It’s not often that disclosure of a complete response letter (CRL) causes a company’s share price to rise, but that was case for Aquestive Therapeutics Inc., which saw its stock (NASDAQ:AQST) rise 39% to close Feb. 2 at $4.10 on news the U.S. FDA has declined – for now – to approve the NDA for Anaphylm (dibutepinephrine), delaying the commercial entry of what could be the first oral alternative to Epipen.

Trace Biosciences Inc. has obtained IND approval from the FDA for LGW16-03 (Nervetrace Dx), the company’s first nerve-specific fluorescent imaging agent. The IND clearance enables Trace to initiate a first-in-human study evaluating the safety and intraoperative performance of LGW16-03 in surgical settings.

Elevar Therapeutics Inc. appointed Kim Dong-gun (DG) as CEO Jan. 29, as the company focuses on post-NDA strategies for lirafugratinib in bile duct cancer, and the twice-rejected rivoceranib-camrelizumab combination for liver cancer.

The EMA has started a review of Amgen Inc.’s Tavneos (avacopan) after questions were raised about the integrity of the data in the Advocate study that the agency assessed when granting approval of the vasculitis treatment in January 2022.

A new draft guidance for organ procurement organizations doing business in the U.S. would seem to tackle some pressing issues with organ donation, such as the conditions in which a problem qualifies as an adverse event. Perhaps of greater interest to companies in the organ container business is that the Centers for Medicare & Medicaid Services is intent on increasing the availability of organ donations to deal with an insatiable demand for donated organs.

For years, Japan’s “drug lag” was shorthand for slow regulatory reviews and delayed approvals compared with the U.S. and Europe. But even as regulatory timelines have shortened, review capacity has expanded and international alignment has improved, Japanese patients still face gaps in access to innovative drugs.

The presbyopia space gained another player as Tenpoint Therapeutics Ltd. won the U.S. FDA’s go-ahead for Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution, 2.75%/0.1%, previously known as Brimochol PF), the first and only dual-agent eye drop for the treatment of adult presbyopia.