Topic
FDA Approval
200 published works
Drug & Device Law
MDL Court: Pre-Approval Design-Defect Claim Not Preempted
In a ruling that is contrary to Supreme Court precedent, the district court presiding over the Zostavax MDL recently held that federal law does not preempt a state-law design-defect claim…
DC Medical Malpractice & Patient Safety Blog
FDA under renewed fire over dubious approval of Alzheimer’s drug
Taxpayers and patients are suffering the rising negative consequences of the federal Food and Drug Administration’s dubious decision to overrule its own independent expert advisors and to approve on scant…
Big Molecule Watch
Coherus and Junshi Biosciences Announce FDA Acceptance of Toripalimab BLA
By James Breen
Last week, Coherus and Junshi Biosciences announced that the FDA accepted their BLA for toripalimab in combination with gemcitabine and cisplatin for the first-line treatment of patients with advanced recurrent…
Health Law Prof Blog
Regulatory Reactivity in FDA’s Approval of the Alzheimer’s Disease Drug Aducanumab (Aduhelm)
Yaniv Heled (Georgia State University), Ana Santos Rutschman (Saint Louis University), Liza Vertinsky (Emory University), Regulatory Reactivity in FDA's Approval of the Alzheimer's Disease Drug Aducanumab (Aduhelm), Regul. Rev. (2021):On…
Big Molecule Watch
FDA Approves Interchangeable Status for BI’s Adalimumab Biosimilar Cyltezo
BI’s adalimumab biosimilar CYLTEZO (adalimumab-adbm) has recently been granted interchangeable status by the FDA. Although approved in August 2017, CYLTEZO is not scheduled to launch until July 1, 2023, pursuant…
Big Molecule Watch
CHMP adopts positive opinion on Alvotech’s adalimumab biosimilar
By Huiya Wu
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Alvotech‘s high-concentration AVT02 (100 mg/mL), a proposed biosimilar to Humira® (adalimumab). Humira® is…
Big Molecule Watch
Enzene Biosciences Announced Romiplostim Approval in India
By Alexandra Valenti|Joshua Weinger
Last week, Enzene Biosciences announced that it has received marketing authorization from the Drug Controller General of India (DCGI) for its biosimilar product romiplostim. The product will be offered in…
Canna Law Blog
MDMA and the FDA Approval Process
By Ethan Minkin
Excitement abounds about the status of MDMA, otherwise known as Ecstasy. And for good reason. As noted last month in the New York Times: …those who received MDMA during therapy…
Canna Law Blog
MDMA (Ecstasy) Nears FDA Approval for PTSD Treatment
By Andrew Smith
Efforts by the Multidisciplinary Association for Psychedelic Studies (MAPS) to legalize prescription MDMA (Ecstasy) appear to have passed a gigantic hurdle earlier this month: MDMA is on track to meet…
Big Molecule Watch
Lannett Receives FDA Feedback Regarding Insulin Glargine Biosimilar
By Grace Truong|Big Molecule Watch
Lannett Receives FDA Feedback Regarding Insulin Glargine Biosimilar On March 10, Lannett announced that it received feedback from the FDA regarding its insulin glargine biosimilar. Lannett sought and received comments…