Ligand Pharmaceuticals’ Zelsuvmi Receives the US FDA’s Approval for the Treatment of Molluscum Contagiosum

Shots: Zelsuvmi (berdazimer topical gel, 10.3%) received the US FDA’s approval as a novel drug for the treatment of molluscum infections in adults & pediatric patients aged ≥1yrs. Zelsuvmi is expected to be commercially available in the US by H2’24 The company evaluated the safety & effectiveness of the US FDA-approved Zelsuvmi in P-III clinical…

ByDipanshu DixitJanuary 8, 2024

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Björn Mellgård shares insights from the Pivotal Phase III data of TAK-755 for congenital thrombotic thrombocytopenic purpura (cTTP)

Shots: Björn Mellgård Vice President and Global Program Lead, TTP Program, Takeda, shares insights from the P-III data of TAK-755 for the treatment of cTTP Björn eloquently shares the highlights of the study design for TAK-755, safety and efficacy outcomes, and goes on to share an update from the P-IIIb continuation trial evaluating TAK-755 With…

BySaurabh ChaubeyOctober 19, 2023

THOUGHTSPOT

What are the Services Offered by Gastroenterologist?

Introduction A gastroenterologist is a professional who diagnoses stomach and digestive problems. An individual can only focus on his daily chores if his health is fit and fine. Nowadays, individuals suffer from various digestive issues, and if these symptoms are ignored, they can lead to a severe problem. A professional gastroenterologist possesses a variety of…

ByHaikle LeeSeptember 25, 2023

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Unveiling FDA Acceptance: Ahsan Arozullah of Astellas Dives into Insights on PADCEV sBLAs for UC patients

Shots: Ahsan spoke about the US FDA acceptance for Priority Review of sBLAs for PADCEV and KEYTRUDA to treat patients with LA/mUC who are not eligible to receive cisplatin-containing CT He also talked about the study design and outcomes from the P-Ib/II (EV-103) clinical trial that supported the sBLA. The results from Dose Escalation/Cohort A…

BySenior EditorAugust 17, 2023

INSIGHTS+

Insights+: The US FDA New Drug Approvals in July 2023

Shots: The US FDA approved 5 NDAs and 2 BLA in July 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 76 novel products in 2023 In July 2023, the major highlights drugs were Beyfortus (nirsevimab) approval for the prevention of RSV lower respiratory tract disease in…

BySenior EditorAugust 16, 2023

INSIGHTS+

Insights+: The US FDA New Drug Approvals in February 2023

Shots: The US FDA approved 5 NDAs and 5 BLA in February 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 19 novel products in 2023 In February 2023, the major highlights drugs were, Tezspire (tezepelumab) approval for severe asthma, Altuviiio for hemophilia A PharmaShots has compiled…

BySenior EditorMarch 15, 2023

THOUGHTSPOT

Getting on with Rare Disease Therapeutic Options (Orphan Disease Therapies)

Shots: With the healthcare sector moving ahead with its technological advances, there is still an unexplored section in therapeutics that requires much more attention. Through innovations, life science companies have evolved to make breakthrough discoveries in many focus areas, but when it comes to the rare disease segment, all our endeavors seem to be bleak…

BySaurabh ChaubeyMarch 14, 2023

INSIGHTS+

J.P. Morgan Special: Dealmaker 2022 – Top M&A Deal of Roche (Part 01)

Shots: Roche was the top dealmaker in 2022 with a completion of 31 deals with multiple pharma, biotech companies, and universities for a total deal value of $13.55B The highest deal was secured by Roche under its development and commercialization collaboration with Poseida for the R&D of multiple existing and novel cell therapies for the…

BySenior EditorJanuary 5, 2023

INSIGHTS+

Insights+: The US FDA New Drug Approvals in October 2022

The US FDA approved 1 NDAs and 2 BLA in October 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 66 novel products in 2022 In October 2022, the major highlights drugs were Tecvayli’s approval for relapsed or refractory multiple myeloma, Furoscix for congestion in chronic heart…

BySenior EditorNovember 17, 2022

INSIGHTS+

Top Performing Drug of 2021 – Biktarvy (October Edition)

Active Ingredient: bictegravir, emtricitabine, and tenofovir alafenamide Strength: 50 mg of BIC, 200 mg of FTC, and 25 mg of TAF/ 30 mg of BIC, 120 mg of FTC, and 15 mg of TAF Dosage Form: Tablet Mechanism of Action: HIV reverse transcriptase inhibitors First Approval: US (07 Feb 2018), EU (25 Jun 2018) Revenue1 Gilead's HIV drug, Biktarvy has…

BySenior EditorOctober 27, 2022

Ligand Pharmaceuticals’ Zelsuvmi Receives the US FDA’s Approval for the Treatment of Molluscum Contagiosum

Björn Mellgård shares insights from the Pivotal Phase III data of TAK-755 for congenital thrombotic thrombocytopenic purpura (cTTP)

What are the Services Offered by Gastroenterologist?

Unveiling FDA Acceptance: Ahsan Arozullah of Astellas Dives into Insights on PADCEV sBLAs for UC patients

Insights+: The US FDA New Drug Approvals in July 2023

Insights+: The US FDA New Drug Approvals in February 2023

Getting on with Rare Disease Therapeutic Options (Orphan Disease Therapies)

J.P. Morgan Special: Dealmaker 2022 – Top M&A Deal of Roche (Part 01)

Insights+: The US FDA New Drug Approvals in October 2022

Top Performing Drug of 2021 – Biktarvy (October Edition)

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