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February 3, 2026

Aquestive receives FDA CRL for Anaphylm allergic reaction treatment

Aquestive Therapeutics has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its new drug application (NDA) for Anaphylm, a sublingual film formulation of dibutepinephrine.

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The original NDA included 11 clinical studies with approximately 967 total administrations across 411 participants. Credit: Sai Thaw Kyar / Shutterstock.com.
February 3, 2026

SanegeneBio and Genentech sign $1.5bn global RNAi licensing deal

The collaboration focuses on SanegeneBio’s RNAi platform, featuring new chemistries and delivery technologies for siRNA medicines. Credit: luchschenF / Shutterstock.com.
February 2, 2026

CHMP grants positive opinion for J&J’s Akeega use

The CHMP recommends the use of niraparib and abiraterone acetate for patients with metastatic hormone-sensitive prostate cancer. Credit: PanuShot / Shutterstock.com.

Contracts

January 23, 2025

Kamada to supply immune globulin products in Latin America

KAMRAB must be administered alongside a complete rabies vaccine regimen. Credit: Nappy on Unsplash.

Bavarian Nordic secures $156.8m US vaccine deal

Boehringer Ingelheim receives EC conditional marketing approval for spesolimab

Marinus Pharmaceuticals signs collaboration agreement with Tenacia Biotechnology

Deals

Deals January 20, 2025

Fermion and Simcere to partner on development of pain treatment drug

Pharmaceutical Business Review

WuXi Biologics and Sino Biopharm collaborate on monoclonal antibody discovery

Merck enhances ophthalmology portfolio with EyeBio acquisition

Biocon signs licensing and supply deal for diabetes drug in Brazil

Popular

  1. CIRM unveils RAPID funding programme for rare diseases
  2. IQVIA and Boehringer Ingelheim collaborate on therapeutic data transformation
  3. Repertoire and Lilly join hands on autoimmune disease therapies
  4. Sensorion announces $71.9m reserved offering to expand gene therapy pipeline
  5. FDA grants breakthrough status to Biogen’s litifilimab for CLE

PRESS RELEASES

SCHOTT Pharma and SHL Medical Enhance Home-Based Large-Volume Injections for Patients
SCHOTT Pharma and SHL Medical Enhance Home-Based Large-Volume Injections for Patients
SCHOTT Pharma Launches Ready-to-Use Polymer Cartridge
SCHOTT Pharma Launches Ready-to-Use Polymer Cartridge
Accelerating Self-Administration and Homecare: SCHOTT Pharma Launches Large-Volume Prefillable Glass Syringe
Accelerating Self-Administration and Homecare: SCHOTT Pharma Launches Large-Volume Prefillable Glass Syringe
Pharmaceutical Business Review
Christian Mias to Succeed Andreas Reisse as CEO of SCHOTT Pharma
Pharmaceutical Business Review
LTS completes acquisition of Renaissance Lakewood, expanding global CDMO capabilities

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Whitepapers

Smoothly Through the Production Process: EVERIC™ Strong/Smooth Test
Smoothly Through the Production Process: EVERIC™ Strong/Smooth Test
Strengths and Weaknesses of Different Prefilled Syringes for Injections in Hospitals: A Case Study by Niklas Niederwieser and Patrick Gallagher SCHOTT AG
Strengths and Weaknesses of Different Prefilled Syringes for Injections in Hospitals: A Case Study by Niklas Niederwieser and Patrick Gallagher SCHOTT AG
Tracking the Cracking: How to Optimise Pharma Fill-and-Finish Processes by Use of Strength Testing and Fractography
Tracking the Cracking: How to Optimise Pharma Fill-and-Finish Processes by Use of Strength Testing and Fractography