Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Priority Review for 1L Treatment of HER2-Mutated NSCLC

Shots: The US FDA has granted Priority Review to Bayer’s Hyrnuo (sevabertinib) for the 1L treatment of adults with locally advanced or metastatic NSCLC harboring HER2 (ERBB2) TKD-activating mutations & no prior systemic therapy sNDA was supported by preliminary data from Cohort F of the P-I/II (SOHO-01) trial evaluating the efficacy & safety of Hyrnuo…

ByRidhi Rastogi2 days ago

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Pfizer Receives the EC Approval for Hympavzi to Treat Hemophilia A and B

Shots: The EC has approved Pfizer's Hympavzi (marstacimab; QW, SC) for the treatment of pts (≥12yrs., ≥35kg) with hemophilia A with FVIII inhibitors or hemophilia B with FIX inhibitors, based on P-III (BASIS) study During the active treatment period, Hympavzi achieved a 93% reduction in mean treated ABR vs on-demand therapy (1.39 vs 19.78), plus…

ByRidhi RastogiMay 13, 2026

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BeOne Receives the US FDA Priority Review to Tevimbra Combination for 1L Treatment of HER2+ GEA Cancers

Shots: FDA has granted priority review to BeOne's Tevimbra + Ziihera & CT for the 1L treatment of unresectable locally advanced/metastatic HER2+ gastric, GEJ, or esophageal adenocarcinoma; BeOne plans to participate in the FDA’s Project Orbis sBLA was based on the P-III (HERIZON-GEA-01) trial, which assessed Ziihera + CT ± Tevimbra vs Herceptin + CT as…

ByRidhi RastogiApril 30, 2026

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HUTCHMED Reports NMPA’s NDA Acceptance under Priority Review for Sovleplenib to Treat wAIHA

Shots: The Chinese NMPA has accepted NDA & granted priority review to HUTCHMED's sovleplenib for the treatment of adults with warm antibody autoimmune hemolytic anemia (wAIHA) who had an inadequate response to ≥1 previous glucocorticoid treatment NDA was supported by the Chinese P-II/III (ESLIM-02) assessing sovleplenib vs PBO in adults with primary or secondary wAIHA who had…

ByRidhi RastogiApril 29, 2026

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The US FDA Grants Priority Review and Breakthrough Therapy Designation to GSK’s Bepirovirsen for Chronic Hepatitis B

Shots: The US FDA has accepted NDA & granted priority review as well as BTD to GSK's bepirovirsen for the treatment of adults with chronic hepatitis B (CHB) NDA & designation were supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline…

ByRidhi RastogiApril 28, 2026

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Sanofi Reports the US FDA Approval of Tzield to Delay Onset of Stage 3 Type 1 Diabetes in Children (≥1years)

Shots: The US FDA has approved Sanofi's Tzield (teplizumab-mzwv), under priority review, to delay of the onset of stage 3 T1D in pts (≥1yr.) diagnosed with stage 2 T1D Approval was supported by 1yr. data from the ongoing P-IV (PETITE-T1D) trial assessing the safety & PK of Tzield (IV, QD for 14 consecutive days) in…

ByRidhi RastogiApril 22, 2026

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Astellas and Pfizer Gain FDA Priority Review for Padcev + Keytruda in Muscle-Invasive Bladder Cancer (MIBC), Regardless of Cisplatin Eligibility

Shots: The US FDA has accepted sBLA & granted priority review to perioperative Padcev + Keytruda/Keytruda Qlex for the treatment of pts with MIBC, regardless of cisplatin eligibility (PDUFA: Aug 17, 2026) sBLA was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs…

ByRidhi RastogiApril 21, 2026

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Daiichi Sankyo and Merck Receives FDA’s Priority Review for Ifinatamab Deruxtecan (I-DXd) to Treat ES-SCLC

Shots: FDA has accepted BLA for I-DXd under the RTOR & Project Orbis program, granting priority review for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed on or after Pt-based CT (PDUFA: Oct 10, 2026) BLA was based on the P-II (IDeate-Lung01) study assessing I-DXd (IV, Q3W) in…

ByRidhi RastogiApril 14, 2026

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The US FDA Grants Accelerated Approval Denali Therapeutics’ Avlayah (Tividenofusp alfa-eknm) for Hunter Syndrome (MPS II)

Shots: FDA has granted accelerated approval to Avlayah, an enzyme replacement therapy (ERT), for the treatment of presymptomatic or symptomatic MPS II pediatric pts (≥5kg), along with a RPD PRV to Denali; US availability is expected shortly Approval was based on the P-I/II trial of Avlayah (QW) in 47 pts, incl. ERT-naïve (n=15) & previously…

ByRidhi RastogiMarch 26, 2026

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Ionis’ Zilganersen Receives US FDA Priority Review for Alexander Disease

Shots: The US FDA has accepted NDA & granted priority review to zilganersen for the treatment of Alexander disease (AxD), with PDUFA target action date of Sep 22, 2026 NDA was backed by the P-III trial assessing zilganersen (25 or 50mg) vs control in 54 AxD pts (1.5-53yrs.) for 60wks., followed by an open label…

ByRidhi RastogiMarch 25, 2026

Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Priority Review for 1L Treatment of HER2-Mutated NSCLC

Pfizer Receives the EC Approval for Hympavzi to Treat Hemophilia A and B

BeOne Receives the US FDA Priority Review to Tevimbra Combination for 1L Treatment of HER2+ GEA Cancers

HUTCHMED Reports NMPA’s NDA Acceptance under Priority Review for Sovleplenib to Treat wAIHA

The US FDA Grants Priority Review and Breakthrough Therapy Designation to GSK’s Bepirovirsen for Chronic Hepatitis B

Sanofi Reports the US FDA Approval of Tzield to Delay Onset of Stage 3 Type 1 Diabetes in Children (≥1years)

Astellas and Pfizer Gain FDA Priority Review for Padcev + Keytruda in Muscle-Invasive Bladder Cancer (MIBC), Regardless of Cisplatin Eligibility

Daiichi Sankyo and Merck Receives FDA’s Priority Review for Ifinatamab Deruxtecan (I-DXd) to Treat ES-SCLC

The US FDA Grants Accelerated Approval Denali Therapeutics’ Avlayah (Tividenofusp alfa-eknm) for Hunter Syndrome (MPS II)

Ionis’ Zilganersen Receives US FDA Priority Review for Alexander Disease

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