Alvotech and Dr. Reddy’s gets FDA nod for Biologic License Application for AVT03
Dr. Reddy’s Laboratories (RDY) and Alvotech (ALVO) announced that the U.S. FDA has accepted a Biologic License Application submission for AVT03. Read more here.
Travere Therapeutics Submits sNDA to FDA for Approval of FILSPARI® (sparsentan) for the Treatment of FSGS
NDA submission based on results from Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI in FSGSIf approved, FILSPARI could become the first and ...
Travere Therapeutics submits sNDA to FDA for approval of FILSPARI in FSGS
Travere Therapeutics (TVTX) has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration seeking priority review ...
Science Daily3d
Re-purposed FDA-approved drug could help treat high-grade glioma
A study shows that high-grade glioma tumor cells harboring DNA alterations in the gene PDGFRA responded to the drug avapritinib, which is already approved by the United States Food and Drug ...
CBS News19d
FDA cancels meeting to update next season's flu vaccines
It's an important meeting. What's the plan for flu vaccines this year," Dr. Paul Offit, a member of the FDA advisory committee and director of the Vaccine Education Center at Children's Hospital ...
FiercePharma21d
FDA dings Piramal API plant with Form 483 detailing problems tied to quality control, equipment cleaning and more
Following an inspection of Piramal’s production facility in Maharashtra, India, that ran from Feb. 11 to Feb. 17, the FDA slapped the company with six-observation Form 483 detailing shortfalls ...
ndtvprofit21d
Gland Pharma Gets Three FDA Observations For Visakhapatnam Facility
Gland Pharma Ltd. said on Tuesday that the US Food and Drug Administration has issued a Form 483 with three observations to its facility in Visakhapatnam. According to the company’s exchange filing, ...
CNN21d
FDA meeting to choose flu vaccine composition canceled without explanation
What’s the plan?” he said. The FDA confirmed the cancellation in a statement sent to CNN on Thursday. “A planned March 13 meeting of the FDA’s Vaccines and Related Biological Products ...
ADVFN21d
Form S-3ASR - Automatic shelf registration statement of securities of well-known seasoned issuers
If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box. ☐ If any of the securities being ...
CNN22d
FDA delays when a final rule on what foods can be labeled as ‘healthy’ goes into effect
In December, the FDA finalized a rule that updates the nutritional requirements a human food item must meet to claim on its packaging that it is “healthy.” That rule was published with an ...
Associated Press22d
FDA moves to rehire medical device, food safety and other staffers fired days earlier
Beginning Friday night, FDA employees overseeing medical devices, food ingredients and other key areas received calls and emails notifying them that their recent terminations had been “rescinded ...
The New York Times26d
F.D.A. Firings Decimated Teams Reviewing A.I. and Food Safety
Staff units evaluating high-tech surgical robots and insulin-delivery systems were gutted by Trump layoffs even though industry fees, not taxpayers, financed the employee salaries. By Christina ...