Pharmaceutical

ARS Pharma’s epinephrine nasal spray 1mg now available ...

ARS Pharmaceuticals has announced the availability of neffy (epinephrine nasal s...

FDA plans to expand unannounced inspections of foreign ...

This move comes a day after President Trump signed an executive order to streaml...

European biotechs must understand US culture while seek...

At a time when investment has been low in biotech, establishing and maintaining ...

FDA grants RMAT status to Opus Genetics’ OPGx-LCA5 gene...

The US FDA has granted regenerative medicine advanced therapy (RMAT) designation...

Novo Nordisk cuts 2025 outlook due to compounding-hit W...

Novo Nordisk has cut its sales and profits forecasts for 2025 due to lower deman...

Sarepta shares fall amid FDA’s CBER appointment and wea...

Sarepta’s stock dropped by 26% after the FDA named a vocal critic of its gene th...

Solve FSHD to invest in Armatus Bio for ARM-201 develop...

Venture philanthropy organisation Solve FSHD has announced an investment of $3m ...

Expediting parallel drug approval pathways is challengi...

At the Swiss Biotech Day 2025, which took place on 5-6 May in Basel, a panel of ...

EC approves AstraZeneca’s Calquence combo to treat MCL

The European Commission (EC) has approved AstraZeneca's Bruton's tyrosine kinase...

Swiss biotech sector’s R&D investment grew in 2024 desp...

Research and development (R&D) investment in the Swiss biotech sector grew in 20...

FDA approves Selarsdi injection as interchangeable with...

Teva and Alvotech have announced receipt of the US FDA approval to Selarsdi inje...

TAE Life Sciences, Ohio State University partner to adv...

TAE Life Sciences (TLS) has signed a letter of intent with the OSUCCC – James to...

Chinese regulator grants priority review for InnoCare’s...

China NMPA's Center for Drug Evaluation (CDE) has granted priority review for In...

FDA accepts Novo Nordisk’s NDA submission for weight ma...

The US FDA has accepted Novo Nordisk’s new drug application (NDA) submission for...

Pliant cuts workforce by 45% following lung trial termi...

Pliant is slashing 45% of its workforce in a move to “minimise costs and preserv...