Drug Approval | December 08, 2023
Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH
Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions
Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions
The inspection of the facility conducted from August 7 to August 11, 2023
The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally
The company through its IPO will fetch Rs 1475.26 crore - Rs 1550.59 crore at the lower and upper end of the price band.
NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
Company's Unit - IX, an API intermediate facility situated at Sangareddy District, Telangana, has now been classified as Voluntary Action Indicated
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
NULIBRY is a first-in-class cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A.
Doubling of median overall survival seen in QuANTUM-First results presented at EHA Presidential Symposium
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