DemeRx Reports the US FDA IND Application Acceptance to Advance DMX-1001 for Alcohol Use Disorder

Shots: The US FDA has accepted IND application of DMX-1001 (oral noribogaine) for the treatment of alcohol use disorder (AUD) DemeRx completed a MAD trial of DMX-1001 in healthy volunteers, demonstrating safety, tolerability, & PK supportive of P-II in AUD. The company plans to initiate a P-II trial of DMX-1001 in AUD in 2027 Noribogaine…

ByRidhi Rastogi13 hours ago

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Regeneron and Sanofi Report the US FDA Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Shots: FDA has approved Dupixent to treat CSU pts (age 2-11yrs.), who were symptomatic despite H1 antihistamine treatment based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program, & P-III (CUPIDKids) trial Study A & C assessed Dupixent + SoC antihistamines (loading dose then 300mg Q2W; pts weighing <60kg received 200mg) vs PBO…

ByRidhi Rastogi14 hours ago

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Ipsen’s Ojemda (Tovorafenib) Receives Conditional Approval for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG) in the EU

Shots: The EC has granted conditional approval to Ipsen's Ojemda as a monotx. for the treatment of pts (≥6mos.) with pLGG harbouring a BRAF fusion or rearrangement or BRAF V600 mutation, who have progressed after ≥1 prior systemic therapy, across all 30 EEA states Approval was based on the P-II (FIREFLY-1) trial assessing Ojemda (QW, PO)…

ByRidhi Rastogi2 days ago

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Merck Reports the US FDA Approval of Idvynso for Virologically Suppressed HIV-1 Infection

Shots: The US FDA approved MSD's Idvynso (100mg doravirine/0.25mg islatravir; QD, PO) to treat HIV-1 in virologically suppressed adults (HIV-1 RNA <50 copies/mL) as a switch option for those on stable regimens with no prior treatment failure or doravirine resistance Approval was supported by the P-III trials, incl. Trial 052 (n=513), where pts switched from…

ByRidhi Rastogi2 days ago

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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 Rastogi3 days ago

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LEO Pharma’s Enstilar Receives the NMPA Approval for Plaque Psoriasis

Shots: The NMPA has approved Enstilar (calcipotriene/betamethasone dipropionate) for the treatment of adult patients with plaque psoriasis in China. Following NMPA approval, Enstilar is planned to launch in China later this year NMPA approval was backed by a P-III trial (n=604) in Chinese adults with plaque psoriasis, where QD Enstilar showed superior efficacy and met…

ByDipanshu DixitApril 17, 2026

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Bavarian Nordic Reports Swissmedic’s Approval of Vimkunya to Prevent Chikungunya

Shots: Swissmedic has approved Vimkunya (recombinant, adsorbed) for active immunization against CHIKV disease in individuals (≥12yrs.) Vimkunya is a single-dose, prefilled VLP-based chikungunya vaccine for individuals ≥12 years, designed to trigger rapid immunity with responses starting as early as 1 week Bavarian Nordic has submitted a Health Canada application, with potential chikungunya vaccine approval in…

ByDipanshu DixitApril 17, 2026

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LEO Pharma Reports the US FDA’s sNDA Acceptance of Anzupgo for Use in Children with Chronic Hand Eczema

Shots: The US FDA has accepted LEO Pharma's sNDA for Anzupgo(delgocitinib) cream for the treatment of pediatric patients (12-17yrs.) with mod. to sev. chronic hand eczema (CHE); regulatory review is ongoing in the EU sNDA was backed by the P-III (DELTA TEEN) trial assessing Anzupgo (20mg/g, BID) vs cream vehicle in pediatric pts with CHE…

ByRidhi RastogiApril 16, 2026

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AOP Health Reports the US FDA Approval Rapiblyk (Landiolol) for Pediatric Patients with Supraventricular Tachycardia

Shots: The US FDA has approved Rapiblyk (landiolol) for use in pediatric pts (from birth to <18 years of age) with supraventricular tachycardia (SVT), expanding its use beyond adults Approval was supported by the LANDI-PED study (n=60), which showed >20% reduction in ventricular rate, demonstrating clinically meaningful heart rate control in this patient subgroup Rapiblyk…

ByRidhi RastogiApril 16, 2026

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ARS Pharmaceuticals Reports Health Canada Approval of neffy 2mg to Treat Type I Allergic Reactions

Shots: Health Canada has approved ARS Pharma's neffy 2mg (adrenaline nasal spray) to treat allergic reactions (anaphylaxis) in adults & children (>30kg) In Nov 2024, ARS Pharma granted ALK exclusive rights to commercialize neffy outside the US, incl. EU, Canada, UK, & select markets in exchange for $155M in upfront & milestones till date, ~$310M…

ByRidhi RastogiApril 15, 2026

DemeRx Reports the US FDA IND Application Acceptance to Advance DMX-1001 for Alcohol Use Disorder

Regeneron and Sanofi Report the US FDA Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Ipsen’s Ojemda (Tovorafenib) Receives Conditional Approval for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG) in the EU

Merck Reports the US FDA Approval of Idvynso for Virologically Suppressed HIV-1 Infection

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

LEO Pharma’s Enstilar Receives the NMPA Approval for Plaque Psoriasis

Bavarian Nordic Reports Swissmedic’s Approval of Vimkunya to Prevent Chikungunya

LEO Pharma Reports the US FDA’s sNDA Acceptance of Anzupgo for Use in Children with Chronic Hand Eczema

AOP Health Reports the US FDA Approval Rapiblyk (Landiolol) for Pediatric Patients with Supraventricular Tachycardia

ARS Pharmaceuticals Reports Health Canada Approval of neffy 2mg to Treat Type I Allergic Reactions

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