Drugs
Drug companies that operate in both the U.S. and the European Union (EU) should treat supply chain strategy as a core regulatory function and not an afterthought. That’s the key takeaway from attorney Winston Kirton (Baker Hostetler) in a recent Regulatory Horizons podcast on how regulatory practices in
Drugs
An online Clinical Trial Vanguard post says FDA has not kept pace with the advancing science of oncology-based basket trials migrating into non-oncology drug trials. “FDA’s guidance on master protocols, covering basket, umbrella, and platform trials, was finalized in 2022 and is explicitly anchored to oncology use
Drugs
FDA has lifted a partial clinical hold against MacroGenics’ Phase 2 LINNET study evaluating the investigational cancer therapy lorigerlimab, allowing the company to resume patient enrollment. The hold had previously paused the addition of new participants, though patients already enrolled were permitted to continue receiving treatment. With the restriction lifted,
Drugs
While individualized and shortage drug compounding are necessary exceptions to FDA standards, mass compounding of commercially available drugs is not. That’s the view of FDA Matters founder Steven Grossman and Nancy Glick, director of food and nutrition policy at the National Consumers League. In an FDA Matters column, the
Drugs
FDA has announced a two-day public workshop next month aimed at improving how pregnancy registries are designed and used to assess the safety of drugs and biologics during pregnancy. The 5/7-8 workshop is part of a broader effort to strengthen the generation of high-quality human safety
Drugs
A coalition of 20 healthcare, consumer, and policy organizations is calling on key House lawmakers to hold hearings and advance bipartisan legislation aimed at lowering prescription drug costs by curbing patent practices and preserving generic competition. In a 4/6 letter to Jim Jordan (R-OH), chairman of the House
Drugs
FDA has accepted an Outlook Therapeutics formal dispute resolution request (FDRR) regarding the agency’s prior rejection of eye disease therapy ONS-5010/Lytenava (bevacizumab-vikg), setting up a high-stakes meeting later this month. The dispute stems from a December complete response letter (CRL) on the company’s BLA
Drugs
A federal judge 4/7 declined to immediately restrict access to the abortion pill mifepristone, instead pausing a high-profile lawsuit brought by Louisiana and allowing current nationwide access — including distribution by mail — to continue for now. In a ruling that temporarily favors the status quo, U.S. district judge
Drugs
The National Organization for Rare Disorders (NORD) says that as FDA considers what rare disease resources to share and in what format, it should tailor materials towards both developers and patients, so patients can be educated about productive ways to engage in the product development process. The NORD comment came
Drugs
ImmunityBio says it has responded to FDA’s recent Warning Letter on the company’s alleged misleading promotional claims about its cancer therapy Anktiva (nogapendekin alfa inbakicept-pmln) in both a television advertisement and a podcast appearance by company leadership (see earlier story). The company says it is taking steps
Drugs
FDA’s new draft guidance outlining, for the first time, formal expectations for how drug manufacturers should respond to Form FDA 483 observations following inspections of current GMP compliance appears to be raising the compliance bar. According to a Cooley legal alert, some aspects of the guidance seem to go
Drugs
FDA says beginning 10/1 it will require drugmakers and other regulated entities to adopt updated international data standards for submitting postmarketing safety reports, according to a notice scheduled for publication in the Federal Register. The requirement applies to individual case safety reports (ICSRs) for human drugs, biologics and certain
Drugs
FDA has granted Context Therapeutics a fast-track designation for its experimental therapy CTIM-76 for treating platinum-resistant ovarian cancer, a difficult-to-treat form of the disease with limited options. CTIM-76 is described as a T cell–engaging bispecific antibody designed to target CLDN6-positive tumors by
Drugs
In a 4/1 letter to two FDA senior officials, FDA commissioner Marty Makary says the agency does not intend to enforce two sections of the Federal Food, Drug, and Cosmetic Act involving adequate directions for use and new drug approvals with respect to an orally administered, hemp-derived CBD
Drugs
(Editor's note: Late on 4/2, the White House released a Fact Sheet about the tariffs.) President Trump is reportedly preparing to impose sweeping new tariffs on certain pharmaceutical imports, targeting companies that have not agreed to participate in his administration’s “Most Favored Nation” (MFN) drug pricing
Drugs
A bipartisan pair of senators is pressing FDA to take a more proactive role in policing prescription drug advertising, citing a surge in misleading direct-to-consumer promotions — for weight-loss treatments. In a letter sent this week, Dick Durbin (D-IL), the Senate Democratic Whip, and Roger Marshall (R-
Drugs
The Rare Disease Advocacy, Biotechnology, and Investor Coalition, which has nearly 100 rare disease patient advocacy groups, biotechnology executives, and investors as members, is urging the Trump administration to use the appointment of a new CBER director to restore regulatory clarity for rare diseases. The new appointee will replace Vinay
Drugs
A 4/29-5/9/2025 FDA inspection at the LeeSar drug outsourcing facility in Fort Myers, FL, found multiple violations in the firm’s production of compounded drugs. A just-released 11/21/2025 Untitled Letter lists these violations: * failure to meet the conditions of Section 503B, such as
Drugs
A three-judge panel of the 5th Circuit Court of Appeals heard oral arguments on 3/30 in a challenge to FDA’s finding that popular weight loss drugs are no longer in short supply and thus cannot be legally compounded except in very restricted circumstances. Courthouse News Service reports
Drugs
FDA is prioritizing efforts to accelerate drug development timelines beginning at the investigational new drug (IND) stage, while also pushing to expand over-the-counter (OTC) access and modernize regulatory processes, commissioner Marty Makary said Wednesday. Speaking during a press briefing, Makary emphasized that the agency is rethinking the full
Drugs
FDA has extended by three months its review of an Orca Bio BLA for its experimental cell therapy Orca-T, pushing the agency’s decision deadline to 7/6. The submission is seeking approval for the therapy to treat a range of hematologic malignancies, including acute leukemias and myelodysplastic syndromes.
Drugs
FDA has approved Eli Lilly’s Foundayo (orforglipron), a once-daily oral treatment for adults with obesity or those who are overweight with related health conditions. The approval marks Lilly’s second authorized obesity medicine, joining weekly injectable Zepbound (tirzepatide), and introduces a pill-based alternative in a market largely