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15 June 2016 | By Victoria White, Digital Content Producer
The FDA has approved a higher strength 20mg capsule of Sobi's Orfadin (nitisinone) for the treatment of Hereditary Tyrosinaemia type-1 (HT-1)...
7 June 2016 | By Victoria White, Digital Content Producer
Byvalson is the first and only fixed-dose combination (FDC) of a beta blocker (BB) and angiotensin II receptor blocker (ARB) available in the US...
3 June 2016 | By Victoria White, Digital Content Producer
The FDA has granted accelerated approval to Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis...
26 May 2016 | By Victoria White, Digital Content Producer
The FDA's EMDAC has recommended the approval of the NDA for the fixed-ratio combination of insulin glargine and lixisenatide...
23 May 2016 | By Victoria White, Digital Content Producer
Helperby is about to begin clinical studies of a completely new approach to fighting resistant bacteria following a positive meeting with the FDA...
12 May 2016 | By Victoria White, Digital Content Producer
The FDA has granted Orphan Drug Designation for selumetinib for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC)...
9 May 2016 | By Victoria White, Digital Content Producer
MGB Biopharma presented Phase I and preclinical data together with a proposal for the further development of oral MGB-BP-3 in C. difficile infections...
4 May 2016 | By Victoria White, Digital Content Producer
The US Food and Drug Administration (FDA) has granted Priority Review to Lilly’s biologics license application (BLA) for olaratumab, in combination with doxorubicin, for the potential treatment of people with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery.
3 May 2016 | By Victoria White, Digital Content Producer
The FDA has approved Acadia’s Nuplazid, the first drug approved to treat hallucinations and delusions experienced by some people with Parkinson’s disease...
27 April 2016 | By Mandy Parrett, Editorial Assistant
Novartis announced today that the FDA has granted three breakthrough therapy designations for Ilaris® (canakinumab) to treat rare types of Periodic Fever Syndromes, also known as Hereditary Periodic Fevers.
25 April 2016 | By Victoria White, Digital Content Producer
The designation is based on results of a Phase III trial evaluating Opdivo versus investigator’s choice of therapy in patients with SCCHN...
21 April 2016 | By Victoria White, Digital Content Producer
RedHill Biopharma has concluded a positive Type B Meeting with the FDA regarding the path to marketing approval of RHB-105...
15 April 2016 | By Victoria White, Digital Content Producer
The FDA has accepted a sBLA for Opdivo that seeks to expand the use of the therapy to patients with Hodgkin Lymphoma after prior therapies...
13 April 2016 | By Victoria White, Digital Content Producer
The sBLA is for patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy...
13 April 2016 | By Victoria White, Digital Content Producer
The FDA has approved Epigenomics’ lead product, Epi proColon, the first and only FDA-approved blood-based colorectal cancer screening test...
