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 Rastogi4 days ago

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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 Rastogi4 days ago

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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 Rastogi4 days ago

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Nanexa and Novo Ink ~ €1.165B Deal for Long-Acting Injectables

Shots: Nanexa has entered into a global exclusive license & collaboration agreement with Novo for the use of its PharmaShell ALD drug delivery technology platform, for certain peptide-based drugs targeting obesity, T2D & other cardiometabolic indications As per the deal, Novo will receive a global license to Nanexa’s PharmaShell platform for use in ~5 development programs,…

ByRidhi Rastogi4 days ago

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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 Rastogi4 days ago

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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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Neuraxpharm and Minoryx Report the EC Approval of Nezglyal for Cerebral Adrenoleukodystrophy (cALD)

Shots: EC has approved Nezglyal (leriglitazone) under exceptional circumstances for male cALD pts (2-12yrs.) with Gadolinium (Gd)-negative brain lesions, based on P-II/III (NEXUS) trial data & RWE data from compassionate use programs The first EU launch is expected in Germany by year-end, with additional launches anticipated following national reimbursement negotiations, while Neuraxpharm evaluates access pathways…

ByRidhi RastogiSeptember 25, 2026

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Merck Reports the P-IIb/III (BRUNELLO) Trial Data on Remigromig for Diabetic Macular Edema

Shots: Merck has reported the P-IIb/III (BRUNELLO) trial data assessing remigromig (MK-3000, formerly EYE103;0.5 & 0.8mg, IVT, Q4W) vs 0.5mg ranibizumab (Q4W) in 984 adults with diabetic macular edema (DME) At 52 wks., both remigromig doses demonstrated non-inferiority to 0.5mg ranibizumab in mean change from baseline in best-corrected visual acuity in pts with DME, with…

ByRidhi RastogiSeptember 25, 2026

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Amberstone and Henlius Partner to Develop Conditionally Activated T-Cell Engagers for Solid Tumors

Shots: Amberstone Biosciences has entered into a collaboration & license agreement with Henlius Biotech to advance conditionally activated T-cell engagers for the treatment of solid tumors As per the deal, Amberstone will use its T-MATE platform to generate preclinical candidates against ~2 Henlius-selected targets, while Henlius will lead subsequent research, development, manufacturing & global commercialization…

ByRidhi RastogiSeptember 25, 2026

Ridhi Rastogi

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

Nanexa and Novo Ink ~ €1.165B Deal for Long-Acting Injectables

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

Neuraxpharm and Minoryx Report the EC Approval of Nezglyal for Cerebral Adrenoleukodystrophy (cALD)

Merck Reports the P-IIb/III (BRUNELLO) Trial Data on Remigromig for Diabetic Macular Edema

Amberstone and Henlius Partner to Develop Conditionally Activated T-Cell Engagers for Solid Tumors

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