The US FDA Approves Amgen’s Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis

Shots: The US FDA has approved Amgen's Uplizna for the treatment of AChR & MuSK antibody positive adults with generalized myasthenia gravis (gMG) Approval was based on P-III (MINT) trial in 238 adults with gMG (190 AChR+, 48 MuSK+), where pts received 2 Uplizna loading dose followed by 2 doses/year; pts on steroids began tapering…

ByRidhi RastogiDecember 12, 2025

NEWS

GSK Reports the US FDA Approval of Blujepa for Uncomplicated Urogenital Gonorrhoea (uGC)

Shots: The US FDA has approved GSK's Blujepa (gepotidacin) for the treatment of pts (≥12yrs.; ≥45kg) with uGC caused by Neisseria gonorrhoeae who have limited or no alternative options for treatment Approval was backed by P-III (EAGLE-1) trial assessing Blujepa (2 doses × 3000mg; PO) vs ceftriaxone (500mg; IM) + azithromycin (1000mg; PO) in ~600 pts with…

ByRidhi RastogiDecember 12, 2025

NEWS

GSK’s Risvutatug Rezetecan Secures the US FDA’s Orphan Drug Designation for Treating SCLC

Shots: The US FDA has granted ODD to GSK’s risvutatug rezetecan (GSK5764227) for the treatment of small-cell lung cancer (SCLC) Designation was supported by preliminary P-I (ARTEMIS-001) trial data showing durable responses in pts with extensive-stage SCLC treated with risvutatug rezetecan GSK’227 is a B7-H3-targeted ADC developed by Hansoh Pharma for various solid tumors. GSK…

ByRidhi RastogiDecember 11, 2025

NEWS

Lumos Labs Reports the US FDA Clearance of LumosityRx for ADHD Patients

Shots: The US FDA has granted 510(k) clearance to LumosityRx, a prescription digital therapeutic, designed to improve attention in adults (22-55yrs.) with attention deficit hyperactivity disorder (ADHD) Assessed in the GAMES Study (n>500), LumosityRx showed significantly improved TOVA Attention Comparison Score (1EP) vs a control app, with 44.2% pts achieving clinically meaningful attention gains (>1.4 points…

ByRidhi RastogiDecember 11, 2025

NEWS

Formation Bio Licenses Lynk Pharmaceuticals’ LNK01006 to Expand its Immunology Pipeline

Shots: Lynk Pharmaceuticals has entered into an exclusive development & licensing agreement with Formation Bio, granting the latter worldwide rights to LNK01006 (excl. Greater China), a highly selective TYK2 inhibitor LNK01006 will be developed by Formation’s new subsidiary, Bleecker Bio, following recent US FDA IND clearance, with a P-I trial planned to start in the…

ByRidhi RastogiDecember 11, 2025

NEWS

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

The US FDA Approves Amgen’s Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis

GSK Reports the US FDA Approval of Blujepa for Uncomplicated Urogenital Gonorrhoea (uGC)

GSK’s Risvutatug Rezetecan Secures the US FDA’s Orphan Drug Designation for Treating SCLC

Lumos Labs Reports the US FDA Clearance of LumosityRx for ADHD Patients

Formation Bio Licenses Lynk Pharmaceuticals’ LNK01006 to Expand its Immunology Pipeline

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

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