Infographic guide to the almost 40 indications for burgeoning PD-1/L1 checkpoint inhibitor class either approved or under review, from the Pink Sheet's FDA Performance Tracker.
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Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.
A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
The UK drug regulator and England’s health technology assessment agency have joined forces under an information sharing agreement, aimed at accelerating patient access to newly approved medicines by three to six months.
