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U.S. Food and Drug Administration

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Representative image: Mabwell’s 9MW5211 FDA clearance highlights growing clinical interest in first-in-class antibody therapies for inflammatory bowel disease, as biotech developers target pathogenic immune cells to reshape autoimmune disease treatment.
Pharma & Biotech

Mabwell’s 9MW5211 gets FDA clearance, but can a first-in-class autoimmune antibody break through?

Mabwell has FDA clearance for 9MW5211. The bigger test is whether a first-in-class autoimmune antibody can prove durable remission.

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Representative image: Aptar Pharma’s FDA-funded research into next-generation propellants highlights the scientific complexity behind greener metered-dose inhalers, where aerosol performance, device design and bioequivalence testing could shape the future of respiratory drug delivery.
Medical Devices & Diagnostics

Can Aptar Pharma help solve the bioequivalence challenge in next-generation inhalers?

Greener inhalers need more than lower-carbon chemistry. Aptar Pharma’s FDA-backed work tests the science regulators may need.

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Representative image of a blood glucose monitoring meter showing an error warning, highlighting why Trividia Health’s TRUE METRIX correction has put diabetes device safety, glucose meter labeling, and patient risk communication under sharper scrutiny.
Medical Devices & Diagnostics

What Trividia Health’s TRUE METRIX correction reveals about diabetes device risk communication

Trividia’s TRUE METRIX correction is no routine label fix. Glucose meter safety now hinges on software, usability, and upgrade execution.

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Representative image of a weekly contraceptive patch being assessed in a clinical setting, reflecting Viatris Inc.’s MR-100A-01 data update as the FDA review places low-dose estrogen transdermal contraception back in focus.
Pharma & Biotech

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.

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Representative image: A ferry passenger experiencing motion sickness, reflecting Vanda Pharmaceuticals Inc.’s U.S. launch of NEREUS as a new prescription treatment option for adults with vomiting induced by motion.
Pharma & Biotech

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.

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Representative image of an orthopedic shoulder implant concept, highlighting how Capitan Orthopedics’ SupraSpacer could address the treatment gap for irreparable rotator cuff tears after receiving FDA Breakthrough Device Designation.
Medical Devices & Diagnostics

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.

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Representative image: Continuous glucose monitoring data in a clinical setting highlights the regulatory and clinical questions surrounding Rezolute’s ersodetug data for congenital hyperinsulinism after the Phase 3 sunRIZE study.
Pharma & Biotech

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

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Pharma & Biotech

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.

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Representative image of sterile injectable medicine vials being reviewed in a hospital pharmacy setting, reflecting how Apotex’s generic Infuvite Pediatric Injection approval could expand access to pediatric parenteral nutrition and complex generic injectables in the United States.
Pharma & Biotech

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.

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Representative image of a clinical consultation on long-term schizophrenia care, as Johnson & Johnson’s CAPLYTA FDA label update sharpens focus on relapse prevention, treatment stability, and durability in neuropsychiatric therapy.
Pharma & Biotech

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.

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