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 Rastogi3 days ago

NEWS

BridgeBio Pharma Reports the US FDA’s NDA Acceptance for Encaleret to Treat Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Shots: The US FDA has accepted NDA for encaleret to treat ADH1, with a PDUFA date of May 8, 2027, & no advisory committee planned. BridgeBio is prepared for a potential launch, while an EU MAA filing is expected in H2’26 Encaleret was evaluated in the P-III (CALIBRATE) trial, which met its 1 & 2EPs,…

ByRidhi RastogiJuly 22, 2026

NEWS

BridgeBio Pharma’s Attruby (Acoramidis) Secures the US FDA’s Approval to Treat ATTR-CM

Shots: The US FDA has approved Attruby (oral stabilizer of Transthyretin) to reduce cardiovascular death & associated hospitalization in ATTR-CM patients. The MAA is also under review in the EU, with decision anticipated in 2025 Approval was based on P-III (ATTRibute-CM) study of Attruby vs PBO in ATTR-CM patients (n=632). It achieved its 1EP, showing…

ByDipanshu DixitNovember 22, 2024

INSIGHTS+

Insights+: Key Takeaways of J.P. Morgan Healthcare Conference 2023 Based on Therapeutic Areas

Shots: The 41st Annual J.P. Morgan Healthcare Conference took place on 09 – 12 January 2023 in San Francisco, CA, USA. It is the largest and most informative healthcare investment symposium in the industry, bringing together a cohort of industry leaders, emerging fast-growing companies, innovative technology creators, and members of the investment community The major announcement…

BySenior EditorJanuary 19, 2023

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in September 2022

The EMA approved 7 New Chemical Entity (NCE) and 4 Biologic Drugs in Sept 2022, leading to treatments for patients and advances in the healthcare industry In September 2022, the major highlights drugs were Imcivree approval for bardet-biedl syndrome, Opdualag for unresectable or metastatic melanoma, Ultomiris for generalised myasthenia gravis PharmaShots has compiled a list…

BySenior EditorOctober 26, 2022

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

BridgeBio Pharma Reports the US FDA’s NDA Acceptance for Encaleret to Treat Autosomal Dominant Hypocalcemia Type 1 (ADH1)

BridgeBio Pharma’s Attruby (Acoramidis) Secures the US FDA’s Approval to Treat ATTR-CM

Insights+: Key Takeaways of J.P. Morgan Healthcare Conference 2023 Based on Therapeutic Areas

Insights+: EMA Marketing Authorization of New Drugs in September 2022

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