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On February 8, 2023, Regeneron announced that the FDA approved its EYLEA® (aflibercept) injection for the treatment of retinopathy of prematurity (ROP) in preterm infants

On October 20, 2025, the FDA approved Genentech's GAZYVA® (obinutuzumab) as a treatment for adults with lupus nephritis (LN).

On October 27, Coherus BioSciences, Inc. and Shanghai Junshi Biosciences Co., Ltd. announced that the U.S. Food and Drug Administration approved LOQTORZI (toripalimab-tpzi)...

Explore the latest regulatory approvals, biosimilar launches, and patent settlements shaping the biologics market. From FDA approvals of groundbreaking gene therapies to strategic acquisitions and BPCIA litigation updates, discover how innovation and competition are transforming treatment access across oncology, immunology, and rare diseases.

FDA issued a final rule amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of feed-grade sodium formate as a feed-acidifying agent...

In the September 15, 2015, Federal Register, FDA announced it is implementing its authority to destroy a drug valued at $2,500 or less.

FDA and the U.S. Customs and Border Protection collaborated to crack down on websites and distributors marketing unapproved prescription drugs.

In the February 6, 2015, Federal Register, FDA announced it will continue CDER's Regulatory Project Management Site Tours and Regulatory Interaction Program.

FDA clarifies and confirms that the compliance date for the final rule is May 5, 2017.

In the December 23, 2014, Federal Register, FDA clarified its policy regarding certain aspects of orphan-drug exclusivity due to a recent court decision interpreting provisions of the Food Drug and Cosmetic Act...

In the February 26, 2015, Federal Register, FDA classified the Assisted Reproduction Embryo Image Assessment System into class II (special controls).

The order identifies the special controls for this type of medical device, which will be included in its classification regulation.

FDA issued a final rule confirming the November 2, 2015, effective date for the final rule amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments.

In the October 13, 2015, Federal Register, FDA confirmed the effectiveness of the final rule, published on June 23, 2015, that amended the regulations on nutrient specifications and infant formula labelling...

In the January 22 and January 25, 2016, Federal Registers, FDA corrected and amended a final rule published in the September 17, 2015, Federal Register amending the regulation for CGMPs in manufacturing...

In the August 14, 2014, Federal Register, FDA corrected a final rule entitled "Postmarketing Safety Reports for Human Drug and Biological Products.

In the August 27, 2015, Federal Register, FDA published its determination that Biaxin XL were not withdrawn from sale for reasons of safety or effectiveness.

Since the last Jones Day Update, FDA determined that JADELLE (levonorgestrel) Implant, 75mg was not withdrawn for reasons of safety or effectiveness.