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Novo gets the green light for once-daily haemophilia drug following setbacks
Haemophilia is a rare condition that affects the blood’s ability to clot.
Tirzepatide Gets FDA Approval for Sleep Apnea in Adults With Obesity
Tirzepatide (Zepbound; Eli Lilly) is now approved for the treatment of moderate-to-severe obstructive sleep apnea (OSA) with obesity, the Food and Drug Administration announced late la...
Endo Recalls Adrenalin Chloride Solution
In a press release posted on FDA’s website, Endo USA, Inc. announced it was voluntarily recalling all lots of Adrenalin Chloride Solution (EPINEPHrine nasal solution, USP) 30 mg/30 mL (1...
FDA Awards Fast Track Designation to Staphylococcus aureus Vaccine Candidate
The FDA granted fast track designation (FTD) to a multivalent toxoid vaccine candidate from LimmaTech, LBT-SA7, which is designed to prevent skin and soft tissue infections (SSTIs) cau...
Mirroring Merck's problem, GSK's Jemperli-Zejula study in ovarian cancer misses survival goal
Two clinical trials by Merck and GSK both failed on their key secondary endpoints of overall survival in ovarian cancer. Perhaps PD-1 inhibitors just aren’t for ovarian cancer after all.
Aadi pulls commercial-to-preclinical pivot, buying ADCs and selling approved drug to reboot business
Aadi Bioscience has rebooted its operations, transforming from a commercial business into a preclinical biotech by offloading its approved product and licensing antibody-drug conjugates (ADCs)...
Novo commits $1.2B for new Danish facility
Ozempic maker Novo Nordisk A/S took two large steps toward meeting demand for its blockbuster drugs, committing $1.2 billion to build a new factory in Denmark shortly after it got the green light for ...
Astellas and Sangamo sign capsid deal for neurological diseases
Sangamo’s STAC-BBB is known for its ability to penetrate the blood-brain barrier and transduce neurons.
BioAge Labs announces collaboration with Novartis to target age-related diseases
BioAge Labs has announced a multi-year research collaboration with Novartis – this partnership aims to identify and validate novel therapeutic drug targets by exploring the biological mechanisms und...
Novo Holdings completes Catalent acquisition for $16.5bn
Novo Holdings has completed the previously announced acquisition of Catalent in a $16.5bn all-cash transaction. The European Commission (EC) gave its approval in early December 2024.
Trio of Indian drugmakers issue recalls tied to impurity, labeling issues
Indian drugmakers Aurobindo, Glenmark and Zydus have issued separate sweeping drug recalls over issues pertaining to impurities and labeling. The product pulls were reported in a recent edition of the...
Merck & Co. boosts GLP-1 portfolio by paying $112M upfront for Hansoh's preclinical drug
Merck & Co. has added a second GLP-1 candidate to its pipeline, paying China’s Hansoh Pharma $112 million upfront for a preclinical drug.
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