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FDA says there is shortage of Mylan’s Epipen in US biospectrumasia
May 11, 2018
in Share .    Mylan NV's EpiPen products are in shortage due to manufacturing delays that are creating intermittent supply constraints of the emergency allergy treatment
FDA grants priority review to Roche's cancer immunotherapy TECENTRIQ (atezolizumab) for initial treatment of people with a specific type of metastatic lung cancer worldpharmanews
May 11, 2018
Roche announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for TECENTRIQ® (atezolizumab),
WuXi STA Changzhou site passes first FDA inspection cphi-online
May 10, 2018
STA Pharmaceutical's API R&D and manufacturing facility located in Changzhou, China has secured Pre-Approval Inspection (PAI) for two APIs from the US FDA
FDA places PaxVax's phase 2 Chikungunya shot on its 'fast track' fiercepharma
May 09, 2018
Working against a disease with no available vaccines, PaxVax has picked up an important regulatory boost from the FDA for its Chikungunya shot. The agency blessed the candidate with its Fast Track Designation...
WuXi STA receives PAI from the US FDA biospectrumasia
May 08, 2018
This is the first time that WuXi STA's Changzhou facility has been inspected by the FDA
Kindred Biosciences Receives FDA Approval of Mirataz biospectrumasia
May 08, 2018
Kindred Biosciences Receives FDA Approval of Mirataz™ (mirtazapine transdermal ointment) for the Management of Weight Loss in Cats
Portola's Andexxa bleeding antidote wins FDA nod but will see limited release fiercepharma
May 08, 2018
Portola has finally overcome FDA concerns to win approval of its coagulation factor Xa, a bleeding antidote for some of the new generation blood thinners like Xarelto and Eliquis. Portola will launch Andexxa next month, although initial supplies will be l
Roche's Tecentriq cocktail hops into the FDA fast lane for another Merck showdown fiercepharma
May 08, 2018
The company said Monday that the triplet won FDA priority review for previously untreated patients with advanced lung cancer, and that means it could go toe-to-toe with Merck & Co. by Sept. 5.
FDA delays decision on inotersen, handing lead to Alnylam fiercebiotech
May 07, 2018
The FDA has delayed the PDUFA date for Akcea’s hereditary TTR amyloidosis drug inotersen, handing first-mover advantage to Alnylam. Akcea suffered the setback after the FDA asked for more time to review its response to requests for information ...
FDA chief Gottlieb to pharma: Those rebates you love to hate may soon count as kickbacks fiercepharma
May 07, 2018
FDA Commissioner Scott Gottlieb, M.D., hasn’t been shy about allying with President Donald Trump on the subject of high drug prices. Even though pricing is not the FDA's purview, Gottlieb has vowed to do ...

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