Samsung Bioepis Reports the EC Launch of Opuviz (Biosimilar, Eylea)

Shots: Samsung Bioepis to directly commercialize Opuviz 40 mg/mL solution for injection in a vial, a biosimilar version of Eylea (aflibercept), across the EU Opuviz is indicated to treat wet age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), diabetic macular oedema (DME), and…

ByRidhi RastogiMay 29, 2026

NEWS

AstraZeneca Receives the US FDA Approval for Imfinzi Regimen to Treat High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Shots: The US FDA has approved AZ's Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction & maintenance therapy for the treatment of adults with BCG-naïve, high-risk NMIBC; regulatory review is ongoing in the EU & Japan Approval was based on the P-III (POTOMAC) trial of 1018 high-risk, BCG-naïve NMIBC pts post-TURBT, randomized to Imfinzi…

ByRidhi RastogiMay 29, 2026

NEWS

Pfizer and Innovent Biologics Partner to Accelerate 12 Oncology Programs in a Deal Valued at ~$10.5B

Shots: Innovent will advance the early-stage & de novo cancer therapies, incl. ADCs through P-I before Pfizer assumes global development, with Pfizer securing exclusive global rights to 4 programs & will be responsible for the global development costs Also, Pfizer will obtain exclusive ex-Greater China rights to 4 additional programs & fund the majority of development…

ByRidhi RastogiMay 29, 2026

NEWS

Ironwood Pharmaceuticals Reports the US FDA Approval of Linzess to Treat Pediatric Patients (≥2yrs.) with Functional Constipation

Shots: The US FDA has approved label expansion of Linzess (linaclotide) in pts (≥2yrs.) for the treatment of functional constipation (FC) Approval was supported by data from a 12wk. P-III trial assessing Linzess in pediatric pts (2-5yrs.) with FC, where Linzess (72mcg) showed improvement in spontaneous bowel movement frequency vs PBO Linzess contains linaclotide, a…

ByRidhi RastogiMay 28, 2026

NEWS

Apogee Therapeutics Reports Part B P-II (APEX) Data on Zumilokibart in Atopic Dermatitis (AD)

Shots: Part B of P-II (APEX) trial assessed high, medium, or low-dose zumilokibart vs PBO in 346 pts, where mid & high-doses met the 1EP at 16wks., with 61.6% pts on high dose, 65.9% on mid-dose & 50.5% on low dose achieved EASI-75 vs 23.4% on PBO At Wk. 16, mid-dose also met key 2EP…

ByRidhi RastogiMay 28, 2026

NEWS

GSK Reports the P-III (B-Well 1 and B-Well 2) Trial Data on Bepirovirsen for Chronic Hepatitis B at EASL 2026

Shots: GSK has reported data from the P-III (B-Well 1 & B-Well 2) trials assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline HBsAg ≤3000 IU/ml. Bepirovirsen is under regulatory review in the US, EU, China & Japan Pooled data showed a 19% functional cure rate (1EP) in the overall population (233/1,220…

ByRidhi RastogiMay 28, 2026

NEWS

Cardiosense Receives FDA De Novo Classification for its PCWP Analysis Software

Shots: The FDA has granted De Novo classification to Cardiosense's PCWP Analysis Software to noninvasively estimate pulmonary capillary wedge pressure (PCWP) in adults with heart failure with reduced ejection fraction (HFrEF), incl. those with LVEF ≤40% & NYHA Class II, III & IV symptoms The Software integrates its CardioTag wearable sensor with AI to…

ByRidhi RastogiMay 28, 2026

NEWS

Sanofi’s Venglustat Secures the US FDA Priority Review for Type 3 Gaucher Disease

Shots: The US FDA has accepted NDA & granted priority review to Sanofi's venglustat for the treatment of neurological manifestations of type 3 Gaucher disease (GD3), with the PDUFA action date of Nov 25, 2026 NDA was supported by the ongoing P-III (LEAP2MONO) trial assessing venglustat (QD, PO) vs enzyme replacement therapy (IV, Q2W) in 43 pts…

ByRidhi RastogiMay 28, 2026

NEWS

AbbVie Reports the US FDA Approval for Decnupaz to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Shots: The US FDA has approved AbbVie's Decnupaz (pivekimab sunirine-pvzy) for the treatment of adults with BPDCN Approval was supported by the global P-I/II (CADENZA) trial in 84 pts with CD123+ hematologic malignancies, incl. BPDCN, where pts received Decnupaz in both frontline (n=33) & relapsed/refractory (R/R) settings (n=51) without active CNS disease Trial reported a 69.7% composite…

ByRidhi RastogiMay 28, 2026

NEWS

Apogee Therapeutics Secures Up to $1.3B Financing from Blackstone to Advance Zumilokibart

Shot: Apogee will receive ~$1.3B in flexible, non-dilutive capital from Blackstone, incl. ~$800M of synthetic royalty & ~$500M in senior debt available at the mutual consent of both parties, to support the late-stage development & potential commercialization of zumilokibart Blackstone will provide ~$800M in synthetic royalty funding to Apogee in exchange for 15-year tiered royalties…

ByRidhi RastogiMay 27, 2026

Ridhi Rastogi

Samsung Bioepis Reports the EC Launch of Opuviz (Biosimilar, Eylea)

AstraZeneca Receives the US FDA Approval for Imfinzi Regimen to Treat High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Pfizer and Innovent Biologics Partner to Accelerate 12 Oncology Programs in a Deal Valued at ~$10.5B

Ironwood Pharmaceuticals Reports the US FDA Approval of Linzess to Treat Pediatric Patients (≥2yrs.) with Functional Constipation

Apogee Therapeutics Reports Part B P-II (APEX) Data on Zumilokibart in Atopic Dermatitis (AD)

GSK Reports the P-III (B-Well 1 and B-Well 2) Trial Data on Bepirovirsen for Chronic Hepatitis B at EASL 2026

Cardiosense Receives FDA De Novo Classification for its PCWP Analysis Software

Sanofi’s Venglustat Secures the US FDA Priority Review for Type 3 Gaucher Disease

AbbVie Reports the US FDA Approval for Decnupaz to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Apogee Therapeutics Secures Up to $1.3B Financing from Blackstone to Advance Zumilokibart

Contact US

FOLLOW US