IPP Bureau
USFDA issues Form 483 with 6 observations to Enzene Biosciences’ Chakan plant following PAI
By IPP Bureau - February 17, 2026
The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.
Lupin partners with Spektus Pharma to commercialize DeslaFlex antidepressant in Canada
By IPP Bureau - February 17, 2026
DeslaFlex is an innovative antidepressant formulation developed by Spektus using the proprietary Flexitab oral drug-delivery platform
Sanofi Healthcare expands Hyderabad Global Hub, boosts capacity to 4,500 staff
By IPP Bureau - February 17, 2026
Backed by a multi-hundred-million-dollar investment, the expansion underscores Sanofi’s long-term commitment to India’s thriving life sciences ecosystem
Lilly’s Retevmo shows major survival boost in early-stage RET fusion lung cancer
By IPP Bureau - February 17, 2026
The trial, which compared Retevmo to placebo, met its primary endpoint with a “highly statistically significant and clinically meaningful improvement” in investigator-assessed EFS for patients with stage II–IIIA disease
Roche’s Gazyva hits major milestone in rare kidney disease
By IPP Bureau - February 17, 2026
Primary membranous nephropathy is a chronic autoimmune disease that attacks the kidneys’ filtering units
Biofrontera scores FDA filing acceptance for Ameluz PDT in skin cancer breakthrough
By IPP Bureau - February 16, 2026
If approved, Ameluz would become the first and only photodynamic therapy (PDT) photosensitizer for sBCC in the US
Dewpoint Therapeutics selects groundbreaking MYC development candidate
By IPP Bureau - February 16, 2026
MYC, a master regulator of oncogenic transcription, drives multiple high-burden cancers but has long eluded direct pharmacologic control
STADA & Bio-Thera bag European nod for Gotenfia
By IPP Bureau - February 16, 2026
Clinigen bags Japan's nod to human milk-based medicine for preterm infants
By IPP Bureau - February 16, 2026
PreemieFort Enteral Solution's approval marks the first time a nutritional product derived from human milk has been recognized as a prescription medicine anywhere in the world
Amgen scores EU nod for UPLIZNA in rare autoimmune disease
By IPP Bureau - February 16, 2026
The approval marks a major advance in targeted treatment for this rare, chronic autoimmune disease, offering twice-yearly maintenance dosing after two initial loading doses
Lundbeck’s bocunebart shows breakthrough potential in migraine prevention
By IPP Bureau - February 16, 2026
Bocunebart works by blocking pituitary adenylate cyclase-activating polypeptide
BridgeBio reports breakthrough results in Phase 3 achondroplasia trial
By IPP Bureau - February 16, 2026
Achondroplasia is a genetic condition driven by FGFR3 that affects more than stature alone
Lyell Immunopharma launches groundbreaking Phase 3 CAR T-Cell trial for aggressive lymphoma
By IPP Bureau - February 16, 2026
PiNACLE is a head-to-head study comparing its next-generation CAR T-cell therapy against established therapies liso-cel and axi-cel in patients with relapsed or refractory large B-cell lymphoma
Centivax launches first human trial of universal flu vaccine
By IPP Bureau - February 16, 2026
Agilent’s PD-L1 test gains FDA nod for ovarian cancer
By IPP Bureau - February 16, 2026
This approval represents the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx with KEYTRUDA
