Womed Reports the US FDA’s Approval of Womed Leaf to Treat Asherman Syndrome

Shots: The US FDA has approved the PMA application of Womed Leaf for women undergoing hysteroscopic surgery for symptomatic moderate to severe intrauterine adhesions (Asherman syndrome); commercial launch expected in early 2026 Womed Leaf was evaluated in the PREG2 trial (n=160) for mod. to sev. intrauterine adhesions, showing reduced severity of intrauterine adhesion after hysteroscopic…

ByRidhi RastogiSeptember 16, 2025

NEWS

Ocugen Joins Forces with Kwangdong Pharmaceutical for OCU400 to Treat Retinitis Pigmentosa

Shots: Ocugen has entered into a licensing agreement with Kwangdong Pharmaceutical for OCU400 to treat retinitis pigmentosa As per the deal, Kwangdong will receive exclusive Korean rights to OCU400 in exchange for $7.5M in upfront & near-term milestones, $1.5M per $15M in sales, reaching ≥$180M in sales milestones, plus 25% royalties on net sales, while…

ByRidhi RastogiSeptember 15, 2025

NEWS

Ionis’ ION582 Receives the US FDA’s Breakthrough Therapy Designation to Treat Angelman Syndrome

Shots: The US FDA has granted BTD to ION582 (UBE3A protein expression stimulant) for the treatment of Angelman syndrome Designation was based on P-I/II (HALOS) trial assessing ION582 in pts with Angelman syndrome, which showed improvements across all functional domains incl. communication, cognition & motor function; safety was favorable Additionally, ION582 is being investigated in…

ByRidhi RastogiSeptember 12, 2025

NEWS

Tempus AI Receives the US FDA’s 510(k) Clearance for Updated Tempus Pixel Cardiac Imaging Platform

Shots: Tempus AI has received the US FDA 510(k) clearance for its updated Tempus Pixel, an AI-powered cardiac imaging platform, with the ability to generate T1 & T2 inline maps for enhanced cardiac MRI analysis Tempus Pixel delivers advanced viewing & automated reporting of cardiac MR images, improving efficiency and accuracy in flow visualization, functional…

ByRidhi RastogiSeptember 12, 2025

NEWS

Corcept Therapeutics Reports the US FDA’s NDA Acceptance of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Shots: The US FDA has accepted NDA of relacorilant for the treatment of Pt-resistant ovarian cancer (PDUFA: Jul 11, 2026) NDA was supported by P-III (ROSELLA) & P-II trials, where relacorilant + nab-paclitaxel demonstrated improved PFS & OS compared to nab-paclitaxel monotx., with no need for biomarker selection & favorable safety Additionally, relacorilant (GR antagonist)…

ByRidhi RastogiSeptember 11, 2025

NEWS

Exact Sciences Launches Cancerguard Test for Early Multi-Cancer Detection

Shots: Exact Sciences has introduced the Cancerguard test for early multi-cancer detection & has partnered with Quest Diagnostics to expand patient access in the US Cancerguard is supported by extensive clinical data, incl. DETECT-A & ASCEND 2 studies in over 20,000 subjects. Additionally, Exact is enrolling ~25,000 participants in the Falcon registry study following the…

ByRidhi RastogiSeptember 10, 2025

NEWS

Sobi Reports the US FDA’s BLA Acceptance of Nanoecapsulated Sirolimus + Pegadricase for Uncontrolled Gout

Shots: The US FDA has accepted the BLA of Nanoecapsulated Sirolimus + Pegadricase (NASP; Q4W) for the treatment of uncontrolled gout (PDUFA: Jun 27, 2026) BLA was supported by P-III (DISSOLVE I & II) trials evaluating 2 NASP doses vs PBO in adults with uncontrolled gout, which met its 1EP of sustained decrease in serum…

ByRidhi RastogiSeptember 10, 2025

NEWS

The US FDA Approves Johnson & Johnson’s Inlexzo for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

Shots: The US FDA has approved Inlexzo for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS &/or papillary tumors Approval was based on the P-IIb (SunRISe-1) trial, assessing Inlexzo in pts ineligible or opting out of radical cystectomy, which showed an 82% CR rate, with 51% remaining cancer-free for at least 1yr. post-response Inlexzo is…

ByRidhi RastogiSeptember 10, 2025

INSIGHTS+

The US FDA New Drug Approvals in August 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of August 2025 The US FDA has approved a total of 5 new drugs, including 5 new molecular entities, leading to the treatment of patients and advances in the pharmaceutical industry The major highlighted drug was Jazz Pharmaceuticals’ Modeyso, securing FDA approval…

ByDipanshu DixitSeptember 9, 2025

NEWS

Pulse Biosciences Receives FDA IDE Approval for nsPFA Cardiac Surgery System to Treat Atrial Fibrillation

Shots: Pulse Biosciences has received the US FDA IDE approval to initiate its NANOCLAMP AF study evaluating nsPFA system in ~136 pts with atrial fibrillation (AF) across 20 sites, incl. 2 outside the US The EU feasibility study of nsPFA Cardiac Clamp began in Aug 2024 with over 40 pts across 3 sites The Netherlands,…

ByRidhi RastogiSeptember 9, 2025

Womed Reports the US FDA’s Approval of Womed Leaf to Treat Asherman Syndrome

Ocugen Joins Forces with Kwangdong Pharmaceutical for OCU400 to Treat Retinitis Pigmentosa

Ionis’ ION582 Receives the US FDA’s Breakthrough Therapy Designation to Treat Angelman Syndrome

Tempus AI Receives the US FDA’s 510(k) Clearance for Updated Tempus Pixel Cardiac Imaging Platform

Corcept Therapeutics Reports the US FDA’s NDA Acceptance of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Exact Sciences Launches Cancerguard Test for Early Multi-Cancer Detection

Sobi Reports the US FDA’s BLA Acceptance of Nanoecapsulated Sirolimus + Pegadricase for Uncontrolled Gout

The US FDA Approves Johnson & Johnson’s Inlexzo for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

The US FDA New Drug Approvals in August 2025

Pulse Biosciences Receives FDA IDE Approval for nsPFA Cardiac Surgery System to Treat Atrial Fibrillation

Contact US

FOLLOW US