Blog
RSS FeedPosted by Michael Wonder on 10 May 2016
U.S. FDA expands Imbruvica (ibrutinib) label to include overall survival data in previously untreated chronic lymphocytic leukaemia and new indication for small lymphocytic lymphoma patients
9 May 2016 - AbbVie today announced the U.S. FDA updated the Imbruvica (ibrutinib) Prescribing Information to include new data from ...
Posted by Michael Wonder on 09 May 2016
Jadenu (deferasirox) for the management of chronic iron overload is now available in Canada
6 May 2016 - Canadians requiring treatment for chronic iron overload have a new treatment option with the availability of Jadenu ...
Posted by Michael Wonder on 05 May 2016
European Commission approves Halaven (eribulin mesylate) for treatment of advanced liposarcoma in Europe
5 May 2016 - People with advanced liposarcomas in Europe may now be able to receive Halaven (eribulin mesylate), the first ...
Posted by Michael Wonder on 05 May 2016
FDA grants priority review for Lilly's olaratumab, an investigational medicine for advanced soft tissue sarcoma
4 May 2016 - Eli Lilly announced today that the U.S. FDA has granted priority review for the biologics license application ...
Posted by Michael Wonder on 05 May 2016
Ferring Pharmaceuticals announces approval for Nocdurna, a new therapeutic option for the treatment of adults waking multiple times to urinate at night
3 May 2016 - Ferring Pharmaceuticals today announced that Nocdurna (desmopressin) has received approval in the EU for the symptomatic treatment ...
Posted by Michael Wonder on 04 May 2016
FDA grants priority review for Amgen's supplemental biologics license application for Blincyto (blinatumomab)
3 May 2016 - Amgen today announced that the US FDA has accepted for priority review the supplemental biologics license application ...
Posted by Michael Wonder on 04 May 2016
Health Canada approves Lynparza for the treatment of ovarian cancer in patients with BRCA mutations
3 May 2016 - AstraZeneca Canada announced today that Health Canada has approved Lynparza (olaparib) capsules as a maintenance treatment for ...
Posted by Michael Wonder on 03 May 2016
Eisai announces FDA approval of Fycompa (perampanel) oral suspension for adjunctive therapy in the treatment of partial-onset seizures and primary generalized tonic-clonic seizures
2 May 2016 - Eisai Inc. today announced that the U.S. FDA has approved Fycompa (perampanel) oral suspension as adjunctive therapy ...
Posted by Michael Wonder on 03 May 2016
Flamel Technologies receives FDA approval of Akovaz
2 May 2016 - Flamel Technologies today announced that the U.S. FDA has approved the Company’s new drug application for ...
Posted by Michael Wonder on 02 May 2016
April 2016 NCE registrations - TGA
2 May 2016 - The TGA registered two new chemical entities (medicines) and two new blood products in April 2016. ...
Posted by Michael Wonder on 02 May 2016
AusPARs user survey
2 May 2016 - The TGA would like to know what you think about the AusPARs for prescription medicines. ...
Posted by Michael Wonder on 01 May 2016
Teva announces FDA approval of ProAir RespiClick (salbutamol sulphate) inhalation powder for paediatric asthma patients ages 4 to 11
29 April 2016 - Teva Pharmaceuticals announced today that the U.S. FDA has approved ProAir RespiClick (salbutamol sulphate) inhalation powder for ...
Posted by Michael Wonder on 01 May 2016
Highlights from the CHMP 25-28 April 2016 meeting
29 April 2016 - Six medicines, including one new antibacterial, recommended for authorisation in the EU. ...
Posted by Michael Wonder on 01 May 2016
FDA approves first drug to treat hallucinations and delusions associated with Parkinson’s disease
29 April 2016 - The U.S. FDA today approved Nuplazid (pimavanserin tartrate), the first drug approved to treat hallucinations and delusions ...
Posted by Michael Wonder on 01 May 2016
Novartis drug Afinitor recommended by CHMP to treat select GI and lung neuroendocrine tumors
29 April 2016 - Novartis today announced that the CHMP of the EMA adopted a positive opinion for Afinitor (everolimus) for the ...