BridgeBio Pharma Reports the US FDA Priority Review of Oral Infigratinib for Children with Achondroplasia

Shots: The US FDA has accepted NDA & granted Priority Review to infigratinib (PO) for the treatment of children with achondroplasia (PDUFA: Feb 4, 2027). BridgeBio is prepared to launch infigratinib upon approval Trial met its 1EP, with infigratinib improving annualized height velocity at Wk. 52 (mean treatment difference: +2.10cm/yr.) & its key 2EP of…

ByRidhi Rastogi2 days ago

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Roche Secures US FDA Priority Review for Fenebrutinib in both Relapsing and Primary Progressive Multiple Sclerosis

Shots: The US FDA has accepted an NDA & granted priority review to fenebrutinib for RMS & PPMS based on P-III (FENhance 1 & 2) studies & the P-III (FENtrepid) trial, respectively FENhance 1 & 2 showed fenebrutinib reduced relapses and active & chronic brain lesions vs teriflunomide, lowering ARR by 51.1% & 58.5%, respectively,…

ByRidhi RastogiOctober 1, 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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The US FDA Grants Priority Review to Takeda’s Zasocitinib in Plaque Psoriasis

Shots: The US FDA has accepted the NDA & granted priority review to zasocitinib (TAK-279) for the treatment of adults with mod. to sev. plaque psoriasis (PsO), with the PDUFA target action date in Q1’27. MAA is under EMA’s review, with further global filings planned NDA was supported by extensive data incl. global P-III (Latitude…

ByRidhi RastogiSeptember 14, 2026

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Genentech Secures the US FDA Priority Review for Enspryng (Satralizumab) to Treat MOGAD

Shots: FDA has granted Priority Review to the sBLA of Enspryng for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), with a PDUFA target action date set for Jan 10, 2027. Filing is also under EMA’s review, with a decision expected in Q3’27 sBLA was supported by the P-III (METEOROID) trial data, assessing Enspryng(60,…

ByRidhi RastogiSeptember 10, 2026

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AstraZeneca Reports P-III OBERON and TITANIA Results for Tozorakimab in COPD at ERS’26

Shots: AstraZeneca reported full results from the P-III OBERON and TITANIA studies, showing that tozorakimab 300 mg Q4W reduced moderate-to-severe COPD exacerbations versus PBO in pts. receiving inhaled standard of care In the primary population of former smokers, tozorakimab reduced exacerbations by 29% in OBERON and 34% in TITANIA, while reductions in the overall population…

ByPrince GiriSeptember 8, 2026

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Ionis’ Zanvastro (Zilganersen) Receives US FDA Approval for Alexander Disease (AxD)

Shots: FDA has approved Zanvastro (50mg, Q3M, intrathecal injection) for the treatment of AxD in pediatric & adult pts, with launch expected in the coming wks. FDA also granted Ionis a Rare Pediatric Disease PRV Approval was backed by the Phase I-III trial assessing Zanvastro (25 or 50mg) vs control in 54 AxD pts (1.5-53yrs.) for…

ByRidhi RastogiSeptember 4, 2026

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The US FDA Approves ViiV Healthcare’s Tivicay PD for Young Children with HIV-1

Shots: The US FDA has approved Tivicay PD (dolutegravir) in combination with other antiretrovirals for HIV-1 treatment in pediatric pts weighing ≥2kg, incl. treatment-naïve or experienced pts who have not previously received an INSTI The FDA decision follows Priority Review & is supported by data from the NIH-funded IMPAACT 2023 study & pediatric PK modeling.…

ByRidhi RastogiAugust 28, 2026

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GSK’s Jemperli (Dostarlimab) Secures US FDA Priority Review for dMMR/MSI-H Locally Advanced Rectal Cancer

Shots: The US FDA has accepted the sBLA under Project Orbis & granted priority review to Jemperli in previously untreated stage II/III dMMR/MSI-H locally advanced rectal cancer (PDUFA: Feb 2027), with eligibility for an earlier decision through the NPV program sBLA was based on the global P-II (AZUR-1) trial assessing Jemperli (dostarlimab) monotx. (500mg, IV, Q3W…

ByRidhi RastogiAugust 25, 2026

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J&J Reports US FDA Approval of Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

Shots: The US FDA has approved Imaavy (nipocalimab-aahu) for the treatment of wAIHA in pts (≥12yrs.) currently or previously treated with corticosteroids Approval was based on the P-II/III (ENERGY) trial, which assessed 2 different dose schedules of Imaavy vs PBO in 115 adults living with wAIHA for 24wks. followed by an OLE period, where pts…

ByRidhi RastogiAugust 25, 2026

BridgeBio Pharma Reports the US FDA Priority Review of Oral Infigratinib for Children with Achondroplasia

Roche Secures US FDA Priority Review for Fenebrutinib in both Relapsing and Primary Progressive Multiple Sclerosis

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

The US FDA Grants Priority Review to Takeda’s Zasocitinib in Plaque Psoriasis

Genentech Secures the US FDA Priority Review for Enspryng (Satralizumab) to Treat MOGAD

AstraZeneca Reports P-III OBERON and TITANIA Results for Tozorakimab in COPD at ERS’26

Ionis’ Zanvastro (Zilganersen) Receives US FDA Approval for Alexander Disease (AxD)

The US FDA Approves ViiV Healthcare’s Tivicay PD for Young Children with HIV-1

GSK’s Jemperli (Dostarlimab) Secures US FDA Priority Review for dMMR/MSI-H Locally Advanced Rectal Cancer

J&J Reports US FDA Approval of Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

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