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
Last week, Congress enacted the Consolidated Appropriations Act of 2026. This legislation narrows the scope of the statutory protection for drugs for rare diseases and conditions under the Orphan Drug Act, 21 U.S. Code §...more
As part of the recently enacted Consolidated Appropriations Act of 2026, Congress has reauthorized the Rare Pediatric Disease Priority Review Voucher (RPD PRV) program, long sought by the biopharmaceutical and life sciences...more
On Feb. 1, 2026, the FDA officially launched its Manufacturing PreCheck Pilot Program, which is intended to de-risk and accelerate the establishment of U.S. pharmaceutical manufacturing facilities by increasing regulatory...more
Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number of questions drug developers may have about the regulation and regulatory pathway...more
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
The US Food and Drug Administration (FDA) has approved a Phase 1 clinical trial from Life Biosciences that aims to help certain eye cells act younger and improve vision in glaucoma and related conditions....more
On January 30, 2026, the U.S. District Court for the District of New Jersey entered a Joint Stipulation of Dismissal resolving the pertuzumab BPCIA litigation between Genentech, Inc. and Hoffmann-La Roche Inc. (together,...more
On January 30, 2026, the Court ordered Genentech / Hoffmann-La Roche and Shanghai Henlius Biotech / Organon’s stipulated dismissal of Case No. 2:25-cv-14648 (D.N.J.) due to a settlement agreement between the parties. ...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
On January 21, 2026, as part of an earnings call, Dr. Reddy’s announced the filing of an aBLA for an intravenous (IV) formulation of DRL_AB (abatacept), a proposed biosimilar of Bristol-Myers Squibb’s Orencia® (abatacept) in...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
Many Prolia®/Xgeva® (denosumab) biosimilars approved in 2025 by FDA and EMA. FDA grants first interchangeable status for rapid acting insulin aspart, KristyTM....more
On Friday, the Supreme Court granted certiorari in Hikma Pharmaceuticals v. Amarin Pharma, ending an almost three-year lull in patent cases at the Court. The case presents two related questions, one framed specifically in the...more
On January 16, 2026, the U.S. Supreme Court agreed to hear Hikma Pharmaceuticals USA, Inc. v. Amarin Pharma, Inc., a patent dispute that could reshape the landscape of generic drug competition and patent enforcement....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 19, 2025, the FDA approved Amneal / mAbxience’s Boncresa™ / Oziltus™ (denosumab-mobz) as the nineth biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...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
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