FDA approval tracker: April

 Last month was loaded with US FDA knockbacks and delays. Reviews of four Jak inhibitors – abrocitinib, Xeljanz, Olumiant and Rinvoq – were pushed back until the third quarter, apparently on ongoing toxicity concerns with the class. Manufacturing inspection issues also rumbled on, resulting in a delay for Sol-Gel’s rosacea cream Epsolay and a CRL for Protalix’s Fabry candidate pegunigalsidase alfa. Meanwhile, the FDA’s adcom on accelerated approvals for anti-PD-(L)1 drugs gave positive votes for four of six indications discussed. The panel pushed back against Keytruda’s use in late-line gastric cancer and Opdivo’s in second-line liver cancer. Separately, Glaxosmithkline’s own anti-PD-L1 MAb Jemperli finally gained accelerated approved in second-line mismatch repair-deficient endometrial cancer, after a five-month delay caused by Covid-19 travel restrictions.

Notable first-time US approval decisions in April
Project	Company	2026e sales by indication ($m)	Outcome
Abrocitinib (PF-04965842)	Pfizer	1,127	Decision extended to early Q3
Zynlonta (loncastuximab tesirine)	ADC Therapeutics	1,025	Approved (accelerated) ~1 mth early
Jemperli (dostarlimab)	Glaxosmithkline	546	Approved (accelerated)
Eohilia (TAK-721)	Takeda	350	No decision yet
Oral sulopenem etzadroxil	Iterum	329	FDA needs more time to review filing, 2 Jun adcom postponed
IV Tramadol	Avenue	273	No decision yet
Qelbree (SPN-812)	Supernus	265	Approved
Tanezumab	Pfizer/Lilly	155	No decision yet
Epsolay	Sol-Gel	-	Delayed (manufacturing inspection)
Pegunigalsidase alfa	Protalix	-	CRL (manufacturing inspection)
Adtralza (tralokinumab)	Leo Pharma	-	CRL
Nextstellis (Estelle)	Mithra/Mayne Pharma Group	-	Approved
Teplizumab	Provention Bio	-	Deficiencies in filing, 27 May adcom
Source: Evaluate Pharma & company releases. https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-april-0