Drug Approval | 25 February 2023
Pfizer’s Elranatamab receives FDA and EMA filing acceptance
Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma
Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma
Clinical studies are expected to start in Q2 2023.
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
Cipla has received 8 inspectional observations in Form 483
Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States
Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival
FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients
Sirolimus Tablets had annual sales of USD 69 million in the United States (IQVIA MAT Dec. 2022)
According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately US $122.3 million
Themis will market this drug with the brand name REMITHEM.
Durvalumab in combination with chemotherapy is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer
Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya
Label expansion for CIBINQO provides new systemic oral option for adolescents (12 to <18 years) with moderate-to-severe atopic dermatitis
Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.
The Tc 99m Mertiatide Injection is used in the diagnosis of congenital and acquired renal abnormalities
DETAF would be a welcome new addition in the management of HIV infections and will be available for supplies to low- and middle-income countries
CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%
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