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Press Releases
Merck’s WELIREG® (belzutifan) Approved in China for the Treatment of Adult Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors
November 22, 2024
·
14 min read
Press Releases
Faeth Therapeutics Appoints Dr. Stephen Hahn and Dr. Jayson Dallas to Board of Directors
November 22, 2024
·
2 min read
Press Releases
Merck to Participate in the 7th Annual Evercore ISI HealthCONx Conference
November 22, 2024
·
3 min read
Press Releases
ENDRA Life Sciences Regains Compliance with Nasdaq Minimum Bid Price Requirement
November 22, 2024
·
3 min read
Press Releases
Novotech Publishes Comprehensive Report on the Global Vaccine Clinical Trials Landscape
November 22, 2024
·
2 min read
Press Releases
Savara Announces Encore Presentation of Results from the Phase 3 IMPALA-2 Trial of Molgramostim Inhalation Solution (Molgramostim) in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the British Thoracic Society Winter Meeting 2024
November 22, 2024
·
2 min read
FDA Tracker
Amneal Wins FDA Nod for GLP-1 Generic
In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as
BioSpace
keeps you up to date on all of the FDA’s decisions in 2024.
November 22, 2024
·
205 min read
·
Heather McKenzie
Gene therapy
Patient Death in Rett Syndrome Trial Forces Neurogene to Drop High-Dose Arm
Despite the death, the FDA has allowed Neurogene to forge ahead with the Phase I/II Rett syndrome trial, but using only the lower 1E15 vg dose of its investigational gene therapy NGN-401.
November 22, 2024
·
2 min read
·
Tristan Manalac
Adcomms
AstraZeneca Fends Off Adcomm’s Safety Concerns on Andexxa, Axes Mid-Stage Opioid Use Disorder Drug
The pharma is seeking full approval for its anticoagulation reversal drug Andexxa, which the FDA granted accelerated approval in 2018 for patients who had been treated with apixaban or rivaroxaban.
November 22, 2024
·
3 min read
·
Tristan Manalac
Drug shortages
FDA Still Undecided About Shortage Status of Lilly’s Tirzepatide
Pending the FDA’s decision, compounding pharmacies will remain free to make and market versions of the blockbuster weight-loss therapy.
November 22, 2024
·
2 min read
·
Tristan Manalac
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