Theravance Biopharma Inc. and partner Mylan NV won U.S. regulatory approval for their treatment Yupelri for a chronic lung condition that causes breathing-related problems.
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.
Bristol-Myers Squibb snagged regulatory approval from the U.S. FDA for Empliciti (elotuzumab) for adults with multiple myeloma who have received at least two prior therapies.
Merck’s blockbuster anti-PD-1 therapy Keytruda won FDA approval in combination with chemotherapy as a first-line treatment for patients with metastatic squamous non-small cell lung cancer.
The U.S. Food and Drug Administration approved Novartis AG’s copy of Humira, the world’s bestselling prescription medicine developed by U.S.-based AbbVie Inc.
The U.S. Food and Drug Administration approved TherapeuticsMD’s oral hormone therapy for menopause symptoms such as hot flashes, sleep disturbances and night sweats.
Japan’s Shionogi and Swiss drugmaker Roche won U.S. FDA approval for Xofluza, the first new flu drug approved by the regulatory agency in nearly 20 years.
Sanofi SA’s eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma.
The U.S. Food and Drug Administration approved Pfizer Inc.’s Talzenna (talazoparib) for an advanced form of breast cancer.
Bausch Health, formerly Valeant Pharmaceuticals, received tentative U.S. approval to market the plaque psoriasis lotion Bryhali.
The U.S. Food and Drug Administration approved Akcea Therapeutics’ rare genetic disease drug Tegsedi, which was developed along with Ionis Pharmaceuticals.
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. Food and Drug Administration approved Antares Pharma Inc.’s injectable drug Xyosted to treat low testosterone levels in men nearly a year after being rejected.
Shares of Verastem climbed following U.S. regulatory approval for the leukemia drug Copiktra, an inhibitor of phosphoinositide 3-kinase-delta and PI3K-gamma.
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.
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.