Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Podcast | Episode 104: Dr. Nicholas Vafai, Founder and President, Viro Research
DE Talk | Navigating COVID-19 Vaccine Mandates: Employer vs Employee Rights
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
What device companies need to know ahead of an advisory panel meeting
Consistent with the Food and Drug Administration’s (FDA) commitment to streamlining the prescription drug and biologics approval processes by adopting innovative approaches to clinical trial design, the agency recently...more
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
On January 13, 2026, Shanghai Henlius Biotech announced the FDA acceptance of an aBLA for HLX04, its proposed biosimilar of Genentech’s Avastin® (bevacizumab). ...more
This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more
In the first year of the second Trump administration, we have seen the Food and Drug Administration (FDA) take an unprecedented role in drug pricing policy....more
On January 19, 2026, Hikma announced the launch of Enoby™ / Xtrenbo™ (denosumab-qbde), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab), following their FDA-approval in September 2025. ...more
On December 18, 2025, the FDA approved Formycon and Zydus’s Nufymco™ (ranibizumab-leyk) as the third interchangeable biosimilar of Genentech’s Lucentis® (ranibizumab). Lucentis® biosimilars have been on the market since July...more
On December 22, 2025, the FDA approved mAbxience and Amneal’s Biologics Licensing Applications (BLAs) for BONCRESA™ (denosumab-mobz) and OZILTUS™ (denosumab-mobz), biosimilars referencing Amgen’s PROLIA® (denosumab) and...more
On December 3, 2025, Celltrion announced that the FDA has approved a new dose of OMLYCLO (omalizumab-igec), the first and only biosimilar designated as interchangeable with Genentech and Novartis’s XOLAIR (omalizumab). The...more
The U.S. Food and Drug Administration (FDA) has approved a significant update to the prescribing information for Depo-Provera, adding a warning about a potential association with meningiomas, a type of brain tumor. This marks...more
On June 17, 2025, FDA Commissioner Marty Makary launched a new priority review pilot program intended to accelerate FDA review for drug and biologic companies supporting U.S. national interests. Specifically, the...more
In 1995, the Michigan Legislature enacted its Drug Immunity Law, which provided an absolute defense for pharmaceutical companies in product liability suits stemming from the safety and efficacy of their drug products, the...more
On December 4, 2025, the FDA approved a new indication for Bristol Myer Squibb’s BREYANZI (lisocabtagene maraleucel) for the treatment of adults with marginal zone lymphoma (MZL) who have failed treatment with or relapsed...more
On November 20, 2025, the FDA approved Accord’s Osvyrti® and Jubereq® (denosumab-desu), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more
Lupin Limited announced on December 1 that it received FDA approval for its biosimilar product, ARMLUPEG (pegfilgrastim-unne). ARMLUPEG is approved as a 6 mg/0.6 mL single-dose prefilled syringe presentation, referencing...more
On November 17, 2025, Sandoz and Polpharma announced the U.S. launch of Tyruko® (natalizumab-sztn), the first and only FDA-approved biosimilar to Biogen’s Tysabri® (natalizumab) and the first biosimilar available to treat...more
On November 17, 2025, Sandoz announced the launch of TYRUKO® (natalizumab-sztn) in the United States as the first and only biosimilar for the treatment of relapsing forms of multiple sclerosis. TYRUKO® was approved by FDA in...more
On November 20, 2025, the FDA approved Accord BioPharma’s denosumab biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), which reference Amgen’s PROLIA® and XGEVA®, respectively. This marks the eighth set of...more
On November 11, 2025, Sanofi and Regeneron announced that the FDA accepted for priority review its supplemental biologics license application (“sBLA”) for Dupixent (dupilumab) in the treatment of adults and children aged 6...more
The Food and Drug Administration (FDA) has issued a statement, published electronically in the New England Journal of Medicine (NEJM) on November 12, 2025, proposing a new process for obtaining marketing authorization for...more
On November 7, Vera Therapeutics announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) through the Accelerated Approval Program for atacicept for the treatment of...more
In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and in some cases...more
On November 6, 2025, Hikma Pharmaceuticals PLC, and its subsidiary Hikma Pharmaceuticals USA Inc., announced the launch of STARJEMZA (ustekinumab-hmny). STARJEMZA references Janssen’s STELARA, and is indicated for the...more
On October 20, 2025, the FDA approved Genentech’s GAZYVA® (obinutuzumab) as a treatment for adults with lupus nephritis (LN). Gazyva is a type II humanized anti-CD20 monoclonal antibody that works by targeting and eliminating...more