US FDA
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U.S. regulators approved AstraZeneca’s key immunotherapy drug durvalumab as a treatment for bladder cancer
May 3, 2017News Hour: U.S. regulators have approved AstraZeneca’s key immunotherapy drug durvalumab as a treatment for bladder cancer, marking the first commercial green light for a product the company hopes will go on to sell billions of... -
US FDA accepted Novartis’s BLA filing and granted priority review for CTL019
Apr 2, 2017News Hour: Novartis announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) filing and granted priority review for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T-cell (CAR-T) therapy,... -
A new leukemia treatment from Novartis to get priority review from the US FDA
Mar 31, 2017News Hour: A new leukemia treatment from Novartis for children and young adults will get priority review from the U.S. Food and Drug Administration (FDA), putting the Swiss drugmaker ahead of rivals working on similar cancer... -
Novartis won the approval of US FDA for Kisqali to treat Breast Cancer patient
Mar 14, 2017News Hour: Novartis has won U.S. Food and Drug Administration approval for Kisqali to treat postmenopausal women who have a difficult-to-treat form of breast cancer, challenging U.S. rival Pfizer’s Ibrance. The Swiss company has priced Kisqali... -
India’s Sun Pharmaceutical Industries said U.S. regulators plan to lift a ban on its Mohali plant
Mar 14, 2017News Hour: India’s largest drugmaker Sun Pharmaceutical Industries said U.S. regulators plan to lift a ban on its Mohali plant in northern India, paving the way for a resumption of exports to the company’s biggest market... -
The US FDA grants priority review to Novartis drug Zykadia
Feb 23, 2017News Hour: The U.S. Food and Drug Administration (FDA) has granted priority review to Novartis drug Zykadia as a first-line treatment for some lung cancer patients, the Swiss drugmaker said on Thursday. The priority review covers... -
Sanofi’s Xyzal® Allergy 24HR approved for over-the-counter use in the United States
Feb 2, 2017News Hour: Sanofi announced that the U.S. Food and Drug Administration (FDA) approved Xyzal® Allergy 24HR as an over-the-counter (OTC) treatment for the relief of symptoms associated with seasonal and year-round allergies. Specifically, two formulations of... -
FDA warned consumers against using certain homeopathic teething products
Jan 28, 2017News Hour: The U.S. Food and Drug Administration on Friday warned consumers against using certain homeopathic teething products, saying it has found high amounts of a toxic substance in some of them and they pose a... -
US FDA approves Portola’s NDA for priority review
Dec 24, 2016News Hour: Portola Pharmaceuticals, Inc.® announced that the U.S. Food and Drug Administration (FDA) accepted Portola’s New Drug Application (NDA) granting priority review for betrixaban, an oral, once-daily Factor Xa inhibitor anticoagulant, for extended-duration prophylaxis of venous... -
U.S. FDA approves Biogen’s SPINRAZA™, the first treatment for spinal muscular atrophy
Dec 24, 2016News Hour: The U.S. Food and Drug Administration (FDA) approved Biogen’s SPINRAZA™ (nusinersen) under Priority Review for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is the first and only treatment approved...
