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12 April 2016 | By Victoria White, Digital Content Producer
Venclexta is the first FDA-approved treatment that targets the BCL-2 protein, which supports cancer cell growth and is overexpressed in many CLL patients...
11 April 2016 | By Victoria White, Digital Content Producer
The FDA has granted a priority review for atezolizumab for the treatment of locally advanced or metastatic NSCLC that expresses the protein PD-L1...
6 April 2016 | By Victoria White, Digital Content Producer
With this approval, Celltrion's Inflectra becomes the first biosimilar monoclonal antibody (mAb) medication to receive approval in the US...
31 March 2016 | By Victoria White
Actinium’s Iomab-B is a radioimmunotherapeutic that conditions relapsed and refractory AML patients for a haematopoietic stem cell transplant...
29 March 2016 | By Victoria White
The FDA have issued a CRL to include new data in the clinical trials section of the US label of Brintellix for treating aspects of cognitive dysfunction in MDD...
24 March 2016 | By Victoria White
Aprecia’s Spritam (levetiracetam) tablets, for oral suspension, are now available in the US as an adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures.
23 March 2016 | By Victoria White
Taltz (ixekizumab) is intended for adult patients who are candidates for systemic therapy, phototherapy or a combination of both...
17 March 2016 | By Victoria White
Allergan believes it is a first applicant to file an ANDA for generic Abraxane and, should it be approved, may get 180 days of generic market exclusivity...
16 March 2016 | By Victoria White
Absorb is a first-of-its-kind bioresorbable device for the treatment of coronary artery disease. It dissolves completely after 2 to 3 years...
15 March 2016 | By Victoria White
The priority review is based on results of the IMvigor 210 study that evaluated the safety and efficacy of atezolizumab in people with locally advanced or metastatic urothelial carcinoma, regardless of PD-L1 expression.
14 March 2016 | By Victoria White
The approval is based on a Phase I study that included 50 patients with ROS1-positive metastatic NSCLC treated with 250 mg of Pfizer's Xalkori (crizotinib) orally twice daily...
8 March 2016 | By Victoria White
The approval expands the use of Faslodex and offers additional options for US women with HR+, HER2- metastatic breast cancer…
8 March 2016 | By Victoria White
The FDA has accepted for review a new supplemental Biologics License (sBLA) for Merck’s Keytruda (pembrolizumab) to include data from KEYNOTE-010...
7 March 2016 | By Victoria White
MedImmune has received Fast Track designation from the FDA for MEDI8852 for the treatment of patients hospitalised with Type A strain influenza...
2 March 2016 | By Victoria White
The sBLA includes new data supporting the treatment of paediatric and adolescent patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL)...
