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- PMLiVE

Ipsen’s Sohonos gets FDA approval for fibrodysplasia ossificans progressive

The drug is the first-ever treatment approved in the US for patients with the disease

- PMLiVE

Janssen’s Talvey granted FDA accelerated approval for difficult-to-treat blood cancer

The therapy showed an overall response rate of more than 70% in a broad range of patients

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Roche’s Genentech and Blueprint receive full FDA approval for Gavreto in lung cancer

The targeted therapy was granted accelerated approval for the NSCLC indication in 2020

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GSK files lawsuit against Pfizer over RSV vaccine patent infringement

The RSV vaccine market is estimated to exceed $5bn and could surpass $10bn by 2030

- PMLiVE

FDA approves Taiho’s stronger Lonsurf regimen for metastatic colorectal cancer

The approval comes almost eight years after the regulator approved Lonsurf as a monotherapy for the same indication

- PMLiVE

GSK’s Jemperli combination receives FDA approval for endometrial cancer

Approximately 60,000 new cases of endometrial cancer are diagnosed every year in the US

- PMLiVE

FDA approves second over-the-counter naloxone nasal spray for opioid overdose

Over 105,000 fatal opioid overdoses were reported in the US between 2022 and 2023

- PMLiVE

AstraZeneca’s rare disease unit to acquire Pfizer’s early-stage gene therapies for $1bn

The transaction could potentially see staff associated with the portfolio move to Alexion

- PMLiVE

Pfizer and Flagship Pioneering sign drug discovery partnership worth up to $7bn

The partners will each invest $50m upfront to develop up to ten new drug candidates

- PMLiVE

US FTC requests more information on Pfizer’s proposed $43bn Seagen acquisition

The transaction would mark a significant boost to Pfizer’s oncology pipeline

- PMLiVE

Gilead’s COVID-19 treatment approved by FDA for patients with severe renal impairment

Use of Veklury among this patient population has previously been limited

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Biogen/Eisai’s Alzheimer’s disease drug granted full FDA approval

Leqembi was granted accelerated approval earlier this year for patients with early Alzheimer's disease

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