News
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
FEATURED STORIES
Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
Thanksgiving week was marked by numerous clinical trial announcements. Here’s a look.
The U.S. Food and Drug Administration has a very busy calendar for the end of November and beginning of December. Here’s a look.
Bonus BioGroup’s product is back in the news again as its cell therapy promises to treat late-stage COVID-19.
Both Gilead Sciences and Merck announced they were pausing a Phase II trial of islatravir and lenacapavir in HIV.
A cardiovascular drug Pfizer licensed from Akcea Therapeutics in 2019 hit the mark in a Phase IIb dose-ranging study in patients with elevated non-HDL-C and triglycerides.
Although vaccines and effective therapeutics are powerful tools in preventing and treating COVID-19, we’re not done battling the disease just yet. For those stories and more, read on.
The precision medicine company is developing mutant selective and isoform-specific drugs in non-conventional ways for well-known targets in the oncology and autoimmune spaces.
Shares of Kura Oncology have plunged nearly 30% in premarket trading after the FDA placed a partial clinical hold on the company’s Phase Ib leukemia study following the report of a patient’s death.
The FDA approved Takeda’s Livtencity (maribavir) for adults and children 12 years or older with post-transplant cytomegalovirus (CMV) infection.
Plenty to be thankful for this week for these biopharma companies, especially with the influx of cash.