FDA
Alexion shared the news that Ultomiris (ravulizumab-cwvz) has been approved by the FDA for commercialization, adding another indication for the precedent-setting drug.
FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
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Less than two weeks after Ginkgo Bioworks announced a merger with SPAC Soaring Eagle Acquisition Corp., it announced a collaboration partnership with Biogen.
Two of Merck’s Phase III pediatric trials show 15-valent pneumococcal conjugate vaccine, V114, may be safe and effective in healthy children.
Eli Lilly’s SURPASS-4 trial program shows tirzepatide, significantly reduced blood glucose levels and body weight better than insulin glargine in adult patients with type 2 diabetes.
The House Select Subcommittee on the Coronavirus Crisis questioned executives from Emergent BioSolutions as part of a congressional probe.
Shares of Voyager Therapeutics fell in aftermarket trading after its CEO and CMO announced plans to depart the company following clinical setbacks with a Parkinson’s disease program.
Several biopharmaceutical companies have submitted NDAs to the U.S. FDA covering treatment indications ranging from an opioid overdose, bipolar disorder and rare disease.
X-Vax Technology is ready to submit an IND application to the U.S. FDA for its experimental herpes vaccine against HSV-1 and -2. Here’s what you need to know.
The FDA further delays Iovance’s filing for its TIL therapy as it requests additional data on the treatment’s potency assays.
FDA says it is possible booster shots would be necessary for fully vaccinated individuals within a year even though vaccines are highly effective at COVID-19 prevention.
BMS inked a collaboration agreement with Exscientia that can leverage AI to speed the discovery of drug candidates in therapeutic areas, including oncology and immunology.