Can adhesion and lower estrogen dosing make Viatris’s contraceptive patch stand out?
Viatris has patch expertise. FDA scrutiny now decides whether lower estrogen and adhesion data can turn MR-100A-01 into a real growth lever.
Can direct to consumer access help Vanda scale NEREUS beyond niche travel use?
Motion sickness finally has a new prescription drug. Vanda’s test is whether NEREUS can move beyond travel novelty into real demand.
Could Capitan Orthopedics’ SupraSpacer reshape irreparable rotator cuff tear treatment?
Rotator cuff care has a treatment gap. Capitan Orthopedics’ SupraSpacer now has FDA breakthrough status, but evidence will decide adoption.
Rezolute’s ersodetug data deepens the congenital hyperinsulinism regulatory debate
Rezolute, Inc. has presented expanded Phase 3 sunRIZE data for ersodetug in congenital hyperinsulinism at the Pediatric Endocrine Society Annual Meeting, adding continuous glucose monitoring outcomes and open-label extension observations to a program that previously missed its primary endpoint. The update places the late-stage rare disease biotech firm in a complex regulatory position, as the […]
Is BRC Therapeutics opening a new regulatory lane for cannabinoid-based CRPS therapies?
CRPS has no approved U.S. therapy. BRC-002 now has an FDA path, but proof of safety, efficacy, and dosing discipline still lies ahead.
How Apotex’s generic Infuvite pediatric approval could shift the sterile injectable multivitamin market
Pediatric nutrition needs reliable sterile supply. Apotex’s Infuvite generic approval tests whether complex generics can ease that gap.
Johnson & Johnson’s CAPLYTA update raises the bar for long-term schizophrenia stability
Schizophrenia drugs face a durability test. CAPLYTA’s FDA update gives Johnson & Johnson a stronger long-term stability story.
What ZORYVE cream’s infant indication means for non-steroidal eczema treatments
Can ZORYVE cream transform infant eczema care? Explore what this FDA filing means for non-steroidal treatment strategies today.
Sanofi’s Tzield gains pediatric approval but can early intervention truly change T1D outcomes
FDA expands Tzield use to young children with type 1 diabetes. Discover what this means for early intervention and long-term outcomes.
AbbVie’s fast-acting Botox rival just hit a regulatory wall, but not where investors feared
AbbVie’s TrenibotulinumtoxinE faces an FDA manufacturing CRL. Find out what this means for approval, aesthetics and neurotoxins.