ProVerum Receives the US FDA Approval for ProVee System to Treat Benign Prostatic Hyperplasia

Shots: The US FDA has approved ProVee System for the treatment of benign prostatic hyperplasia (BPH) Approval was backed by the ProVIDE study assessing ProVee in men, which met its 1 & 2EPs, showing significant & durable symptom relief as well as improved urinary flow through 12mos. compared to sham, with preserved sexual function &…

ByRidhi RastogiDecember 10, 2025

INSIGHTS+

The US FDA New Drug Approvals in November 2025

Shots: Innovation surged in November, with cutting-edge science and strategic collaborations reshaping the drug development landscape across oncology, renal disease, hereditary conditions, and more The US FDA cleared five standout therapies, including Bayer’s Hyrnuo (Sevabertinib), UCB’s Kygevvi (Doxecitine + Doxribtimine), and Arrowhead’s Redemplo, underscoring a month of meaningful clinical progress November 2025 closed with five approvals, matching last year’s total, signaling sustained momentum and a steady…

ByDipanshu DixitDecember 9, 2025

NEWS

Hope Medicine’s HMI-115 Receives the US FDA Fast Track Designation for Endometriosis-Associated Pain Relief

Shots: The US FDA has granted FTD to HMI-115 for the treatment of mod. to sev. pain associated with endometriosis Designation was based on the global P-II dose-finding study assessing HMI-115 vs PBO for 12wks. in 108 females with surgically diagnosed endometriosis across the US, Poland & China, showing significant improvement Trial showed that HMI-115…

ByRidhi RastogiDecember 5, 2025

NEWS

BMS Reports the US FDA Approval of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

Shots: The US FDA has approved Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with r/r MZL who have received ≥2L of systemic therapy Approval was supported by MZL cohort data from the P-II (TRANSCEND FL) trial assessing Breyanzi in pts with r/r indolent B-cell non-Hodgkin lymphoma incl. follicular lymphoma & MZL In…

ByRidhi RastogiDecember 5, 2025

NEWS

Merck Animal Health’s Exzolt Cattle-CA1 Receives the US FDA Conditional Approval Against New World Screwworm and Cattle Fever Tick

Shots: The US FDA has granted conditional approval to Exzolt Cattle-CA1 to prevent & treat New World screwworm (Cochliomyia hominivorax) larvae (myiasis) & cattle fever tick (Rhipicephalus microplus) Exzolt Cattle-CA1, a systemic fluralaner pour-on available in 1L & 5L presentations, is approved for use in beef cattle (≥2mos.) & replacement dairy heifers (<20mos.), with US availability…

ByRidhi RastogiDecember 5, 2025

NEWS

Capricor Therapeutics Reports the Topline P-III (HOPE-3) Trial Data on Deramiocel for Duchenne Muscular Dystrophy

Shots: Capricor Therapeutics has reported the topline P-III (HOPE-3) trial data assessing Deramiocel (IV, Q3M) vs PBO in boys & young men (n=106) with DMD for 12mos. across the US Trial met its 1EP with a 54% slowing of upper-limb functional decline (PUL v2.0) among 105 evaluable pts at 12mos. & achieved its 2EP with…

ByRidhi RastogiDecember 4, 2025

NEWS

Eli Lilly’s Jaypirca Receives the FDA Approval for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Shots: The US FDA has approved label expansion of Jaypirca (pirtobrutinib; 100 & 50mg) for the treatment of adults with r/r CLL/SLL who were previously treated with a covalent BTK inhibitor & converted the accelerated approval of Dec 2023 to a full approval Label expansion was based on the P-III (BRUIN CLL-321) study assessing Jaypirca…

ByRidhi RastogiDecember 4, 2025

NEWS

Formosa Pharmaceuticals Collaborates with Rxilient to Commercialize APP13007 Across ASEAN Markets

Shots: Formosa has entered into an exclusive licensing agreement with Rxilient to commercialize APP13007, a 0.05% clobetasol propionate ophthalmic suspension for the treatment of inflammation & pain after ocular surgery As per the deal, Rxilient will gain exclusive rights to commercialize the suspension across key ASEAN markets, incl. Indonesia, Philippines, Singapore, & Thailand, with the deal…

ByRidhi RastogiDecember 3, 2025

NEWS

Imvax Reports P-IIb Trial Findings on IGV-001 to Treat Newly Diagnosed Glioblastoma

Shots: Imvax has reported the topline data from the P-IIb trial assessing IGV-001 vs PBO in 99 pts with newly diagnosed glioblastoma (ndGBM) Trial showed an mOS of 20.3 vs 14mos., with an mFU of 22mos. for all pts, plus IGV-001 demonstrated measurable patient benefit across various metrics; safety was consistent with previous studies Additionally,…

ByRidhi RastogiDecember 3, 2025

NEWS

Ionis’ Zilganersen Receives the US FDA’s Breakthrough Therapy Designation for Alexander Disease

Shots: The US FDA has granted BTD to zilganersen for the treatment of Alexander disease (AxD) Designation was supported by the topline P-III trial data, which assessed zilganersen (25 or 50mg) vs control in 54 AxD pts (1.5-53yrs.). Zilganersen (50mg) met the 1EP of gait speed as assessed by 10-Meter Walk Test at 61wks., plus…

ByRidhi RastogiDecember 3, 2025

ProVerum Receives the US FDA Approval for ProVee System to Treat Benign Prostatic Hyperplasia

The US FDA New Drug Approvals in November 2025

Hope Medicine’s HMI-115 Receives the US FDA Fast Track Designation for Endometriosis-Associated Pain Relief

BMS Reports the US FDA Approval of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

Merck Animal Health’s Exzolt Cattle-CA1 Receives the US FDA Conditional Approval Against New World Screwworm and Cattle Fever Tick

Capricor Therapeutics Reports the Topline P-III (HOPE-3) Trial Data on Deramiocel for Duchenne Muscular Dystrophy

Eli Lilly’s Jaypirca Receives the FDA Approval for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Formosa Pharmaceuticals Collaborates with Rxilient to Commercialize APP13007 Across ASEAN Markets

Imvax Reports P-IIb Trial Findings on IGV-001 to Treat Newly Diagnosed Glioblastoma

Ionis’ Zilganersen Receives the US FDA’s Breakthrough Therapy Designation for Alexander Disease

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