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FDA Approvals

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3 ARTICLES

4d ago

FDA Approves Datroway as First‑Line Option for Immunotherapy‑Ineligible Triple‑Negative Breast Cancer

Regulators cleared the TROP2‑targeting antibody‑drug conjugate after Phase III data showed a meaningful survival benefit versus chemotherapy, creating a new first‑line choice for patients who cannot receive PD‑1/PD‑L1 therapy.

6 ARTICLES

6d ago

EMA Validates Astellas Bid to Add Padcev–Keytruda Combo for Perioperative Muscle-Invasive Bladder Cancer

3 ARTICLES

last mo.

SCYNEXIS Acquires Poxel’s PXL-770 for ADPKD, Plans 2026 Phase 2 Trial

3 ARTICLES

last mo.

FDA Clears Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes

10 ARTICLES

last mo.

FDA Grants Accelerated Approval to Kresladi, First Gene Therapy for Severe Pediatric LAD-1

3 ARTICLES

2mo ago

Taysha Advances Rett Gene Therapy Program With Pivotal Dosing, FDA Alignment and Q2 Data Timeline

10 ARTICLES

2mo ago

FDA Clears J&J’s Icotyde, First Oral IL-23 Psoriasis Therapy for Ages 12 and Up

4 ARTICLES

2mo ago

Iovance Shares Hit Record After UBS Doubles Price Target

8 ARTICLES

3mo ago

Lilly Launches FDA-Cleared Monthly Zepbound KwikPen on LillyDirect at $299 Starter Price

4 ARTICLES

4mo ago

Sarepta Reports 3-Year EMBARK Data Showing Elevidys Slows Duchenne Progression

3 ARTICLES

4mo ago

FDA Clears Medtronic’s MiniMed Go App Linking InPen With Abbott’s Instinct CGM

11 ARTICLES

5mo ago

FDA Approves First Wegovy Pill for Chronic Weight Management

5 ARTICLES

5mo ago

AstraZeneca’s LATIFY Phase 3 Finds No Survival Benefit for Ceralasertib Plus Imfinzi in Pre-Treated NSCLC

5 ARTICLES

5mo ago

FDA Approves Rybrevant Faspro, a 5‑Minute Subcutaneous Amivantamab for EGFR‑Mutated Lung Cancer

8 ARTICLES

5mo ago

FDA Clears First New Oral Gonorrhea Antibiotics in Over 30 Years

5 ARTICLES

5mo ago

Kyverna CAR-T Delivers Positive Phase 2 Topline in Stiff Person Syndrome as Shares Jump

FDA Approvals

FDA Approves Datroway as First‑Line Option for Immunotherapy‑Ineligible Triple‑Negative Breast Cancer

FDA Accepts ImmunityBio Filing to Expand ANKTIVA Use in Bladder Cancer

FDA Approves Bizengri for NRG1 Fusion-Positive Cholangiocarcinoma

FDA Approves Langlara as Interchangeable Biosimilar to Lantus

Regeneron Tops Q1 Estimates as Dupixent and Libtayo Outpace Eylea

EMA Validates Astellas Bid to Add Padcev–Keytruda Combo for Perioperative Muscle-Invasive Bladder Cancer

SCYNEXIS Acquires Poxel’s PXL-770 for ADPKD, Plans 2026 Phase 2 Trial

FDA Clears Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes

FDA Grants Accelerated Approval to Kresladi, First Gene Therapy for Severe Pediatric LAD-1

Taysha Advances Rett Gene Therapy Program With Pivotal Dosing, FDA Alignment and Q2 Data Timeline

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FDA Approvals

FDA Clears J&J’s Icotyde, First Oral IL-23 Psoriasis Therapy for Ages 12 and Up

Iovance Shares Hit Record After UBS Doubles Price Target

Lilly Launches FDA-Cleared Monthly Zepbound KwikPen on LillyDirect at $299 Starter Price

Sarepta Reports 3-Year EMBARK Data Showing Elevidys Slows Duchenne Progression

FDA Clears Medtronic’s MiniMed Go App Linking InPen With Abbott’s Instinct CGM

FDA Approves First Wegovy Pill for Chronic Weight Management

AstraZeneca’s LATIFY Phase 3 Finds No Survival Benefit for Ceralasertib Plus Imfinzi in Pre-Treated NSCLC

FDA Approves Rybrevant Faspro, a 5‑Minute Subcutaneous Amivantamab for EGFR‑Mutated Lung Cancer

FDA Clears First New Oral Gonorrhea Antibiotics in Over 30 Years

Kyverna CAR-T Delivers Positive Phase 2 Topline in Stiff Person Syndrome as Shares Jump

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FDA Approvals