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.
There were as many billion-dollar brands in 2017 as there have been in any other calendar year despite the cratering effects of massive patent cliffs in 2012 and 2015.
The top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.
The U.S. FDA approved AstraZeneca Plc’s treatment for hairy cell leukemia, a slow-growing type of blood cancer.
FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA), a Rare Form of Juvenile Arthritis
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.
Hutchison China MediTech won Chinese approval for a closely watched new cancer drug in a significant boost for “made in China” medicine.
The U.S. FDA approved Bayer AG’s long-acting treatment for hemophilia A, a rare genetic disorder in which blood does not clot easily.
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.
Novartis received European approval for Kymriah, the Swiss drugmaker’s gene-modifying therapy for blood cancer.
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 a first-of-its-kind drug from Shire Plc to treat patients aged 12 and older suffering from a rare hereditary disease that causes swelling.
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.
Roche’s Alecensa lung cancer medicine became the latest beneficiary of China’s efforts to speed up approvals in the world’s second-biggest drug market, which is gaining importance for global pharmaceuticals companies’ growth plans.
Days after rejecting Regeneron’s attempt to secure a supplemental approval for Eylea, the FDA approved a new dosing label for the drug in wet age-related macular degeneration (wet AMD).
The Food and Drug Administration approved Bristol-Myers Squibb’s Opdivo for patients whose lung cancer had progressed even after undergoing chemotherapy and at least one other therapy.
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.
The U.S. Food and Drug Administration approved Teva Pharmaceutical Industries Ltd.’s generic version of Mylan NV’s life-saving allergy injection EpiPen.
Sun Pharmaceutical Industries Ltd. received FDA approval for Cequa (cyclosporine ophthalmic solution) 0.09% to increase tear production in patients with keratoconjunctivitis sicca.
FDA Clears SPR Therapeutics’ Non-opioid SPRINT endura and extensa Peripheral Nerve Stimulation Systems for Pain Management
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.
U.S. health regulators expanded the use of Vertex Pharmaceuticals Inc.’s cystic fibrosis drug Kalydeco to include patients aged between 12 months and 24 months.
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.
U.S. health regulators approved Amicus Therapeutics’ Galafold as the first oral therapy to treat Fabry disease, a rare and sometimes fatal condition.