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RSS FeedPosted 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 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 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 03 May 2016
Allergan launches first generic version of Crestor (rosuvastatin calcium)
2 May 2016 - Allergan today confirmed that it has received final approval from the U.S. FDA on its abbreviated new ...
Posted by Michael Wonder on 02 May 2016
FDA approves Bayer's Gadavist (gadobutrol) injection as first contrast agent for use with magnetic resonance angiography of supra-aortic arteries
29 April 2016 - Bayer announced today that the U.S. FDA has approved Gadavist (gadobutrol) injection for use with magnetic resonance ...
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
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
FDA approves first generic Crestor
29 April 2016 - The U.S. FDA today approved the first generic version of Crestor (rosuvastatin calcium). ...
Posted by Michael Wonder on 29 Apr 2016
Therabron Therapeutics receives FDA fast track designation for rhCC10 for the prevention of chronic lung disease related to premature birth
28 April 2016 - Therabron Therapeutics announced today that it has received Fast Track Designation from the U.S. FDA for ...
Posted by Michael Wonder on 29 Apr 2016
FDA grants Advaxis fast track designation for ADXS-HER2 for patients with newly-diagnosed, non-metastatic osteosarcoma
28 April 2016 - Advaxis today announced that the FDA has granted Fast Track Designation for the company’s immunotherapy product candidate ...
Posted by Michael Wonder on 27 Apr 2016
FDA issues complete response letter for digital medicine new drug application
26 April 2016 - Otsuka and Proteus Digital Health today announced that the US FDA has issued a complete response letter ...
Posted by Michael Wonder on 27 Apr 2016
Novartis receives three FDA breakthrough therapy designations for Ilaris to treat rare types of periodic fever syndromes
27 April 2016 - Novartis announced today that the US FDA has granted three breakthrough therapy designations for Ilaris (canakinumab) to ...
Posted by Michael Wonder on 26 Apr 2016
Bristol-Myers Squibb’s Opdivo (nivolumab) receives breakthrough therapy designation from U.S. FDA for previously treated recurrent or metastatic squamous cell carcinoma of the head and neck
25 April 2016 - Bristol-Myers Squibb Company announced today that the FDA has granted breakthrough therapy designation to Opdivo for the ...
Posted by Michael Wonder on 26 Apr 2016
AbbVie receives FDA approval of supplemental new drug application for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin in genotype 1b chronic hepatitis C patients with compensated cirrhosis
25 April 2016 - AbbVie today announced that the FDA has approved a supplemental new drug application for the use of ...