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RSS FeedPosted by Michael Wonder on 08 May 2019
European Commission approves Lorviqua (lorlatinib) for certain adult patients with previously treated ALK positive advanced non-small cell lung cancer
7 May 2019 - Pfizer today announced that the European Commission granted conditional marketing authorisation for Lorviqua (lorlatinib, available in ...
Posted by Michael Wonder on 08 May 2019
Dupixent (dupilumab) approved for severe asthma by European Commission
7 May 2019 - Only biologic approved in the European Union for severe asthma with type 2 inflammation, as characterised by ...
Posted by Michael Wonder on 08 May 2019
Akcea and Ionis announce approval of Waylivra (volanesorsen) in the European Union
7 May 2019 - Akcea Therapeutics and Ionis Pharmaceuticals announced today that Waylivra has received conditional marketing authorisation from the ...
Posted by Michael Wonder on 08 May 2019
Medicines Australia welcomes ALP R&D investment pledge
8 May 2019 - Medicines Australia welcomes today’s announcement from the Australian Labor Party to reform the Research and Development ...
Posted by Michael Wonder on 08 May 2019
FDA grants CytoDyn fast track designation for leronlimab (PRO 140) in metastatic triple-negative breast cancer, an unmet medical need
7 May 2019 - CytoDyn today announced that the U.S. FDA has granted fast track designation to leronlimab (PRO140) for ...
Posted by Michael Wonder on 08 May 2019
RedHill Biopharma submits new drug application for Talicia for H. pylori Infection
7 May 2019 - RedHill Biopharma today announced that, following a positive pre-NDA meeting held recently with the U.S. FDA, ...
Posted by Michael Wonder on 07 May 2019
Working together for safe medicines in the EU
6 May 2019 - EMA launches a social media campaign to highlight how the European medicines regulatory network keeps medicines ...
Posted by Michael Wonder on 07 May 2019
In a crafty move, FDA may have found a way to dampen controversy over a $375,000 rare disease drug
6 May 2019 - The FDA just added an unexpected twist to a simmering controversy over a rare disease drug ...
Posted by Michael Wonder on 07 May 2019
European Commission approves Palynziq (pegvaliase injection) for treatment of phenylketonuria in patients aged 16 years or older
6 May 2019 - First enzyme substitution therapy approved in Europe to treat the underlying cause of phenylketonuria in patients aged ...
Posted by Michael Wonder on 07 May 2019
Zynerba Pharmaceuticals receives fast track designation for Zygel for the treatment of behavioural symptoms associated with Fragile X syndrome
6 May 2019 - Enrolment progressing in pivotal CONNECT-FX trial of Zygel in Fragile X syndrome, with data expected in the ...
Posted by Michael Wonder on 07 May 2019
Savara announces Molgradex received fast track designation by FDA for treatment of auto-immune pulmonary alveolar proteinosis
6 May 2019 - Savara today announced that the U.S. FDA granted fast track designation for Molgradex, an inhaled formulation ...
Posted by Michael Wonder on 07 May 2019
FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare auto-immune disorder
6 May 2019 - The U.S. FDA today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome in patients ...
Posted by Michael Wonder on 06 May 2019
Pfizer gets U.S. approval for $225,000/year heart drug
6 May 2019 - The U.S. FDA on Monday approved Pfizer's oral drug, tafamidis, to treat a rare and fatal heart ...
Posted by Michael Wonder on 06 May 2019
FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin‑mediated amyloidosis
6 May 2019 - On May 3, the U.S. FDA approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment ...
Posted by Michael Wonder on 06 May 2019
Esperion announces U.S. FDA acceptance of new drug applications for both bempedoic acid and the bempedoic acid with ezetimibe combination tablet for filing and regulatory review
5 May 2019 - 21 February 2020 PDUFA target date goal for bempedoic acid and 26 February 2020 PDUFA target ...