The U.S. FDA approved Paratek Pharmaceuticals Inc.’s Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia and acute skin and skin structure infections.

The U.S. FDA approved the New Drug Application of Xelpros 0.005% for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Roche Group member Genentech announced today that the U.S. FDA approved the subcutaneous formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

The Janssen Pharmaceutical Companies of J&J announced the U.S. FDA approval of Imbruvica (ibrutinib) in combination with rituximab for the treatment of Waldenström’s macroglobulinemia.

The U.S. FDA approved Ortho Dermatologics’ NDA for Altreno (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

The U.S. FDA approved an expanded label for Merck’s anti-PD-1 therapy Keytruda in combination with Alimta (pemetrexed) and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations, based on results of the KEYNOTE-189 trial.

Eisai and Merck announced that the U.S. FDA approved the kinase inhibitor Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma.

Sun Pharmaceutical Industries Ltd. received FDA approval for Cequa (cyclosporine ophthalmic solution) 0.09% to increase tear production in patients with keratoconjunctivitis sicca.

SPR Therapeutics Inc., a leader in neurostimulation technology for pain, announced that the U.S. Food and Drug Administration cleared the company’s SPRINT endura (single lead) and extensa (dual lead) Peripheral Nerve Stimulation Systems.

Genentech announced that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for Xolair (omalizumab) for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies.