FDA Sets New Action Date To Review NDA For Exalgo
Covidien has reported that the FDA has set a new action date, under the Prescription Drug User Fee Act for the review of the New Drug Application (NDA)

Covidien has reported that the FDA has set a new action date, under the Prescription Drug User Fee Act for the review of the New Drug Application (NDA)

Boston Scientific has received 510(k) clearance from the FDA and CE Mark approval to market its WallFlex fully covered esophageal stent for the treatment of malignant esophageal strictures

Pozen has initiated the enrollment for the Phase 3 studies for PA32540. PA32540 is a fixed-dose combination of 325mg of enteric coated aspirin and 40mg of immediate release

Merck & Co has reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of Elonva (corifollitropin alfa

Pfizer has received FDA approval for Revatio (sildenafil) injection, an intravenous formulation of Revatio. Revatio is the FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations.

Nutra Pharma has introduced Nyloxin OTC, an over-the-counter (OTC) drug for the treatment of chronic pain. Nyloxin OTC will be marketed and sold internationally alongside the company’s prescription

“Despite recent challenges, we have seen several positive signs,” commented Mr. Xiaodong Wu, Chairman and Chief Executive Officer of the Company. “In the past quarter, we received SFDA

Keystone Folding Box has announced the appointment of new director for marketing. Ward Smith, new director, will be responsible for development of compliance packaging and applications for clinical

ImmuPharma has announced the final results from a Phase IIb trial of Lupuzor in active patients with Systemic Lupus Erythematosus (SLE). Lupuzor administered at 200mcg once-a-month for 3

Basilea has presents new research data on its anti-tumor drug candidate BAL27862 at the international conference on Molecular Targets and Cancer Therapeutics in Boston (MA). The new data