Regulatory

Between 2026 and 2030, billions of dollars in revenue will be at risk due to expiring patents and periods of exclusivity.

The former lead counsel discusses FDA’s efforts to bring about strict oversight on DTC drug ads and the difficulties the agency faces in doing so.

FDA approves Shionogi’s Xocova as First Oral Post-Exposure Covid-19 Prevention Therapy, marking a major milestone for Covid-19 prevention treatments.

As FDA complete response letters continue to impact nearly half of cell and gene therapy submissions, manufacturing strategy and process design are emerging as the industry’s most persistent regulatory vulnerabilities.

FDA advisors are set to meet this week to determine whether Covid-19 vaccines should be updated to target the emerging XFG variant, a decision that could shape the composition of the 2026–2027 immunization season amid ongoing viral evolution.

Harpreet Singh, former FDA Oncology Division Director and current chief medical officer at Precision for Medicine notes how evolving FDA review standards, expedited approval programs, and emerging AI tools are reshaping the regulatory landscape for biopharma companies.

FDA approves Gilead’s Hepcludex as the first treatment for chronic hepatitis delta virus in the U.S., marking a major milestone for a severe liver disease with limited therapeutic options.

FDA approves AstraZeneca and Daiichi Sankyo’s Datroway for first-line metastatic triple-negative breast cancer, expanding treatment options for patients ineligible for PD-1/PD-L1 inhibitor therapy.

Jeffrey Taubenberger’s departure was announced by Senator Baldwin during a congressional hearing.

MedicNova’s chief business officer details how changes at FDA are causing tension with the industry and investors, who are finding themselves less confident in the regulatory process.

Investors seeking predictability are adjusting their strategies in the current regulatory environment.

FDA undergoes leadership upheaval, leaving key drug and biologics divisions under interim control and raising concerns over regulatory continuity amid turnover at the agency’s highest levels.

FDA approved Baxfendy for adults with uncontrolled hypertension, introducing a new drug class in a large and competitive market.

FDA expanded Enhertu (trastuzumab deruxtecan) use in early HER2-positive breast cancer based on phase 3 neoadjuvant and adjuvant trial data.

Dr. Richard Graham explains how FDA’s new program allows for the usage of real-time data during clinical trials.

Author Jeremy Levin discusses how various factors are impacting the biotech industry in a negative way by pushing investment and politics over science.

David Crean, chief business officer at MedicNova, discusses changes at FDA causing variability and unpredictability in regulatory approvals.

FDA approved AstraZeneca’s Fasenra for hypereosinophilic syndrome in patients aged 12 and older, expanding the IL-5 receptor-targeting therapy into a third eosinophil-driven disease with limited treatment options.

FDA has approved BeOne Medicines’ Beqalzi for relapsed or refractory mantle cell lymphoma and Taiho Oncology’s Inqovi plus venetoclax for newly diagnosed acute myeloid leukemia, expanding treatment options for patients with difficult-to-treat blood cancers.

Dr. Jeremy Levin explains how the current media environment allows for misinformation spread, and the impact it has on trust in medicine.

Dr. Jeremy Levin discusses the importance of relying on scientific fact to make decisions in biotech research.

Reports also claim that Kyle Diamantas will serve as acting head of FDA.

FDA has approved Partner Therapeutics’ Bizengri for NRG1 fusion-positive cholangiocarcinoma, expanding precision oncology options for a rare subset of gastrointestinal cancer patients with limited targeted treatment alternatives.

FDA extended its review of Leqembi’s once-weekly subcutaneous starting dose for early Alzheimer’s disease by three months after requesting additional information from Eisai and Biogen.