Alvotech Receives FDA Approval for New SIMLANDI® Manufacturing Process That More Than Doubles Output Per Batch

Enhanced process increases manufacturing productivity and frees up capacity to support growing demand across Alvotech’s ...
BioSpace

New FDA draft guidance doubles down on expediting approvals of personalized gene therapies

The FDA has outlined a process for allowing a single application to cover multiple variants of a gene therapy. At the same ...

Alvotech Shares Rise After FDA Okays Simlandi Manufacturing Process

Alvotech shares rose after the company said the Food and Drug Administration approved a new manufacturing process for Simlandi, its biosimilar to Humira. The stock was 8% higher, at $5.41, in morning ...

Alvotech shares jump premarket after FDA approves new Simlandi process

Alvotech shares rose more than 6% in premarket trading Tuesday after the U.S. Food and Drug Administration approved a new manufacturing process for Simlandi, the company’s biosimilar to Humira.
ALS News Today

Clene seeks FDA accelerated approval of oral ALS treatment

Clene Nanomedicine has submitted an application to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of its experimental oral therapy CNM-Au8 for people with amyotrophic lateral ...

New anti-HSV drug Pritelivir receives FDA approval: An 'oral treatment' option for existing drug-resistant herpes; note the differences in development and marketing c…

The target population is adult immunocompromised patients with HSV mucocutaneous lesions that are refractory to treatment ...
Medical Daily

Psilocybin Could Become the First FDA-Approved Psychedelic Therapy Within Months — Here Is What Patients Need to Know

A CHQPR analysis identifies 84 Texas rural hospitals at risk of closing, including 26 facing immediate risk, potentially putting emergency, maternity and inpatient services farther away. Harkla ...
Collinsville Daily News on MSN

Beyond the peptide hype: Which treatments have FDA approval?

GoodRx reports that FDA-approved peptides have undergone safety and effectiveness testing, while unapproved wellness peptides ...

FDA conditionally approves AstraZeneca's rare kidney disease drug

The U.S. Food and Drug Administration (FDA) on Thursday granted accelerated approval to AstraZeneca Plc’s AZN Ultomiris ...

Alvotech S.A.: Alvotech receives FDA approval for new SIMLANDI manufacturing process that more than doubles output per batch

Enhanced process increases manufacturing productivity and frees up capacity to support growing demand across Alvotech's biosimilars portfolio REYKJAVIK, Iceland and LONDON, UK (October 20, 2026) - Alv ...