Regulatory Affairs

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3 ARTICLES

last mo.

Wake County Approves Move Toward Atrium–WakeMed Combination

The vote sends the agreement to state regulators after Atrium pledged $2 billion and the amended deal added a $150 million county health fund, stronger charity-care minimums and a cap on near-term price increases alongside the governor's non-opposition.

3 ARTICLES

2mo ago

EU Safety Committee Opens Class Review of Injectable Iron Over Low-Phosphate and Bone Risks

3 ARTICLES

2mo ago

Cipla Reports 39% Drop in Q1 Profit as U.S. Generics Prices and Lanreotide Halt Bite

4 ARTICLES

4mo ago

EMA Committee Recommends Revoking Tavneos Authorization

3 ARTICLES

5mo ago

MediWound Posts Weak Q1 but Reaffirms 2026 Revenue Target as BARDA Deal and Factory Upgrades Drive H2 Plan

3 ARTICLES

5mo ago

Cormedix Lifts 2026 Outlook After Q1 Beat, Sets H2 FDA Filing Plan for Rizzeo

3 ARTICLES

5mo ago

FDA Says Estrogen Patches Not in Official Shortage as Pharmacies Report Scarcity

3 ARTICLES

6mo ago

Evolus Posts Q1 Growth and Second Straight Positive Adjusted EBITDA, Reaffirms 2026 Outlook

4 ARTICLES

6mo ago

iRhythm Lifts 2026 Outlook After Strong Q1 Growth and Margin Gains

3 ARTICLES

6mo ago

Cerus Raises 2026 Outlook After 24% Q1 Product Revenue Jump as INT200 Filing Nears

3 ARTICLES

6mo ago

ARCHIMED to Acquire Esperion for $3.16 a Share Plus CVR

7 ARTICLES

6mo ago

Hyderabad Paediatrician Quits IAP After Legal Notices Over ORS Marketing Row

3 ARTICLES

7mo ago

Delhi Court Pauses DRL’s ‘Olymviq’ Rollout in Ozempic Trademark Fight

5 ARTICLES

7mo ago

ENvue Medical Lands Detroit Teaching Hospital, Lifting U.S. Footprint to 39 Sites

4 ARTICLES

7mo ago

Co-Diagnostics Expands CoSara Territory to Four South Asian Countries

Regulatory Affairs

Wake County Approves Move Toward Atrium–WakeMed Combination

EU Safety Committee Opens Class Review of Injectable Iron Over Low-Phosphate and Bone Risks

Clear Eyes Recalls Nearly 40,000 Bottles Over Sterility Concerns

FDA Approves Moderna mRNA Flu Vaccine for Adults 50 and Older

Natera Shares Surge After Blowout Signatera Quarter and Japan Approval

Iovance Posts Record Q2 Revenue on Strong Amtagvi Sales

Dexcom Beats Q2 Expectations and Lifts 2026 Outlook

Cipla Reports 39% Drop in Q1 Profit as U.S. Generics Prices and Lanreotide Halt Bite

EMA Committee Recommends Revoking Tavneos Authorization

MediWound Posts Weak Q1 but Reaffirms 2026 Revenue Target as BARDA Deal and Factory Upgrades Drive H2 Plan

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Regulatory Affairs

Cormedix Lifts 2026 Outlook After Q1 Beat, Sets H2 FDA Filing Plan for Rizzeo

FDA Says Estrogen Patches Not in Official Shortage as Pharmacies Report Scarcity

Evolus Posts Q1 Growth and Second Straight Positive Adjusted EBITDA, Reaffirms 2026 Outlook

iRhythm Lifts 2026 Outlook After Strong Q1 Growth and Margin Gains

Cerus Raises 2026 Outlook After 24% Q1 Product Revenue Jump as INT200 Filing Nears

ARCHIMED to Acquire Esperion for $3.16 a Share Plus CVR

Hyderabad Paediatrician Quits IAP After Legal Notices Over ORS Marketing Row

Delhi Court Pauses DRL’s ‘Olymviq’ Rollout in Ozempic Trademark Fight

ENvue Medical Lands Detroit Teaching Hospital, Lifting U.S. Footprint to 39 Sites

Co-Diagnostics Expands CoSara Territory to Four South Asian Countries

Never miss stories about

Regulatory Affairs