QIAGEN Receives the US FDA Clearance for QIAstat-Dx BCID GN Plus AMR Panel

Shots: The US FDA has granted clearance to the QIAstat-Dx BCID GN Plus AMR Panel, completing QIAGEN’s US bloodstream infection testing portfolio with coverage of gram-negative bacteria & antimicrobial resistance markers The new panel can detect 13 gram-negative bacterial targets & 18 AMR markers from positive blood cultures in about one hour, complementing the previously…

ByRidhi RastogiSeptember 28, 2026

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AstraZeneca Secures US FDA Priority Review for Imfinzi + Enfortumab Vedotin for Muscle-Invasive Bladder Cancer

Shots: The US FDA has accepted sBLA and granted Priority Review to Imfinzi (durvalumab) + enfortumab vedotin (EV) for the treatment of pts with MIBC who are ineligible for or have declined cisplatin-based CT (PDUFA: Q4’26). Regulatory review is ongoing in EU & Japan sBLA was based on the P-III (VOLGA) trial, which randomized 695…

ByRidhi RastogiSeptember 28, 2026

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Mirum and Incyte Report FDA Approval of Atebrioz (Zilurgisertib) for Fibrodysplasia Ossificans Progressiva

Shots: The US FDA has approved Atebrioz (100mg, PO, QD) tablets to reduce the volume of total new heterotopic ossification (HO) in pts (≥12yrs.) with FOP, & issued a Rare Pediatric Disease PRV to Incyte. MAA is under EMA’s review Approval was based on Cohort 1 of the P-II (PROGRESS) study, where at Wk. 24,…

ByRidhi RastogiSeptember 28, 2026

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Eli Lilly Reports the US FDA Approval for Olumiant to Treat Severe Alopecia Areata in Pediatric Patients

Shots: The US FDA has approved Olumiant (baricitinib) for the treatment of pediatric pts (≥12yrs.) with severe alopecia areata (AA), expanding its use from treating adults with mod. to sev. active rheumatoid arthritis & sev. AA Approval was based on 36wk. data from the adolescent cohort (12 to <18yrs.) of P-III (BRAVE-AA-PEDS) study assessing Olumiant…

ByRidhi RastogiSeptember 28, 2026

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Merck and Eisai Report US FDA Approval of Welireg + Lenvima in Advanced Renal Cell Carcinoma

Shots: The US FDA has approved Welireg + Lenvima for the treatment of adults with advanced renal cell carcinoma with a clear cell component (ccRCC) following a PD-1 or PD-L1 inhibitor Approval was based on the P-III (LITESPARK-011) trial assessing Welireg (120mg, PO, QD) + Lenvima (20mg, PO, QD) vs cabozantinib in 747 pts with advanced…

ByRidhi RastogiSeptember 25, 2026

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Eli Lilly Reports the US FDA Approval for Onswik to Treat Type 2 Diabetes

Shots: The US FDA has approved Onswik (insulin efsitora alfa-gobe) along with diet and exercise to control high blood sugar in adults with type 2 diabetes Approval was based on the P-III (QWINT) trials, which evaluated Onswik (QW) in >3,400 adults with T2D; across each trial, Onswik met the 1EP, demonstrating non-inferior A1C reductions vs…

ByRidhi RastogiSeptember 25, 2026

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NET Recovery Reports the US FDA Breakthrough Device Designation of NET Device for Stimulant Use Disorder

Shots: The US FDA has granted Breakthrough Device Designation for its NET Device as an aid in reducing psychostimulant use in adults diagnosed with stimulant use disorder, incl. cocaine use disorder & amphetamine-type/ methamphetamine use disorder NET Recovery is designing a pivotal randomized controlled trial intended to support FDA marketing authorization, which the company believes…

ByRidhi RastogiSeptember 24, 2026

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Elevar Therapeutics Secures the US FDA Approval for Lyrfigtu (Lirafugratinib) to Treat Cholangiocarcinoma

Shots: The US FDA has approved Lyrfigtu for the 2L treatment of cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement; US availability is expected by Q4’26 In the P-I/II (ReFocus) trial, Lyrfigtu showed a cORR of 46%, an mDoR of 11.8mos., & 12mos. PFS rate of 49.2% (mPFS: 11.3mos.), with a predictable and manageable safety…

ByRidhi RastogiSeptember 24, 2026

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Cordis’ Selution SLR Drug-Eluting Balloon Receives US FDA Approval for In-Stent Restenosis

Shots: The US FDA has approved the Selution SLR (Sustained Limus Release) Drug-Eluting Balloon (DEB) for the treatment of coronary in-stent restenosis (ISR) Approval was supported by data from the SELUTION4ISR trial assessing Selution SLR DEB vs SoC, incl. 80% drug-eluting stents, in pts (n >400) with coronary ISR across the US, Canada, Brazil, &…

ByRidhi RastogiSeptember 22, 2026

NEWS

Eli Lilly Receives Full FDA Approval for Inluriyo + Verzenio to Treat ESR1-mutated Breast Cancer

Shots: FDA has granted full approval to Inluriyo (imlunestrant; PO) + Verzenio (abemaciclib) for treating adults with ER+, HER2-, ESR1-mutated locally advanced or metastatic breast cancer whose disease progressed after ≥1L of endocrine therapy (ET) Approval was based on the P-III (EMBER-3) trial assessing Inluriyo ± Verzenio in ESR1-mutated MBC pts (n=159); Inluriyo + Verzenio (n=67) doubled the…

ByRidhi RastogiSeptember 21, 2026

QIAGEN Receives the US FDA Clearance for QIAstat-Dx BCID GN Plus AMR Panel

AstraZeneca Secures US FDA Priority Review for Imfinzi + Enfortumab Vedotin for Muscle-Invasive Bladder Cancer

Mirum and Incyte Report FDA Approval of Atebrioz (Zilurgisertib) for Fibrodysplasia Ossificans Progressiva

Eli Lilly Reports the US FDA Approval for Olumiant to Treat Severe Alopecia Areata in Pediatric Patients

Merck and Eisai Report US FDA Approval of Welireg + Lenvima in Advanced Renal Cell Carcinoma

Eli Lilly Reports the US FDA Approval for Onswik to Treat Type 2 Diabetes

NET Recovery Reports the US FDA Breakthrough Device Designation of NET Device for Stimulant Use Disorder

Elevar Therapeutics Secures the US FDA Approval for Lyrfigtu (Lirafugratinib) to Treat Cholangiocarcinoma

Cordis’ Selution SLR Drug-Eluting Balloon Receives US FDA Approval for In-Stent Restenosis

Eli Lilly Receives Full FDA Approval for Inluriyo + Verzenio to Treat ESR1-mutated Breast Cancer

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