FDA recently amended the emergency use authorization of Moderna's COVID-19 vaccine to allow for a second booster dose at the 50 microgram level in adults 50 years of age and older.
The...
FDA recently issued a complete response letter (CRL) for Eli Lilly and Company’s biologics license application (BLA) for its combination antibody therapy, sintilimab, to treat nonsquamous...
Pfizer and BioNTech recently submitted an application to FDA for emergency use authorization (EUA) of an additional COVID-19 vaccine booster dose for adults 65 years and older.
The...
Although there has been increasing public interest in studying scheduled drugs, most scientists are reluctant to conduct studies on Schedule I substances because of unreasonably burdensome rules and regulations enforced by the Drug...
FDA recently issued three final guidance documents to the industry regarding cancer clinical trials that parallel the goals of President Biden’s effort to renew and rebuild upon his 2016 Cancer...
FDA recently issued a complete response letter (CRL) to Gilead rejecting its New Drug Application (NDA) for HIV-1 treatment, lenacapavir.
The agency cited Chemistry Manufacturing and Controls (CMC)...
US Food and Drug Administration approval processes comprise numerous steps to ensure the safety and efficacy of new drugs, therapies, and treatments. Navigating the process can be complex and time-consuming, and as a result, the FDA is...
FDA recently accepted Bristol Myers Squibb’s supplemental Biologics License Application (sBLA) for its non-small cell lung cancer (NSCLC) drug, Opdivo, plus chemotherapy.
The agency based its...
FDA recently accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for Pfizer’s interchangeable biosimilar to Humira, Abrilada.
Abrilada is a...
Eli Lilly and Company recently launched an education campaign to educate, support, connect, and empower people diagnosed with early breast cancer (EBC) with a high risk of recurrence.
The campaign,...
Merck recently announced that Keytruda, combined with chemotherapy and followed by Keytruda as monotherapy, prolonged event-free survival compared to chemotherapy followed by placebo in patients with...
The Senate recently confirmed Robert Califf as FDA Commissioner after the Biden administration nominated him in early November, according to multiple outlets.
The final vote was 50 to 46, with six GOP...
The FDA recently issued draft guidance to foster the development of non-addictive alternatives to opioids to manage acute pain and prevent new addiction.
The guidance provides recommendations to...
Biogen recently exercised its option to participate in the development and commercialization of Genentech’s bispecific antibody, mosunetuzumab.
Mosunetuzumab is a CD20xCD3 T-cell engaging...
Pfizer and BioNTech recently initiated a rolling submission seeking to amend FDA’s emergency use authorization of their COVID-19 vaccine to include children six months to four years of age.
The...
FDA recently proposed a rule to provide greater assurance that supply chain participants are sufficiently qualified to distribute prescription drugs, strengthening the pharmaceutical supply chain.
The...
FDA recently accepted for review Regeneron’s biologics license application for its PD-1 inhibitor, Libtayo, in combination with chemotherapy to treat advanced non-small cell lung cancer...
FDA recently expedited approval of Gilead’s new drug application for its COVID-19 treatment, Veklury (remdesivir).
The agency expanded the drug to non-hospitalized adults and adolescent patients...
Pfizer recently announced positive top-line results from a Phase 3 trial studying its COVID-19 vaccine combined with its pneumococcal 20-valent conjugate vaccine, Prevnar 20.
The study, B74710126,...
