Samsung Bioepis and Harrow Relaunch Byooviz (Biosimilar, Lucentis) in the US

Shots: Samsung Bioepis, in partnership with Harrow, has relaunched Byooviz, a biosimilar to Lucentis (ranibizumab), in the US Byooviz was initially commercialized by Biogen beginning in Jun 2022, before Biogen returned the US commercial rights to Samsung Bioepis at the end of 2025 Approved by the FDA in 2021 as the first ophthalmology biosimilar, Byooviz…

ByRidhi RastogiJuly 1, 2026

NEWS

Novo Nordisk Reports the US FDA’s BLA Submission of Mim8 (Denecimig) for Haemophilia A with or without Inhibitors

Shots: The US FDA has accepted the BLA for Mim8 (denecimig; pre-filled, single-use pen) as routine prophylaxis to prevent or reduce bleeding episodes in adult & pediatric pts with hemophilia A (congenital FVIII deficiency), with or without inhibitors BLA was supported by FRONTIER2 trial assessing Mim8 (QW/QM) in pts (≥12yrs), FRONTIER3 trial assessing it in…

ByRidhi RastogiSeptember 30, 2025

NEWS

RAPT Therapeutics Receives the US FDA’s IND Clearance to Evaluate RPT904 for Food Allergy

Shots: The US FDA has granted IND clearance to initiate P-IIb (prestIgE) trial of RPT904 for the treatment of pts with IgE-mediated food allergy by the end of 2025 The P-IIb (prestIgE) trial will assess RPT904 (SC; loading at Wk. 2, then Q8W or Q12W) vs PBO in 2 parts: In Part 1, ~100 pts with ≥1 food…

ByRidhi RastogiSeptember 30, 2025

INSIGHTS+

The US FDA New Drug Approvals in November 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of November 2024 The US FDA has approved a total of 5 new drugs including 4 new molecular entities and 1 biologic leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was Jazz Pharmaceuticals’ Ziihera…

ByDipanshu DixitDecember 10, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in July 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of July 2024 The US FDA approved a total of 2 new drugs including 1 new molecular entity and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was Eli Lilly’s Kisunla for…

ByDipanshu DixitAugust 13, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in June 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of June 2024 The US FDA approved a total of 5 new drugs including 4 new molecular entities and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was Ipsen’s Iqirvo for the treatment…

ByDipanshu DixitJuly 16, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in May 2024

Shots: The EMA approved or granted Positive Opinions to 5 Biologics and 7 New Chemical Entities in May 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were BMS’ Opdivo + cisplatin & gemcitabine to treat Urothelial Carcinoma and Takeda’s ADAMTS13 for the treatment cTTP PharmaShots has compiled…

ByDipanshu DixitJune 20, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in May 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of May 2024 The US FDA approved a total of 3 new drugs including 2 new molecular entities and 1 biologic leading to treatments for patients and advances in the healthcare industry The major highlighted drug was Amgen’s Imdelltra for the treatment…

ByDipanshu DixitJune 18, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in April 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of April 2024 The US FDA approved a total of 12 new drugs including 11 new molecular entities and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was X4 Pharmaceuticals’ Xolremdi for…

ByDipanshu DixitMay 14, 2024

Samsung Bioepis and Harrow Relaunch Byooviz (Biosimilar, Lucentis) in the US

Novo Nordisk Reports the US FDA’s BLA Submission of Mim8 (Denecimig) for Haemophilia A with or without Inhibitors

RAPT Therapeutics Receives the US FDA’s IND Clearance to Evaluate RPT904 for Food Allergy

The US FDA New Drug Approvals in November 2024

Insights+: The US FDA New Drug Approvals in July 2024

Insights+: The US FDA New Drug Approvals in June 2024

Insights+: EMA Marketing Authorization of New Drugs in May 2024

Insights+: The US FDA New Drug Approvals in May 2024

Insights+: The US FDA New Drug Approvals in April 2024

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