FDA approves Pfizer’s biosimilar to Roche’s Herceptin
FILE PHOTO: The logo of U.S. pharmaceutical corporation Pfizer Inc. is seen at a branch in Zurich, Switzerland October 2, 2018. REUTERS/Arnd Wiegmann (Reuters) – The U.S. Food and Drug…
J&J nasal spray gets U.S. approval as first new type of anti-depressant in decades
(Reuters) – The U.S. Food and Drug Administration on Tuesday said it approved a Johnson & Johnson nasal spray antidepressant for people resistant to other treatments but placed restrictions on…
FDA chief tough on e-cigs steps down in surprise resignation
WASHINGTON (Reuters) – U.S. Food and Drug Administration Commissioner Scott Gottlieb said on Tuesday that he plans to step down next month, a sudden resignation that calls into question how…
New cancer-causing toxin found in recalled blood pressure pills
(Reuters) – U.S. health regulators said on Friday a third cancer-causing toxin was found in some blood pressure pills recalled by India’s Hetero Labs Ltd a day earlier, adding to…
Sanofi blood disorder drug wins FDA approval
(Reuters) – The U.S. Food and Drug Administration (FDA) said on Wednesday it had approved Sanofi SA’s drug to treat a rare blood-clotting disorder in adults in combination with standard-of-care…
FDA approves cheaper Botox rival to treat frown lines
(Reuters) – An injection that makes forehead wrinkles disappear is set to rival Allergan’s Botox after U.S. regulators approved Evolus Inc’s cheaper treatment on Friday. Evolus expects Jeuveau to be…
U.S. FDA approves Alexion Pharma’s blood disorder drug
(Reuters) – The U.S. Food and Drug Administration has approved Alexion Pharmaceuticals Inc’s blood disorder drug Ultomiris, the pharma regulator’s website showed on Friday. The drug aims to treat paroxysmal…
Sanofi drug Dupixent wins FDA approval to treat asthma
(Reuters) – France’s Sanofi SA said on Friday eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types…
Insmed’s treatment-resistant lung disease drug gets FDA approval
(Reuters) – The U.S. Food and Drug Administration on Friday approved Insmed Inc’s lead drug to treat a rare, chronic lung disease, making it the first approved treatment in the…
U.S. regulator approves Teva migraine drug, shares rise
(Reuters) – Shares of Israeli drugmaker Teva Pharmaceutical Industries rose over 5 percent in after-hours trading on Friday after the U.S. Food and Drug Administration (FDA) approved the company’s new…