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RSS FeedPosted by Michael Wonder on 15 May 2018
FDA grants fast track designation for Yamo Pharmaceutical’s L1-79 in autism spectrum disorder
14 May 2018 - Yamo Pharmaceuticals announced today that the US FDA has granted fast track designation for its investigational ...
Posted by Michael Wonder on 13 May 2018
Perrigo expects complete response letter on generic version of ProAir
11 May 2018 - Perrigo today announced that it expects to receive a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 12 May 2018
Statement from FDA Commissioner on the Trump Administration’s plan to lower drug prices
11 May 2018 - Today is an important day in the Administration’s collaborative effort to address the rising cost of ...
Posted by Michael Wonder on 12 May 2018
FDA expands approval of Gilenya to treat multiple sclerosis in paediatric patients
11 May 2018 - The U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in ...
Posted by Michael Wonder on 10 May 2018
Games and greed delay the market entry of money-saving biosimilars
9 May 2018 - Generic medicines have saved Americans $1.67 trillion in the last decade. ...
Posted by Michael Wonder on 10 May 2018
AcelRx resubmits new drug application for Dsuvia
9 May 2018 - AcelRx Pharmaceuticals today announced the resubmission of the new drug application for DSUVIA with the U.S. ...
Posted by Michael Wonder on 09 May 2018
Forty Seven granted fast track designation for 5F9 for the treatment of diffuse large B-cell lymphoma and follicular lymphoma
3 May 2018 - Forty Seven today announced that the U.S. FDA has granted two fast track designations to its lead ...
Posted by Michael Wonder on 09 May 2018
FDA grants fast track designation to Debiopharm's Debio 1347 for the treatment of patients with unresectable or metastatic tumours with a specific FGFR gene alteration
8 May 2018 - Debiopharm announced today that the U.S. FDA has granted fast track designation to Debio 1347, an ...
Posted by Michael Wonder on 09 May 2018
Relypsa announces FDA approval of supplemental new drug application to enable the usage of Veltassa (patiromer) with or without food
8 May 2018 - Updated label may allow for increased dosing flexibility for patients with hyperkalaemia – a chronic, asymptomatic condition ...
Posted by Michael Wonder on 08 May 2018
Precision medicines have faster approvals based on fewer and smaller trials than other medicines
7 May 2018 - Precision medicines can benefit patients by increasing the probability of a successful treatment response in selected patient ...
Posted by Michael Wonder on 08 May 2018
FDA approves supplemental new drug application for Myrbetriq (mirabegron) for use in combination with solifenacin succinate for the treatment of overactive bladder symptoms
7 May 2018 - Astellas announced today that the U.S. FDA has approved a supplemental new drug application for the ...
Posted by Michael Wonder on 08 May 2018
Salix receives FDA approval for Plenvu, next generation 1 litre bowel cleansing preparation for colonoscopies
7 May 2018 - Salix Pharmaceuticals and its partner Norgine announced today that the U.S. FDA has approved Plenvu (polyethylene glycol ...
Posted by Michael Wonder on 08 May 2018
Genmab announces U.S. FDA approval of Darzalex (daratumumab) in newly diagnosed multiple myeloma
7 May 2018 - First approval for Darzalex in a frontline indication. ...
Posted by Michael Wonder on 07 May 2018
FDA grants priority review to Roche’s cancer immunotherapy Tecentriq (atezolizumab) for initial treatment of people with a specific type of metastatic lung cancer
7 May 2018 - Roche today announced that the US FDA has accepted the company’s supplemental biologics license application and granted ...
Posted by Michael Wonder on 06 May 2018
U.S. FDA approves Portola Pharmaceuticals’ Andexxa, first and only antidote for the reversal of factor Xa inhibitors
3 May 2018 - Breakthrough product is a major advance in the treatment of patients hospitalised with life-threatening bleeding. ...