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)...
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...
GSK recently announced that the consumer healthcare company from its proposed transaction with Pfizer will be named Haleon.
Haleon will be a new world leader in consumer healthcare, offering to bring...
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,...
Bristol Myers Squibb recently granted $7.965 million to 24 US non-profit organizations to improve access to care for medically underserved patients across oncology, cardiology, immunology, and...
Samsung Biologics will acquire Biogen’s stake in Samsung Bioepis for $2.3 billion to accelerate growth in biosimilars and novel therapeutic research and development.
Under the terms of the...
FDA recently approved Takeda Pharmaceutical’sPharmaceutical’s Vonvendi for routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand...
Patient factors, including Medicaid or Medicare Advantage, comorbid substance use disorder, medical comorbidities, and prescription-related factors, are associated with opioid overdose, according to a...
FDA recently approved an update to the prescribing information for Kite’s Yescarta to include prophylactic corticosteroids across all approved indications.
The agency first approved Yescarta in...
Pfizer recently announced that it will appoint William Pao, MD, PhD, as executive vice president and chief development officer.
Effective March 2022, Pao will replace Rod Mackenzie, who recently...
Eli Lilly and Company recently announced plans to invest over $1 billion to create a new manufacturing site and boost access to medicine in Concord, North Carolina.
The facility will utilize 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...
Cosette Pharmaceuticals recently acquired US sales and distribution rights to eight prescription medications from Daiichi Sankyo Company and its affiliates.
Under the 30-month transition agreement,...
FDA recently approved new expanded magnetic resonance imaging (MRI) compatibility for Abbott’s Proclaim XR Spinal Cord Stimulation (SCS) System with Octrode Leads.
The Proclaim XR SCS System is...
FDA recently granted emergency use authorization for Siemens Healthineers’ CLINITEST Rapid COVID-19 Antigen Self-Test.
The nasal swab test is a point-of-care cassette test that does not require...
FDA recently approved two pediatric indications for Johnson & Johnson’s direct oral anticoagulant (DOAC), Xarelto.
The agency approved the drug to treat venous thromboembolism (VTE) and to...
Biogen recently announced that it will reduce the wholesale acquisition cost (WAC) of its Alzheimer’s disease treatment, Aduhelm, in the US by nearly 50 percent.
For a patient of average weight,...
