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Latest From Sanofi
Rezafungin Review Highlights US FDA’s ‘Flexible Development' Approach For Antimicrobials
Cidara developed the antifungal for candidemia/invasive candidiasis pursuant to the FDA’s 2017 ‘Unmet Need guidance,’ which provides an avenue for approval with a 'limited use' indication based on a streamlined development program. Some of the guidance recommendations also have been leveraged under the LPAD pathway.
EMA Says Yes To BMS’ Sotyktu But Turns Down Ipsen’s Sohonos
The European Medicines Agency has recommended pan-EU marketing approval for four medicines but turned down Ipsen’s treatment for an ultra-rare bone disorder. It has also OK’d new uses of seven already-approved drugs and is reviewing efficacy concerns regarding Novartis’ sickle cell medicine.
Scrip Asks…What Does 2023 Hold For Biopharma? Part 5: Technological Advances
The confluence of data science and molecular biology fuels expectations among biopharma industry leaders for another year of breakthrough innovation in human therapeutics. More than 70 executives and experts reveal what they are most excited about on the technology front.
US FDA Still Not Scheduling In-Person Meetings Despite Sponsor Requests
Some sponsors appear to be growing antsy to meet with agency staff and advisory committees in-person, but CDER continues to schedule only virtual meetings.
Company Information
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- Pharmaceuticals
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Pharmaceuticals
- Specialty Pharmaceuticals
- Vaccines
- Other Names / Subsidiaries
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- Ablynx N.V.
- Acambis PLC
- Avigen Inc.
- Bioverativ Inc. (True North Therapeutics, Inc.)
- BiPar Sciences Inc.
- BMP Sunstone Corporation
- Canderm Pharma Inc.
- Celmed BioSciences, Inc.
- Chattem, Inc.
- Connaught Laboratories Ltd.
- Fisons Ltd.
- Fovea Pharmaceuticals, SA
- Genfar S.A.
- Genzyme Corporation
- Groupe Sanofi
- Hoechst Marion Roussel
- Kadmon Holdings, Inc.
- Kiadis Pharma B.V.
- Kiadis Pharma N.V.
- Pluromed
- Principia Biopharma Inc. Protein Sciences Corporation
- Rhone-Poulenc Rorer
- Sanofi-Aventis
- Sanofi-aventis Groupe
- Sanofi Pasteur MSD
- Shantha
- Synthorx, Inc. (THOR)
- TargeGen, Inc.
- Thunder Acquisition
- Tidal Therapeutics
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