Regulatory

• Regulatory

Bayer’s Hyrnuo set for the NSCLC frontlines on accelerated FDA label expansion

pharminent September 10, 2026

• Regulatory

HHS appoints permanent FDA CBER, CDER heads

pharminent September 10, 2026

• Regulatory

FDA approves AstraZeneca’s Etcamah combo for advanced breast cancer

pharminent September 7, 2026

• Regulatory

Ionis nets Zanvastro US approval in first for Alexander disease

pharminent September 4, 2026

• Regulatory

FDA OKs Takeda, Protagonist drug for rare blood cancer

pharminent August 31, 2026

• Regulatory

FDA clears Takeda, Protagonist’s first-in-class PV drug

pharminent August 31, 2026

• Regulatory

FDA green lights Priovant drug for rare skin disease

pharminent August 28, 2026

• Regulatory

Neurocrine receives FDA IND Acceptance for Alzheimer’s Ph2

pharminent August 26, 2026

• Regulatory

Jazz secures FDA approval for Ziihera in advanced HER2+ GEA

pharminent August 26, 2026

• Regulatory

Roche, Eli Lilly get FDA nod for new Alzheimer’s blood test

pharminent August 25, 2026

• Regulatory

Expanded US Imaavy approval first ever for wAIHA

pharminent August 25, 2026

• Regulatory

FDA greenlights Roche’s biomarker blood test for Alzheimer’s

pharminent August 25, 2026

• Regulatory

FDA places clinical hold on Regenxbio’s RGX-121 in MPS II trial

pharminent August 25, 2026

• Regulatory

Capricor’s Duchenne therapy has new life after FDA grants 3-month extension

pharminent August 24, 2026

• Regulatory

Johnson & Johnson’s multiple myeloma treatment secures EC approval

pharminent August 24, 2026

• Regulatory

UK MHRA authorises orforglipron private prescription

pharminent August 24, 2026

• Regulatory

Ultragenyx wins FDA approval for first treatment targeting root cause of GSDIa

pharminent August 20, 2026

• Regulatory

Regeneron wins FDA approval to challenge Ipsen for rare bone disease market

pharminent August 20, 2026

• Regulatory

FDA grants accelerated approval to Ultragenyx’s Genglycos gene therapy

pharminent August 20, 2026

• Regulatory

Trump nominates policy aide Overton to lead FDA

pharminent August 19, 2026

• Regulatory

Lantheus Holdings’ Alzheimer’s radiodiagnostic secures FDA approval

pharminent August 17, 2026

• Regulatory

BMS bags first approval for myeloma CELMoD Zenbexus

pharminent August 14, 2026

• Regulatory

UK regulators greenlight Lilly’s Foundayo, intensifying Novo competition

pharminent August 11, 2026

• Regulatory

Replimune rebounds to win FDA approval of melanoma drug

pharminent August 6, 2026

• Regulatory

Takeda’s first-in-class narcolepsy drug claims FDA approval

pharminent August 6, 2026

• Regulatory

Outlook Therapeutics Secures FDA Approval for LYTENAVA

pharminent July 31, 2026

• Regulatory

Outlook finally claims FDA approval for AMD drug

pharminent July 27, 2026

• Regulatory

Outlook Therapeutics wins FDA approval for Lytenava in wet AMD

pharminent July 27, 2026

• Regulatory

Lilly plans Q1 2027 filing for obesity triple retatrutide

pharminent July 23, 2026

• Regulatory

GSK’s $10.6B Nuvalent bet pays off early as FDA approves lung cancer drug

pharminent July 23, 2026

• Regulatory

FDA grants traditional approval to Novartis’ Fabhalta for IgAN

pharminent July 17, 2026

• Regulatory

Merck dives into cholesterol with first FDA approval for oral PCSK9 inhibitor

pharminent July 16, 2026

• Regulatory

Celcuity gains FDA approval for closely watched breast cancer drug

pharminent July 15, 2026

• Regulatory

Celcuity gets FDA nod for first-in-class breast cancer drug

pharminent July 15, 2026

• Regulatory

FDA clears at-home start dose for Alzheimer’s drug Leqembi

pharminent July 14, 2026

• Regulatory

FDA posts new rejection letters days after confirming pause

pharminent July 13, 2026

• Regulatory

FDA approves MSD’s Keytruda combinations for MIBC

pharminent July 13, 2026

• Regulatory

FDA freezes CRL trove as ‘radical transparency’ push hits speedbump

pharminent July 9, 2026

• Regulatory

UK first in Europe to clear Boehringer’s IPF drug Jascayd

pharminent July 9, 2026

• Regulatory

EC approves AbbVie’s Tepkinly combination for follicular lymphoma

pharminent July 7, 2026