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1 week ago | 
insights.citeline.com | Bridget Silverman
US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody. Sponsors have a lot hanging on upcoming user fee goal dates. (Shutterstock)
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1 week ago | 
insights.citeline.com | Bridget Silverman
EU Authorization Before US? Biologics Manufacturing Is Likely To Blame In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found. Most new products are approved in the US before the European Union, but those authorized in Europe first mostly are biologics. (Shutterstock)
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2 weeks ago | 
insights.citeline.com | Bridget Silverman
Pfizer’s All-Comers CRPC Dream For Talzenna Quashed For Lack Of Biomarker-Negative Rigor The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.
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2 weeks ago | 
insights.citeline.com | Bridget Silverman
Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma. J&J hopes to lead Darzalex Faspro to the first FDA-approved indication for smoldering multiple myeloma. (Shutterstock)
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2 weeks ago | 
insights.citeline.com | Bridget Silverman
Biomarker Negativity At Issue In Pfizer Bid To Broaden Talzenna CRPC Claim The FDA questioned Pfizer’s reliance on a “a large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.
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3 weeks ago | 
insights.citeline.com | Bridget Silverman
Smoldering Myeloma Endpoint Questions Carry J&J’s Darzalex Faspro To US FDA AdComm The US FDA seeks advice on the clinical meaningfulness of the endpoints of J&J’s AQUILA trial in smoldering multiple myeloma, highlighting the pitfalls of being the first candidate for the precancerous condition. US FDA questions about trial endpoints could dampen J&J's hopes for the first smoldering myeloma indication. (Shutterstock)
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4 weeks 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)
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1 month 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)
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1 month 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)
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1 month 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)
