Bridget Silverman

6 days ago | insights.citeline.com | Bridget Silverman

Keep Talking: US FDA’s Beleagured Biologics Center Remains Vital To Regenerative Medicine Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow. Regenerative medicine developers hope to flourish despite upheaval at US FDA. (Shutterstock)

1 week ago | insights.citeline.com | Sue Sutter |Bridget Silverman

FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation. The FDA will host three days of advisory committee meetings in mid-May. (Shutterstock)

2 weeks ago | insights.citeline.com | Bridget Silverman

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC BetThe 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD. Sponsors with upcoming user fee goal dates hope for a merry month of May. (Shutterstock)

3 weeks ago | insights.citeline.com | Bridget Silverman

Postmarketing Surprise Is Latest Plot Twist For Novavax’s COVID-19 Vaccine BLAThree weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said. After delays, Novavax hopes the FDA is signaling a path to approval for its COVID-19 vaccine. (Shutterstock)

3 weeks ago | insights.citeline.com | Bridget Silverman

US CDC ACIP Puts GSK’s Penmenvy Even With Pfizer, Prepares For Infant MedQuadFi, Lyme Vaccines US CDC’s Advisory Committee on Immunization Practices voted for harmonized meningococcal vaccine recommendations, while hearing updates about Sanofi’s pending supplemental MedQuadfi indication, AstraZeneca’s FluMist self-administration launch plans, and Lyme disease The Advisory Committee on Immunization Practices' April meeting was crowded with topics including both pentavalent and quadrivalent...