The US FDA New Drug Approvals in June 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of June 2025 The US FDA has approved a total of 5 new drugs, including 2 new molecular entities and 3 biologics, leading to the treatment of patients and advances in the pharmaceutical industry The major highlighted drug was Daiichi Sankyo and AstraZeneca’s Datroway, securing…

ByDipanshu DixitJuly 15, 2025

NEWS

Sun Pharma Launches Leqselvi (Deuruxolitinib) to Treat Severe Alopecia Areata in the US

Shots: Sun Pharma has launched Leqselvi (deuruxolitinib; 8mg) for the treatment of pts with severe alopecia areata in the US FDA Approval was based on 2 P-III (THRIVE-AA1 & THRIVE-AA2) trials that assessed the scalp hair regrowth using the SALT score with Leqselvi (8 or 12mg, BID) vs PBO in adults (n=1223; 18-65yrs.) with severe alopecia areata…

ByDipanshu DixitJuly 15, 2025

NEWS

Merck Advances MK-8527 in P-III (EXPrESSIVE) Trials to Prevent HIV in Individuals at Risk

Shots: Merck has initiated P-III (EXPrESSIVE-11) trial to evaluate MK-8527 (QM) vs FTC/TDF for HIV PrEP in ~4,390 individuals at higher risk across 16 countries (enrolment from Aug 2025), & will begin the P-III (EXPrESSIVE-10) trial in ~4,580 women (16-30yrs.) in sub-Saharan Africa, with enrolment starting in the next few mos. Decision to initiate P-III…

ByDipanshu DixitJuly 15, 2025

NEWS

Ultragenyx Reports the Health Canada’s Approval of Evkeeza (evinacumab) to Treat Children with Homozygous Familial Hypercholesterolemia (HoFH)

Shots: Health Canada has approved label expansion of Evkeeza, as an adjunct to diet & other lipid-lowering therapies, to treat children (≥6mos.) with HoFH Approval was based on model-based analysis that predicted similar or greater LDL-C reductions with Evkeeza (15mg/kg, Q4W) in children (6mos. to 5yrs.) at 24wks. Data from compassionate use in 5 children…

ByDipanshu DixitJuly 15, 2025

NEWS

Eolas Therapeutics Joins Forces with AstraZeneca to Develop AZD4041

Shots: Eolas Therapeutics has secured full development rights from AstraZeneca for AZD4041 to treat opioid use disorder (OUD) and other substance use disorders; terms remain confidential As per the agreement, Eolas will take full responsibility for AZD4041 under the existing IND and advance it to P-II trials with NIDA UG3 support, focusing on a patient-centered…

ByDipanshu DixitJuly 11, 2025

NEWS

FDA Approves Merck Animal Health’s Bravecto Quantum to Treat and Protect Dogs from Fleas and Ticks

Shots: The US FDA has approved Bravecto Quantum (Fluralaner for Extended-Release Injectable Suspension), a once-yearly injectable for flea and tick protection in dogs, will be available in U.S. veterinary clinics by Aug, 2025 Bravecto Quantum kills adult fleas and controls flea and tick infestations (Ixodes scapularis, Dermacentor variabilis, Rhipicephalus sanguineus) for 12 mos., and Amblyomma…

ByDipanshu DixitJuly 11, 2025

NEWS

Merck NDA for Investigational HIV-1 Two-Drug Regimen DOR/ISL Accepted by US FDA

Shots: The US FDA accepted Merck’s NDA for once-daily oral doravirine/islatravir (DOR/ISL) for virologically suppressed HIV-1 adults; PDUFA target action date: Apr 28, 2026 DOR/ISL showed non-inferiority to bART in open-label P-III MK-8591A-051 and to BIC/FTC/TAF (50mg/200mg/25mg) in P-III MK-8591A-052 at Week 48; the safety profile was generally comparable in the P-III MK-8591A-051 study The…

ByDipanshu DixitJuly 11, 2025

NEWS

Moleculin Receives RAMPA’s CTA Approval for P-IIb/III (MIRACLE) Study of AnnAraC in R/R AML

Shots: Moleculin received approval from Georgia’s RAMPA to initiate its global P-IIb/III (MIRACLE) study of AnnAraC (Annamycin + cytarabine) in R/R AML, and first pt dosing expected by Aug-end; CTA already approved in EU The study includes adaptive design; Part A will randomize 75-90 pts (1:1:1) to HiDAC + PBO or Annamycin (190 or 230…

ByDipanshu DixitJuly 11, 2025

NEWS

AbbVie Enters a Licensing Deal with IGI Therapeutics for ISB 2001

Shots: AbbVie and IGI Therapeutics, a subsidiary of Ichnos Glenmark Innovation, have entered into an exclusive licensing deal for ISB 2001, a drug targeting oncology & autoimmune diseases developed using IGI's proprietary BEAT protein platform As per the deal, AbbVie will obtain exclusive rights to develop, manufacture, and commercialize ISB 2001 across North America, Europe,…

ByDipanshu DixitJuly 11, 2025

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LIFE SCIENCES | DAILY NEWS | JUL 10, 2025 | PHARMASHOTS

ByDipanshu DixitJuly 10, 2025

Dipanshu Dixit

The US FDA New Drug Approvals in June 2025

Sun Pharma Launches Leqselvi (Deuruxolitinib) to Treat Severe Alopecia Areata in the US

Merck Advances MK-8527 in P-III (EXPrESSIVE) Trials to Prevent HIV in Individuals at Risk

Ultragenyx Reports the Health Canada’s Approval of Evkeeza (evinacumab) to Treat Children with Homozygous Familial Hypercholesterolemia (HoFH)

Eolas Therapeutics Joins Forces with AstraZeneca to Develop AZD4041

FDA Approves Merck Animal Health’s Bravecto Quantum to Treat and Protect Dogs from Fleas and Ticks

Merck NDA for Investigational HIV-1 Two-Drug Regimen DOR/ISL Accepted by US FDA

Moleculin Receives RAMPA’s CTA Approval for P-IIb/III (MIRACLE) Study of AnnAraC in R/R AML

AbbVie Enters a Licensing Deal with IGI Therapeutics for ISB 2001

LIFE SCIENCES | DAILY NEWS | JUL 10, 2025 | PHARMASHOTS

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