Omeros Reports the US FDA’s Acceptance of Resubmitted BLA for Narsoplimab to Treat TA-TMA

Shots:The US FDA has accepted the Class 2 BLA resubmission of narsoplimab for the treatment of HSCT-associated thrombotic microangiopathy (TA-TMA), with PDUFA goal date assigned in late Sept 2025; EMA’s MAA filing expected by late Q2’25The BLA resubmission incl. primary set of survival analyses, showing improved OS in TA-TMA pts, along with survival…

ByRidhi RastogiMay 7, 2025

News

Vanda Pharmaceuticals Reports the US FDA’s NDA Acceptance of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia

Shots:The US FDA has accepted NDA of Bysanti, an active metabolite of iloperidone to treat acute bipolar I disorder & schizophrenia (PDUFA: Feb 21, 2026). If approved, Bysanti may receive 5yrs. of data exclusivity, with pending patents extending into the 2040sNDA is backed by various iloperidone trials, incl. 2 in acute schizophrenia, 1…

ByRidhi RastogiMay 6, 2025

News

Novo Nordisk Reports the US FDA’s NDA Acceptance of Oral Wegovy for Weight Management

Shots:The US FDA has accepted NDA of oral Wegovy for chronic weight management & major adverse CV events risk reduction in adults with obesity or overweight & comorbidities (PDUFA: Q4’25)Submission was based on the P-III (OASIS 4) trial assessing oral Wegovy (25mg; OD) vs PBO over 64wks. (incl. 12wk. dose escalation & 7wk.…

ByRidhi RastogiMay 5, 2025

News

Regeneron’s Lynozyfic (Linvoseltamab) Receives the EC’s Conditional Approval for R/R Multiple Myeloma

Shots:The EC has granted conditional approval to Lynozyfic for the treatment of adults with r/r multiple myeloma based on P-I/II (LINKER-MM1) trial data assessing Lynozyfic in >300 pts; P-II dose expansion portion is ongoing. BLA under the US FDA’s Review (PDUFA: Jul 10, 2025)In the trial, 117 pts on 200mg had a 71% ORR, with…

ByRidhi RastogiApril 29, 2025

News

Merck Reports P-III (KEYNOTE-689) Trial Data of Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma

Shots:The P-III (KEYNOTE-689) trial assessed neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (× 15 cycles) + SoC radiotherapy (RT) ± cisplatin vs adj. SoC RT without cisplatin in treatment-naïve pts (n=714) with stage III/IVA resected LA-HNSCC; sBLA under the FDA’s review (PDUFA: Jun 23, 2025)At 38.3 mos. mFU,…

ByRidhi RastogiApril 28, 2025

News

PTC Therapeutics’ Sephience Receives the CHMP’s Positive Opinion for the Treatment of Phenylketonuria (PKU)

Shots: The CHMP has issued a positive opinion recommending marketing authorization for Sephience (sepiapterin) to treat PKU in patients of all ages and disease severities, expected the EC approval within two mos., with the decision applying across the EU including Iceland, Norway, and Liechtenstein Sepiapterin's NDA is under FDA review (PDUFA: July 29, 2025), and…

ByDipanshu DixitApril 25, 2025

News

BMS Reports the US FDA’s Approval of Opdivo + Yervoy as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)

Shots:The US FDA has approved Opdivo + Yervoy for 1L treatment of MSI-H/dMMR unresectable mCRC pts (≥12yrs.) based on P-III (CheckMate-8HW) study assessing Opdivo + Yervoy vs Opdivo alone or CT in 839 pts (Approved before PDUFA: Jun 23, 2025)Regimen vs Opdivo monotx. showed 38% PFS (mPFS: not reached (NR) vs 39.3mos) in…

ByRidhi RastogiApril 9, 2025

News

Merck Presents P-III (3475A-D77) Trial Data of SC Keytruda for NSCLC at ELCC 2025

Shots:The P-III (3475A-D77) trial assessed SC Keytruda (Q6W) + berahyaluronidase alfa + CT vs IV Keytruda (Q6W) + CT in 1L metastatic NSCLC adults (n=377), regardless of PD-L1 TPS expression; BLA under the US FDA’s review (PDUFA: Sep 23, 2025) & MAA under EMA’s reviewTrial showed that SC is noninferior to IV in AUC…

ByRidhi RastogiMarch 28, 2025

INSIGHTS+

New Drug Designations – November 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EMA and China. This month’s report includes 3 biological drugs, 12 small molecules, 13 cell and gene therapies, 1 peptide, 3 exosome-based therapy and 4 devices Atsena Therapeutics’ capsid AAV.SPR gene therapy, focused on the treatment of Leber congenital…

BySenior EditorDecember 27, 2023

Omeros Reports the US FDA’s Acceptance of Resubmitted BLA for Narsoplimab to Treat TA-TMA

Vanda Pharmaceuticals Reports the US FDA’s NDA Acceptance of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia

Novo Nordisk Reports the US FDA’s NDA Acceptance of Oral Wegovy for Weight Management

Regeneron’s Lynozyfic (Linvoseltamab) Receives the EC’s Conditional Approval for R/R Multiple Myeloma

Merck Reports P-III (KEYNOTE-689) Trial Data of Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma

PTC Therapeutics’ Sephience Receives the CHMP’s Positive Opinion for the Treatment of Phenylketonuria (PKU)

BMS Reports the US FDA’s Approval of Opdivo + Yervoy as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)

Merck Presents P-III (3475A-D77) Trial Data of SC Keytruda for NSCLC at ELCC 2025

New Drug Designations – November 2023

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