Mylan Pharma gets USFDA nod for Breyna for Generic Version of Symbicort MD Bureau17 March 2022 3:29 PM ISTViatris Inc. and Kindeva Drug Delivery L.P. today announced that Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug...
Niramai gets USFDA nod for medical device SMILE-100 System MD Bureau16 March 2022 5:19 PM ISTNiramai Health Analytix, the deep-tech Bangalore-based healthcare company offering a novel radiation-free, non-touch, accurate, breast cancer...
Alembic Pharma receives USFDA Tentative Approval for Macitentan MD Bureau16 March 2022 3:42 PM ISTThe tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Opsumit Tablets, 10 mg, of Actelion...
Zydus Lifesciences gets USFDA nod for Colestipol Hydrochloride Tablets MD Bureau16 March 2022 3:41 PM ISTColestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with...
No USFDA approval for AstraZeneca's treatment for chronic nasal condition MD Bureau15 March 2022 3:02 PM ISTThe London-listed drugmaker said the U.S. Food and Drug Administration (FDA) had issued a complete response letter following AstraZeneca's application...
Zydus Lifesciences gets USFDA nod to market colestipol hydrochloride tablets MD Bureau14 March 2022 2:26 PM ISTThe approval by the US Food and Drug Administration is for colestipol hydrochloride of 1 mg strength, the company said in a regulatory filing.
AstraZeneca and Merck's Lynparza gets USFDA nod MD Bureau14 March 2022 11:29 AM ISTThe approval by the US Food and Drug Administration (FDA) was based on results from the OlympiA Phase III trial presented during the 2021 American...
Bayer Submits Application for NUBEQA to USFDA and EMA MD Bureau12 March 2022 2:45 PM ISTBayer today announced the submission of a supplemental new drug application to the U.S. Food and Drug Administration USFDA as well as the submission...
Strides Pharma gets USFDA nod for colchicine tablets MD Bureau12 March 2022 10:17 AM ISTStrides said the product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market.
USFDA asks Philips Respironics to notify patients about ventilator recall MD Bureau12 March 2022 10:17 AM IST"Taking this action today enables the FDA to mandate that Philips Respironics improve its communication about the recall and the serious risk posed by...
USFDA issues 3 observations for Zydus Lifesciences's Vadodara plant MD Bureau11 March 2022 2:36 PM IST"We are confident of addressing and resolving the issues to the satisfaction of USFDA. We remain committed to building a quality culture across our...
Alembic JV Aleor Dermaceuticals receives USFDA nod for Nystatin and Triamcinolone Acetonide Ointment MD Bureau9 March 2022 11:15 AM ISTNystatin and Triamcinolone Acetonide Ointment has an estimated market size of US$4 million for twelve months ending Dec 2021 according to IQVIA.
