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The FDA has approved Smart Immune’s investigational new drug (IND) application for ProTcell, a T cell progenitor-based biotherapy candidate, marking the first time the agency has cleared a product of its kind to enter clinical trials. Read More
The UK’s Medicines and Healthcare products Regulatory Agency has issued its first drug approval under Project Orbis, a joint program by the FDA, Canada, Australia, Switzerland, Singapore, Brazil and the UK for reviews of cancer treatments. Read More
The FDA has granted Merck priority reviews for its blockbuster cancer drug Keytruda (pembrolizumab) alongside Lenvima (lenvatinib) for endometrial and renal cell carcinoma. Read More
First to receive Emergency Use Authorization (EUA) for their highly effective COVID-19 vaccine, Pfizer and BioNTech have now become first to submit a biologics license application (BLA) with the FDA for full approval of their inoculation. Read More
The European Union approved Bavencio in January as a first-line maintenance treatment for adults with locally advanced or metastatic urothelial carcinoma who are progression-free after platinum-based chemotherapy. Read More
For a full approval, the FDA will require six months’ worth of supporting data, compared with just two months for an Emergency Use Authorization. Read More
In a phase 3 study, Benlysta plus standard therapy improved kidney response rates and prevented worsening of kidney functions vs. standard therapy alone. Read More
The FDA has issued a complete response letter (CRL) to LEO Pharma, requesting additional information regarding a device component for the Danish drugmaker’s moderate-to-severe atopic dermatitis candidate tralokinumab. Read More