Pharmaceuticals

BlossomHill raises $168m IPO and wins FDA Fast Track for BH-30643

BlossomHill Therapeutics completed a $168m Nasdaq IPO and secured FDA Fast Track designation for its EGFR C797S inhibitor BH-30643 in NSCLC.
BlossomHill Therapeutics completed a $168m Nasdaq IPO and secured FDA Fast Track designation for its EGFR C797S inhibitor BH-30643 in NSCLC.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Novartis secukinumab gets positive CHMP opinion for PMR

The EMA's advisory committee has backed Cosentyx as the first IL-17A inhibitor for polymyalgia rheumatica in Europe, pending European Commission sign-off.
The EMA's advisory committee has backed Cosentyx as the first IL-17A inhibitor for polymyalgia rheumatica in Europe, pending European Commission sign-off.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Bavarian Nordic appoints Tarja Stenvall as CEO from October

The Danish vaccine company has named Sanofi and AstraZeneca veteran Tarja Stenvall as its new chief executive, effective 15 October 2026.
The Danish vaccine company has named Sanofi and AstraZeneca veteran Tarja Stenvall as its new chief executive, effective 15 October 2026.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals
Regulatory Science

Novo Nordisk's Sogroya wins CHMP backing for idiopathic short stature

A positive EMA committee opinion positions somapacitan as the first growth hormone treatment recommended for ISS in the EU, pending European Commission sign-off.
A positive EMA committee opinion positions somapacitan as the first growth hormone treatment recommended for ISS in the EU, pending European Commission sign-off.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Teva presents Phase 3 data on once-monthly olanzapine LAI TEV-'749

Post hoc SOLARIS data show 56% stabilisation and 4% relapse rates; an FDA decision on TEV-'749 is expected in Q4 2026.
Post hoc SOLARIS data show 56% stabilisation and 4% relapse rates; an FDA decision on TEV-'749 is expected in Q4 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics
Regulatory Science

Zealand Pharma gets CHMP nod for glepaglutide in short bowel syndrome

The EMA's CHMP has recommended Zeydovio for short bowel syndrome, the first major European advance in the indication for over a decade.
The EMA's CHMP has recommended Zeydovio for short bowel syndrome, the first major European advance in the indication for over a decade.
The Biotech Times Editorial Team  · 
Medical Devices

Treace Medical reports 5-year Lapiplasty data at AOFAS 2026

Three clinical studies presented at AOFAS 2026 show sustained outcomes for Treace's bunion correction systems, including a milestone five-year dataset.
Three clinical studies presented at AOFAS 2026 show sustained outcomes for Treace's bunion correction systems, including a milestone five-year dataset.
The Biotech Times Editorial Team  · 
AgriTech
Bioprocessing

Tanmiah opens R&D Innovation Center at Riyadh headquarters

Saudi poultry producer Tanmiah has inaugurated a micro-laboratory-scale Innovation Center to consolidate its entire product development cycle in-house.
Saudi poultry producer Tanmiah has inaugurated a micro-laboratory-scale Innovation Center to consolidate its entire product development cycle in-house.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Regulatory Science

Capricor to present 24-month Deramiocel DMD data at WMS 2026

Capricor Therapeutics will show HOPE-3 skeletal and cardiac outcomes data at the World Muscle Society Congress ahead of its November BLA action date.
Capricor Therapeutics will show HOPE-3 skeletal and cardiac outcomes data at the World Muscle Society Congress ahead of its November BLA action date.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Aquestive resubmits Anaphylm NDA after human factors and PK studies

Aquestive Therapeutics has refiled its FDA application for a needle-free sublingual epinephrine film after cutting pouch-opening time from 17 seconds to three.
Aquestive Therapeutics has refiled its FDA application for a needle-free sublingual epinephrine film after cutting pouch-opening time from 17 seconds to three.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

1ST Bio and SK Biopharma ink $314.8m Parkinson's licence for 1ST-104

The deal pairs 1STBIO's dual LRRK2/c-Abl inhibitor with SK Biopharmaceuticals' CNS development and commercialisation infrastructure.
The deal pairs 1STBIO's dual LRRK2/c-Abl inhibitor with SK Biopharmaceuticals' CNS development and commercialisation infrastructure.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Lisata Therapeutics acquires Marea and raises $225m in concurrent PIPE

Lisata is pivoting to cardioendocrine disease after acquiring Marea Therapeutics in a stock deal backed by a $225m oversubscribed private placement.
Lisata is pivoting to cardioendocrine disease after acquiring Marea Therapeutics in a stock deal backed by a $225m oversubscribed private placement.
The Biotech Times Editorial Team  · 
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