Amino Acid, Peptide, or Protein
CDC Advisors Shift COVID-19 Vaccine Guidance to Individual Decision-Making
CDC; COVID-19 vaccine; vaccine recommendation; individual choice; ACIP; provider consultation
FDA Approves Stealth BioTherapeutics’ Forzinity as First Treatment for Barth Syndrome After Rejection and Delay
FDA approval; Stealth BioTherapeutics; Forzinity; elamipretide; Barth syndrome; rare disease; mitochondrial dysfunction; accelerated approval
FDA Grants Accelerated Approval to Stealth BioTherapeutics’ Forzinity, the First Treatment for Barth Syndrome
FDA approval; Stealth BioTherapeutics; Forzinity; elamipretide; Barth syndrome; mitochondrial disease; accelerated approval; rare disease; pediatric disease; clinical trial
Merck Wins FDA Approval for Subcutaneous Keytruda as Exclusivity Challenges Approach
Merck; Keytruda; subcutaneous injection; FDA approval; Keytruda Qlex; patent expiration; biosimilars; checkpoint inhibitors; solid tumors; cancer immunotherapy
ACIP Vote Restricts Combined MMRV Vaccine for Children Under 4, Raising Access Concerns
ACIP; MMRV vaccine; measles; mumps; rubella; varicella; childhood immunization; Vaccines for Children (VFC) program; CDC vaccine recommendation; vaccine access
Novo Nordisk Awaits FDA Decision on Oral Wegovy Pill for Obesity
Novo Nordisk; Wegovy; oral semaglutide; FDA approval; obesity treatment; GLP-1 pill; weight loss; cardiovascular risk
VectorY Strikes $1.2B Option and License Pact with Shape Therapeutics for Brain-Penetrant Gene Therapy Delivery
VectorY Therapeutics; Shape Therapeutics; SHP-DB1; adeno-associated virus (AAV) capsid; brain-penetrant delivery; gene therapy; neurodegenerative diseases; Huntington’s disease; Alzheimer’s disease; biobucks; pipeline; milestone payments; vectorized antibodies
Lilly’s Mounjaro Shows Strong Results in Youth Type 2 Diabetes, Paving Way for Expansion
Mounjaro; tirzepatide; type 2 diabetes; children; adolescents; SURPASS-PEDS; A1C reduction; BMI reduction; clinical trial; Eli Lilly
Roche Acquires 89bio with $2.4 Billion Buyout to Enter FGF21 MASH Therapeutics Space
Roche; 89bio; acquisition; FGF21; pegozafermin; MASH; metabolic dysfunction-associated steatohepatitis; liver disease; biotech; contingent value rights; cardiometabolic diseases
Novo Nordisk and Bristol Myers Squibb Announce Major Layoffs in New Jersey
Novo Nordisk; Bristol Myers Squibb; layoffs; New Jersey; pharmaceutical industry; restructuring; job cuts; Ozempic; Wegovy; workforce reduction