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Product Reviews & Approvals

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Approvals

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Latest From Approvals

Amgen Migraine Antibody, Bayer Oncologic, Spark Gene Therapy Join NME Review Queue

US FDA received several applications for new molecular entities last week, including a BLA for Alphaeon's Botulinum toxin that came just three years after number trails began.

Approvals Drug Review

Kalydeco Expands Indication Without Clinical Data; Keytruda Is Latest Bladder Cancer Approval

Keeping track of US FDA approvals last week included watching the creative and the familiar.

Approvals Review Pathway

All Set For EU Approval: First Biosimilar Humalog And Three More Rituximabs From Celltrion

The European Medicines Agency has given the thumbs-up to Insulin lispro Sanofi, the first biosimilar version of Lilly’s diabetes drug Humalog. It has also green-lighted three more biosimilar rituximab products from Celltrion, which already has EU approval for one version of the originator product, Roche’s MabThera.

Biosimilars Approvals

FDA's NDA And BLA Approvals: Jadenu Sprinkle

Original new drugs and biologics recently approved by US FDA.

Approvals Regulation

On The Rise In The EU: New Drug Applications, Conditional Approval Recommendations

Applications to the European Medicines Agency are continuing to rise, with orphan drugs playing a part in the increase, but the numbers of drugs for new pediatric indications and those for use outside the EU are still lamentably low. For the first time in five years, the CHMP issued no negative opinions, but more applications for accelerated assessment were rejected than accepted.

Approvals Drug Review

Keeping Track: Immuno-Oncology Racks Up More Approvals; Bar Still Too High For Advair Generics

The latest drug development news and highlights from our US FDA Performance Tracker.

Approvals Complete Response Letters
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Drug Reviews

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AB Science Asks For Re-examination After EMA Rejects Masitinib For Mastocytosis

The EMA’s main scientific committee, the CHMP, has rejected AB Science’s potential mastocytosis drug masitinib, but the company has asked for a re-examination of the decision on a number of grounds, including the fact that it has implemented GCP corrective actions and that updated information shows the product to have “acceptable” long-term safety.

Drug Review Compliance

Amgen Migraine Antibody, Bayer Oncologic, Spark Gene Therapy Join NME Review Queue

US FDA received several applications for new molecular entities last week, including a BLA for Alphaeon's Botulinum toxin that came just three years after number trails began.

Approvals Drug Review

Accelerated Assessment Decision ‘Imminent’ For Two Products In EMA’s PRIME Scheme

The sponsors of two products in the European Medicines Agency’s popular PRIME scheme for speeding patient access to drugs for unmet medical needs appear to be close to filing their applications for marketing authorization. Five more products were accepted on the scheme this week.

Europe Drug Review

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Regulation Advisory Committees

On The Rise In The EU: New Drug Applications, Conditional Approval Recommendations

Applications to the European Medicines Agency are continuing to rise, with orphan drugs playing a part in the increase, but the numbers of drugs for new pediatric indications and those for use outside the EU are still lamentably low. For the first time in five years, the CHMP issued no negative opinions, but more applications for accelerated assessment were rejected than accepted.

Approvals Drug Review

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Regulation Advisory Committees
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