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- 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

Biogen Idec building

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

- PMLiVE

FDA declines to approve Amneal Pharmaceuticals’ Parkinson’s disease treatment

The regulator said the safety for one of the drug's ingredients had not been adequately established

- PMLiVE

FDA approves BioMarin’s Roctavian as first gene therapy for severe haemophilia A

Approximately 2,500 patients are expected to be eligible to receive the one-time therapy

- PMLiVE

FDA approves CellTrans’ Lantidra as first cellular therapy to treat type 1 diabetes

The therapy is indicated for use in patients who are unable to meet their target blood glucose levels

- PMLiVE

FDA grants fast track designation to AC Immune’s Alzheimer’s disease vaccine

The decision was supported by interim results from a low dose cohort of the phase 1b/2 ABATE trial

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