Here are the latest stories being discussed in biopharma today:

FDA Gives Green Light to Iovance’s Groundbreaking Melanoma Treatment

After more than 40 years in the making, Iovance Biotherapeutics’ therapy for advanced melanoma, Amtagvi, has received FDA approval. This marks the first modern cell therapy for a solid tumor, and not a blood cancer, to gain the FDA’s approval. Amtagvi is based on tumor-infiltrating lymphocytes or TILs – an approach in which immune cells penetrate and fight tumors. After numerous challenges of consistency across patients, Iovance is now ready to commercialize its new treatment.

Sarepta Awaits June for FDA Full Approval Decision

Despite Sarepta Therapeutics’ Duchenne gene therapy being mired in controversy and hiccups, it seems to be on course for an expansion of use. The FDA has set a June 21 deadline for decisions relating to expanded label and a conversion into full approval. Notably, Sarepta will not have to face an FDA advisory committee, and a positive outcome will mark a significant turn for the Duchenne patients and the rare disease gene therapy field.

FTC Push Leads GSK and Others to Delist Orange Book Patents

GSK and other companies have agreed to delist contentious patents following a push by the Federal Trade Commission (FTC) to address practices limiting competition. In the wake of the FTC crackdown, GSK has agreed to delist 12 of 14 identified patents, with Kaléo and Amneal, also delisting all patents challenged by FTC.

Roche and Novartis Receive Extended Label Approval by FDA

The FDA has given its approval for an expanded label for Roche and Novartis’ blockbuster Xolair (omalizumab). Based on a successful study funded by NIH, Xolair is granted approval for patients aged 1 year and older suffering from food allergies.

Organon’s Humira Biosimilar Secures Exclusive Spot on VA Formulary

Organon’s biosimilar Hadlima replaced AbbVie’s Humira on the US department of Veterans Affairs’s national formulary. This development grants Organon exclusive access to the VA’s formulary for the next five years, positioning them in a competitive position against other Humira biosimilars.

Senators Call for Prompt Updates for FDA Guidance on Prescription Drug Promotion

US Senators are calling for the FDA to update its current guidance on prescription drug promotion swiftly. They expressed concerns about the rise of misleading content related to prescription drugs on social media platforms.