult patients with postherpetic neuralgia (PHN).
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