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Regulatory Intelligence & Drug Approvals3 weeks agoPfizer’s Tukysa greenlit for earlier use in breast cancer
Pfizer gets FDA approval for maintenance use of its oral HER2 inhibitor Tukysa in breast cancer, which it hopes will unlock renewed sales growth.
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Regulatory Intelligence & Drug Approvals3 weeks agoWhat Is the Approval Process for Generic Drugs?
Overview of the FDA review and approval process for generic drugs
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Regulatory Intelligence & Drug Approvals3 weeks agoRequirements and Resources for Approved ANDAs
Requirements and Resources for Approved Abbreviated New Drug Applications (ANDAs), including changes to an approved ANDA, postmarketing reporting, promotional materials, annual facility fees, and content of...
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Regulatory Intelligence & Drug Approvals3 weeks agoFDA approves Pfizer’s Tukysa regimen for metastatic breast cancer
This regimen is indicated for adults with unresectable locally advanced or metastatic human epidermal growth factor 2-positive (HER2+) disease following induction treatment. The regulatory decision introduces...
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Regulatory Intelligence & Drug Approvals3 weeks agoOn the move: 4 rare disease companies hiring now
Biotechs developing therapeutics to treat rare diseases include two that received FDA approvals this year for drugs to treat spinal muscular atrophy and Alexander disease.
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Regulatory Intelligence & Drug Approvals3 weeks agoAbbVie’s Telisotuzumab Adizutecan (Temab-A) Receives Two Breakthrough Therapy Designations From the U.S. FDA for CRC and NSCLC
NORTH CHICAGO, Ill., Oct. 7, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has granted two Breakthrough Therapy...
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Regulatory Intelligence & Drug Approvals3 weeks ago
Novartis Rhapsido (remibrutinib) Receives FDA Approval as First Treatment for Symptomatic Dermographism
Basel, October 7, 2026 – Novartis announced today that the U.S. Food and Drug Administration (FDA) approved Rhapsido® (remibrutinib), an oral, highly selective Bruton’s tyrosine kinase...
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Regulatory Intelligence & Drug Approvals3 weeks agoFDA approves tucatinib with trastuzumab and pertuzumab for the maintenance treatment of HER2-positive breast cancer
On October 7, 2026, the Food and Drug Administration approved tucatinib (Tukysa, Seagen Inc., a subsidiary of Pfizer) in combination with trastuzumab and pertuzumab for the...
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Regulatory Intelligence & Drug Approvals3 weeks agoCerevance Parkinson’s drug shortens ‘off time’ in Ph. 3, paving path to FDA
The Takeda spinout showed that a high dose of solengepras can shorten the periods during which difficult Parkinson’s disease symptoms like involuntary movements and sleepiness.
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Regulatory Intelligence & Drug Approvals4 weeks ago5 key facts about the FDA expedited IND pilot program
The program, part of Operation TrialBlazer, aims to speed early research and help the U.S. bring trials back from overseas.
Widespread atropine use fails to sway FDA advisors on Sydnexis data
At least 11 PDUFAs on FDA’s November docket
FDA Grants Accelerated Approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for Recurrent Respiratory Papillomatosis
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
