Today, the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to delpacibart etedesiran (AOC 1001). This is USA-based Avidity Biosciences’ (Nasdaq: RNA) lead ...

Aspaveli is already approved in Europe for the treatment of adults with PNH who are anemic after treatment with a C5 inhibitor for at least three months.

Psychopharmacologic Drugs Advisory Committee (PDAC) will review data supporting the new drug application (NDA) submitted by Lykos Therapeutics for midomafetamine (MDMA) capsules used in combination ...

Flagship has initially committed $50 million to advance the company’s unique platform, which will be used to develop a pipeline of medicines for a range of diseases. Prologue, which was founded in ...

Chinese metabolic disease company Sciwind Biosciences has inked a deal with HK inno.N (Kosdaq: 195940), a South Korean commercial stage drugmaker. The licensing and partnership agreement relates to ...

US pharma giant Pfizer (NYSE: PFE) shared some sad clinical trial news Tuesday. The company disclosed that a boy taking part in the Phase II DAYLIGHT study for Duchenne muscular dystrophy (DMD) had ...

Following a couple of delays on reviewing US pharma major Eli Lilly’s (NYSE: LLY) marketing application for its Alzheimer’s disease candidate donanemab, the US Food and Drug Administration (FDA) has ...

Final results from a three-year open-label extension study of Fintepla (fenfluramine) have been released by Belgium’s UCB (Euronext: UCB). Presented at the International Child Neurology Congress (ICNC ...

India’s Bharat Biotech (BBIL) and Bilthoven Biologicals (BBio), the Dutch subsidiary of the Serum Institute of India, have inked a pact to manufacture oral polio vaccines (OPVs) in India. Under an ...

The US drugmaker Baxter (NYSE: BAX), one of the largest suppliers of dialysis solutions, has suspended its commercial activities in Russia, according to recent statements made in the company’s ...

Privately-held Isotope Technologies Munich (ITM) has announced the appointment of Danielle Meyrick as chief medical officer (CMO). She replaces Philip Harris, ITM’s CMO from 2018, who is retiring from ...

Half of pharma execs are bracing for significant revenue impact from Medicare price negotiations this year, compared to just 22% in 2023, according to research from revenue and compliance experts at ...