The US FDA Accepts Nicox’s NDA for NCX 470 in Glaucoma

Shots: The FDA has accepted NDA for NCX 470 (bimatoprost grenod) to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension (PDUFA: Apr 30, 2027) The NDA, submitted by US licensee Kowa, is supported by P-III (Mont Blanc & Denali) trial data showing IOP reductions of up to 10mmHg with a favorable safety…

ByRidhi Rastogi2 days ago

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United Therapeutics Reports the US FDA NDA Acceptance for Ralinepag to Treat Pulmonary Arterial Hypertension

Shots: The US FDA has accepted the NDA for ralinepag to treat pulmonary arterial hypertension, with PDUFA target action date of Jun 24, 2027 NDA was supported by the P-III (ADVANCE OUTCOMES) trial assessing ralinepag vs PBO in 687 patients with PAH, where pts who completed the trial had the option to enroll in ongoing…

ByRidhi RastogiAugust 25, 2026

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Amylyx Pharmaceuticals Reports Topline P-III (LUCIDITY) Trial Data on Avexitide in Post-Bariatric Hypoglycemia

Shots: The P-III (LUCIDITY) trial assessed avexitide (90mg, SC, QD) vs PBO in 78 adults with Post-Bariatric Hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) surgery Trial met its 1EP, showing a 55% reduction in the composite rate of Level 2 & Level 3 hypoglycemic events through Wk. 16. All 2EPs were also met, with consistent, highly…

ByRidhi RastogiAugust 18, 2026

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UroGen Submits NDA for UGN-103 to the US FDA for Recurrent LG-IR-NMIBC

Shots: The US FDA has received an NDA for UGN-103 (mitomycin; intravesical) to treat adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) The NDA is supported by the P-III (UTOPIA) trial in adults with recurrent LG-IR-NMIBC, where UGN-103 achieved a 77.8% 3mos. CR rate & a 94.5% 6mos. DoR by Kaplan-Meier estimate, consistent…

ByRidhi RastogiAugust 18, 2026

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Belite Bio Receives the US FDA Priority Review for Tinlarebant to Treat Stargardt Disease Type 1

Shots: The US FDA has accepted & granted Priority Review to the NDA for tinlarebant for the treatment of Stargardt Disease Type 1 (STGD1), with a PDUFA target date of Feb 12, 2027 NDA was supported by the P-III (DRAGON) trial assessing tinlarebant vs PBO in STGD1 pts, showing 35.7% reduction in atrophic retinal lesion growth…

ByRidhi RastogiAugust 12, 2026

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Revolution Medicines Reports the US FDA NDA Acceptance of Daraxonrasib for Previously Treated Metastatic PDAC

Shots: The US FDA has accepted the NDA for Revolution Medicines’ daraxonrasib to treat pts with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), plus daraxonrasib was selected for the FDA CNPV pilot program NDA was backed by P-III (RASolute 302) trial assessing daraxonrasib (300mg, QD, PO) vs CT, in above-mentioned pts, regardless of RAS mutation, which…

ByRidhi RastogiJuly 23, 2026

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BridgeBio Pharma Reports the US FDA’s NDA Acceptance for Encaleret to Treat Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Shots: The US FDA has accepted NDA for encaleret to treat ADH1, with a PDUFA date of May 8, 2027, & no advisory committee planned. BridgeBio is prepared for a potential launch, while an EU MAA filing is expected in H2’26 Encaleret was evaluated in the P-III (CALIBRATE) trial, which met its 1 & 2EPs,…

ByRidhi RastogiJuly 22, 2026

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Takeda Reports the P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis

Shots: Takeda has reported the 2 P-III (Latitude PsO 3001 & PsO 3002) trial results assessing zasocitinib (QD, PO) in 693 & 1108 adults, respectively, with mod. to sev. PsO, where both studies showed improved NAPSI scores vs PBO at 16wks. Trials also showed that 77% (3001) & 74% (3002) pts reached ssPGA 0/1 response…

ByRidhi RastogiJuly 17, 2026

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The US FDA Approves Celcuity’s Revtorpyk (Gedatolisib) to Treat HR+/HER2- PIK3CA Wild-Type Breast Cancer

Shots: FDA has approved Revtorpyk for HR+, HER2-, PIK3CA wild-type locally advanced or metastatic breast cancer that has progressed after ≥1L of endocrine therapy (ET) in the metastatic setting; launch expected in late Q3’26 Approval was backed by PIK3CA wild-type cohort data from P-III (VIKTORIA-1), where Revtorpyk + fulvestrant + palbociclib improved mPFS (9.3 vs…

ByRidhi RastogiJuly 15, 2026

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BMS Reports US FDA’s NDA Acceptance of Mezigdomide Combination to Treat R/R Multiple Myeloma

Shots: The US FDA has accepted NDA of mezigdomide (PO) + carfilzomib & dexamethasone (MeziKd) for the treatment of pts with r/r multiple myeloma (PDUFA: May 13, 2027) NDA was supported by the P-III (SUCCESSOR-2) trial data assessing MeziKd in 2 stages, where in stage 2, 479 pts with r/r MM were randomized to either MeziKd…

ByRidhi RastogiJuly 13, 2026

The US FDA Accepts Nicox’s NDA for NCX 470 in Glaucoma

United Therapeutics Reports the US FDA NDA Acceptance for Ralinepag to Treat Pulmonary Arterial Hypertension

Amylyx Pharmaceuticals Reports Topline P-III (LUCIDITY) Trial Data on Avexitide in Post-Bariatric Hypoglycemia

UroGen Submits NDA for UGN-103 to the US FDA for Recurrent LG-IR-NMIBC

Belite Bio Receives the US FDA Priority Review for Tinlarebant to Treat Stargardt Disease Type 1

Revolution Medicines Reports the US FDA NDA Acceptance of Daraxonrasib for Previously Treated Metastatic PDAC

BridgeBio Pharma Reports the US FDA’s NDA Acceptance for Encaleret to Treat Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Takeda Reports the P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis

The US FDA Approves Celcuity’s Revtorpyk (Gedatolisib) to Treat HR+/HER2- PIK3CA Wild-Type Breast Cancer

BMS Reports US FDA’s NDA Acceptance of Mezigdomide Combination to Treat R/R Multiple Myeloma

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