Merck announces EC approval of Ogsiveo for desmoid tumours
The European Commission (EC) has granted marketing authorisation to SpringWorks Therapeutics, a subsidiary of Merck KGaA, for Ogsiveo (nirogacestat) to…
18 Aug 2025
Boehringer Ingelheim marks retinal disease push with $327m licensing deal
Boehringer Ingelheim currently does not have any approved therapies for ophthalmic indications, but the company is looking to change that via a new $250m licensing deal with a US biotech.…
18 Aug 2025
FDA approves Papzimeos as first therapy for HPV-caused airway disease
The US Food and Drug Administration (FDA) has approved the first treatment for recurrent respiratory papillomatosis (RRP), a rare respiratory tract disease caused by human papillomavirus (HPV) that requires patients…
18 Aug 2025
Wegovy becomes first GLP-1RA to gain FDA MASH approval
Danish big pharma Novo Nordisk has been given the go-ahead for its star weight loss drug, Wegovy (semaglutide), in patients with metabolic dysfunction-associated steatohepatitis (MASH) who have moderate-to-advanced liver scarring.…
18 Aug 2025
Aquestive signs $75m agreement for launch of Anaphylm
Aquestive Therapeutics has made a strategic funding agreement worth $75m with RTW Investments to support the potential launch of Anaphylm (epinephrine) sublingual film, a matrix-based epinephrine prodrug product candidate. The…
18 Aug 2025
Sanofi receives orphan status from EMA for rilzabrutinib
Sanofi has received orphan designation from the European Medicines Agency (EMA) for rilzabrutinib, a reversible covalent Bruton’s tyrosine kinase (BTK) inhibitor, to treat immunoglobulin G4 (IgG4)-related disease (IgG4-RD), a rare…
18 Aug 2025
FDA approves Tonix’s Tonmya to treat fibromyalgia
Tonix Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for Tonmya (cyclobenzaprine HCl sublingual tablets) to treat fibromyalgia in adults. Fibromyalgia is a chronic pain condition…