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21 July 2015 | By Victoria White
The FDA has granted Breakthrough Therapy Designation to BMS-663068 for the treatment of HIV-1 infection in heavily treatment-experienced adult patients...
20 July 2015 | By Victoria White
The US FDA has granted C2N-8E12 (ABBV-8E12) an orphan drug designation for the treatment of progressive supranuclear palsy (PSP)...
20 July 2015 | By Victoria White
The FDA has approved Novo Nordisk’s FlexPro PenMate, designed for users of Norditropin FlexPro pens who dislike needles and prefer them to be hidden...
15 July 2015 | By Victoria White
Takeda has submitted an NDA to the US FDA for ixazomib for the treatment of patients with relapsed and/or refractory multiple myeloma...
15 July 2015 | By Victoria White
Both Mylan and Dr. Reddy's have launched Memantine hydrochloride tablets USP, 5 mg and 10 mg, which is the generic version of Namenda Tablets, in the US...
14 July 2015 | By Victoria White
The FDA has released the first doses of Sanofi Pasteur’s Fluzone influenza vaccine for shipment for the 2015-2016 influenza season in the US...
14 July 2015 | By Victoria White
The FDA has approved Iressa for the first-line treatment of patients with NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutations...
10 July 2015 | By Victoria White
Lilly has issued a statement in response to the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee’s ongoing review of necitumumab...
9 July 2015 | By Victoria White
Teva has launched generic Axert® (almotriptan malate) tablets in the US for the treatment of migraine attacks in adults and adolescents...
8 July 2015 | By Victoria White
Lilly’s NSCLC drug, necitumumab, has raised concerns with the FDA after trial data suggested that the drug might increase the likelihood of fatal clots...
3 July 2015 | By Victoria White
The FDA has approved Vertex’s Orkambi, the first medicine to treat the underlying cause of cystic fibrosis in people with two copies of the F508del mutation...
3 July 2015 | By Victoria White
The FDA has accepted for review Pfizer’s new drug application (NDA) for Xeljanz (tofacitinib citrate) 11 mg once daily modified release tablets...
30 June 2015 | By Victoria White
Intercept Pharmaceuticals has achieved two important regulatory milestones for obeticholic acid in primary biliary cirrhosis (PBC)...
17 June 2015 | By Victoria White
The FDA has approved ZOMIG Nasal Spray for use in the US in paediatric patients 12 years of age and older for the treatment of migraine with or without aura...
10 June 2015 | By Victoria White
The FDA has granted Breakthrough Therapy designation status to Roche’s ACTEMRA/RoACTEMRA (tocilizumab) for systemic sclerosis (SSc)...
