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Product Reviews & Approvals

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Approvals

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Latest From Approvals

Vaccines Boost Priority Profile Of US FDA’s Biologic Center 2019 Approvals

Tropical diseases were not neglected by the Center for Biologics Evaluation and Research in 2019, producing three novel vaccines (which earned three priority review vouchers) and tilting the approval class toward expedited review programs.

Vaccines Pink Sheet Perspectives

Postmarketing Trial For Horizon Thyroid Eye Drug Tepezza To Be Larger Than Expected

Horizon CEO says safety trial will be conducted in a larger patient population following discussions during the US FDA advisory committee meeting.

Post Market Regulation & Studies Approvals

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

Drug Review Europe

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with seven new products including Roche's Polivy for treating diffuse large B-cell lymphoma. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).

Approvals Europe

Neuroscience Challenges Oncology For Top Spot In CDER’s 2019 Novel Approvals

Oncology R&D isn’t waning, but investment in neurology and psychiatry drug development are paying off in new drug approvals. Rapid growth in CDER non-malignant hematology approvals reflects longer, broader trend toward orphan drugs.

Review Pathway Pink Sheet Perspectives

ViiV Wins Fast-Track Review At EMA For HIV Therapy

A number of new products have been submitted for review at the European Medicines Agency. While marketing authorization applications from ViiV Healthcare and BioMarin Pharmaceutical are being fast-tracked, a submission from Incyte is not.

Europe Approvals
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Drug Reviews

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Latest From Drug Review

Vaccines Boost Priority Profile Of US FDA’s Biologic Center 2019 Approvals

Tropical diseases were not neglected by the Center for Biologics Evaluation and Research in 2019, producing three novel vaccines (which earned three priority review vouchers) and tilting the approval class toward expedited review programs.

Vaccines Pink Sheet Perspectives

US FDA ‘Public Health’ Approach To Opioids May Open Up Pricing Debates

Latest effort by FDA to re-set reviews for novel opioid analgesics is off to a rocky start after three advisory committee reviews. One unintended consequences may already be apparent: by taking a broad, public health perspective on new formulations, the agency may be inviting arguments based on price.

Neurology Pricing Debate

Postmarketing Trial For Horizon Thyroid Eye Drug Tepezza To Be Larger Than Expected

Horizon CEO says safety trial will be conducted in a larger patient population following discussions during the US FDA advisory committee meeting.

Post Market Regulation & Studies Approvals

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

Drug Review Europe

Neuroscience Challenges Oncology For Top Spot In CDER’s 2019 Novel Approvals

Oncology R&D isn’t waning, but investment in neurology and psychiatry drug development are paying off in new drug approvals. Rapid growth in CDER non-malignant hematology approvals reflects longer, broader trend toward orphan drugs.

Review Pathway Pink Sheet Perspectives

Keeping Track: Nektar Withdraws Oxycodegol NDA As Novel Submission Pileup Continues

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

US FDA Performance Tracker Drug Review
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