BioCryst Pharmaceuticals Reports MHLW Approval of Orladeyo for Hereditary Angioedema

Shots: The MHLW has approved Orladeyo (berotralstat) for prophylactic therapy in pediatric pts (2 to <12 yrs.) with hereditary angioedema (HAE) Approval was based on interim APeX-P trial results in pediatric pts with HAE, which showed early & sustained reductions in monthly attack rates; published in the Annals of Allergy, Asthma & Immunology BioCryst plans to launch…

ByRidhi RastogiAugust 26, 2026

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Haisco Licenses Preclinical Immunology Drug to Sentivera in $1.5B+ Deal

Shots: Haisco has entered into an exclusive licensing agreement with Sentivera to develop, manufacture, & commercialize one of its preclinical immunology assets globally, excl. Greater China, in a deal valued at more than $1.5 billion. The agreement incl. $75.89M in upfront payment & equity consideration, ~$1.46B in development, regulatory & commercial milestones, plus tiered royalties…

ByRidhi RastogiAugust 26, 2026

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United Therapeutics Reports the US FDA NDA Acceptance for Ralinepag to Treat Pulmonary Arterial Hypertension

Shots: The US FDA has accepted the NDA for ralinepag to treat pulmonary arterial hypertension, with PDUFA target action date of Jun 24, 2027 NDA was supported by the P-III (ADVANCE OUTCOMES) trial assessing ralinepag vs PBO in 687 patients with PAH, where pts who completed the trial had the option to enroll in ongoing…

ByRidhi RastogiAugust 25, 2026

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Rhythm Pharmaceuticals’ Imcivree Secures MHLW Approval for Acquired Hypothalamic Obesity

Shots: The MHLW has approved Imcivree (setmelanotide) for pts (≥4yrs.) with acquired hypothalamic obesity (HO); commercial launch is expected by end of 2026, pending final pricing determination Approval was backed by the P-III (TRANSCEND) trial assessing Imcivree in 142 pts with acquired HO, incl. Japanese (n=12) & supplemental pts (n=10), which met its 1EP with…

ByRidhi RastogiAugust 25, 2026

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Tempus AI Secures FDA Clearance for AI-Enabled Pulmonary Hypertension ECG Tool

Shots: Tempus AI has received FDA 510(k) clearance for Tempus ECG-PH, an AI-enabled software device that analyzes standard 12-lead ECGs for signs associated with pulmonary hypertension (PH) Designed for patients aged 40 and older with cardiovascular symptoms but no known PH history, Tempus ECG-PH identifies ECG patterns associated with elevated mean pulmonary artery pressure Tempus…

ByRidhi RastogiAugust 25, 2026

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Celltrion Reports Launch of Omlyclo 300mg (Biosimilar, Xolair) in Europe

Shots: Celltrion has reported the launch of Omlyclo (300mg in PFS & autoinjector), a biosimilar version of Xolair (omalizumab), for the treatment of pts with allergic asthma & chronic spontaneous urticaria (CSU) in Europe Following the EU launch of Omlyclo 75mg & 150mg last year, Celltrion began rolling out the 300mg dose in Germany, the…

ByRidhi RastogiAugust 25, 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

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Roche’ Elecsys pTau217 Test Receives the US FDA Clearance to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Shots: The US FDA has granted clearance to Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology in people (≥55yrs.) with signs or complaints of cognitive decline In adults aged 55+ with cognitive decline associated with Alzheimer’s disease, Elecsys pTau217 showed high agreement with…

ByRidhi RastogiAugust 24, 2026

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Takeda Reports MHLW Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1

Shots: The MHLW has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults Approval was based on extensive data, incl. P-III (FirstLight & RadiantLight) trial assessing Orzeyful (BID) in NT1 pts over 12wks, where FirstLight randomized 168 pts to 3 arms (2mg, 1mg & PBO) & RadiantLight randomized…

ByRidhi RastogiAugust 24, 2026

Ridhi Rastogi

BioCryst Pharmaceuticals Reports MHLW Approval of Orladeyo for Hereditary Angioedema

Haisco Licenses Preclinical Immunology Drug to Sentivera in $1.5B+ Deal

United Therapeutics Reports the US FDA NDA Acceptance for Ralinepag to Treat Pulmonary Arterial Hypertension

Rhythm Pharmaceuticals’ Imcivree Secures MHLW Approval for Acquired Hypothalamic Obesity

Tempus AI Secures FDA Clearance for AI-Enabled Pulmonary Hypertension ECG Tool

Celltrion Reports Launch of Omlyclo 300mg (Biosimilar, Xolair) in Europe

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)

Roche’ Elecsys pTau217 Test Receives the US FDA Clearance to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Takeda Reports MHLW Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1

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