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

Shots: The US FDA approved 6 NDAs and 4 BLA in April 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 36 novel products in 2023 In April 2023, the major highlights drugs were, Trikafta approval for children with cystic fibrosis, Qalsody for the treatment of amyotrophic…

BySenior EditorMay 17, 2023

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Rami Apelian and Marija Geertsen Share Insights from 9 Poster Presentations on Migraine Prevention & Treatment at AHS 2022

Shots: Rami spoke about study design of the P-III study evaluating its lead candidate in migraine Marija Geertsen talked about different treatment options available for migraine & neurological diseases The interview highlights the development plans and global expansion of various therapies for brain diseases Smriti: Explain the details (MOA, ROA, formulations, etc.) of Vyepti. Rami Apelian: VYEPTI®…

BySenior EditorAugust 29, 2022

INSIGHTS+

Insights+: The US FDA New Drug Approvals in February 2020

The US FDA has approved multiple NDAs and BLAs in Feb 2020, leading to treatments for patients and advances in health care The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 13 novel products so far in 2020, including 10 in Feb and 3 in Jan…

BySenior EditorMarch 27, 2020

INSIGHTS+

PharmaShots’ Key Highlights of Third Quarter 2019

The third quarter of 2019 has ended with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisition where Biocon Biologics acquires Pfizer's Research Facility for expansion of its R&D footprints with the acceleration of the development of its biosimilars from lab to pilot scale. Previously, Amgen acquired…

BySenior EditorSeptember 7, 2019

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

Rami Apelian and Marija Geertsen Share Insights from 9 Poster Presentations on Migraine Prevention & Treatment at AHS 2022

Insights+: The US FDA New Drug Approvals in February 2020

PharmaShots’ Key Highlights of Third Quarter 2019

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