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Recent Articles

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Pfizer and BioNTech receive FDA fast track designation for single-dose mRNA-based vaccine candidate against COVID-19 and influenza

FDA expected to make decision on Pfizer RSV vaccine in May

FDA withdraws emergency use authorization of Eli Lilly’s bebtelovimab injectable COVID-19 antibody therapy, citing the therapy is most likely ineffective against Omicron BQ.1 and BQ.1.1; Lilly had supplied 60,000 doses of the drug to US government in Q3

FDA states 4 mg naloxone nasal spray and 2 mg intramuscular autoinjector delivery overdose reversal med formats may be approvable for OTC use; FDA singled out Kaleo’s Evzio prefilled autoinjector, Emergent BioSolutions' Narca nasal spray as candidates

AstraZeneca reports three new cancer drugs recommended for approval in EU; drugs include Imfinzi/chemotherapy combo treatment for biliary tract cancer, gastric cancer drug Enhertu, prostate cancer treatment Lynparza in combination with Abiraterone

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