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Novartis still hasn't solved its lingering CAR-T manufacturing issues

Novartis still hasn't solved its lingering CAR-T manufacturing issues

Biopharma Dive

drug manufacturing

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Dermira secures FDA fast track status for lebrikizumab in atopic dermatitis

Dermira secures FDA fast track status for lebrikizumab in atopic dermatitis

Pharmaceutical Business Review

atopic dermatitis

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Foreign Drug Inspections Decline as FDA Hiring Struggles Continue

Foreign Drug Inspections Decline as FDA Hiring Struggles Continue

RAPS.org

drug manufacturing

foreign drug inspections

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FDA approves etectRx ‘digital pill’ as rivals struggle

FDA approves etectRx ‘digital pill’ as rivals struggle

Pharmaforum

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Is Congress Poised to Deal a Significant Blow to Hatch-Waxman and the Generic Drug Industry?

Is Congress Poised to Deal a Significant Blow to Hatch-Waxman and the Generic Drug Industry?

FDA Law Blog

Hatch Waxman Act

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3 Biotechs Facing FDA Approvals by Year's End

3 Biotechs Facing FDA Approvals by Year's End

Motley Fool

Intra-Cellular Therapies

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Court Decides FDA Can’t Regulate Device as Drug

Court Decides FDA Can’t Regulate Device as Drug

FDA Law Blog

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4 FDA Dates Biotech Investors Should Circle in December

4 FDA Dates Biotech Investors Should Circle in December

Motley Fool

anti-inflammatories

Bausch Health Companies

Intra-Cellular Therapies

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FDA Launches App for Reporting new Uses of Infectious Disease Drugs

FDA Launches App for Reporting new Uses of Infectious Disease Drugs

RAPS.org

infectious diseases

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Correvio slumps after FDA staffers say benefits of heart drug do not outweigh risks

Correvio slumps after FDA staffers say benefits of heart drug do not outweigh risks

Reuters

atrial fibrillation

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ViiV presses go on FDA filing for first-in-class HIV drug fostemsavir

ViiV presses go on FDA filing for first-in-class HIV drug fostemsavir

Pharmaforum

ViiV Healthcare

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FDA knocks down Enzyvant candidate on manufacturing concerns after plant inspection

FDA knocks down Enzyvant candidate on manufacturing concerns after plant inspection

Fierce Biotech

drug manufacturing

congenital athymia

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FDA approves Roche’s MRSA test, allowing for faster screening

FDA approves Roche’s MRSA test, allowing for faster screening

Pharmaforum

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While Novartis combats generic onslaught in the courts, FDA approves first Gilenya copycats

While Novartis combats generic onslaught in the courts, FDA approves first Gilenya copycats

Endpoints

multiple sclerosis

Torrent Pharmaceuticals

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Ipsen Plunges as FDA Halts Bone Drug Trial in Children on Safety Concerns

Ipsen Plunges as FDA Halts Bone Drug Trial in Children on Safety Concerns

Bloomberg

fibrodysplasia ossificans progressiva

osteochondromas

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After Zantac scare, FDA targets generic metformin for carcinogen tests

After Zantac scare, FDA targets generic metformin for carcinogen tests

Fierce Pharma

type 2 diabetes

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FDA to Heartburn Drug Manufacturers: Do Not Release Lots if NDMA is Above Acceptable Levels

FDA to Heartburn Drug Manufacturers: Do Not Release Lots if NDMA is Above Acceptable Levels

RAPS.org

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Senate panel confirms Stephen Hahn as next FDA commissioner

Senate panel confirms Stephen Hahn as next FDA commissioner

PM Live

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Troubled Immunomedics tries again at FDA after rejection

Troubled Immunomedics tries again at FDA after rejection

Fierce Biotech

sacituzumab govitecan

metastatic triple-negative breast cancer

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Bristol-Myers Squibb gets FDA breakthrough therapy status for Orencia to prevent GvHD

Bristol-Myers Squibb gets FDA breakthrough therapy status for Orencia to prevent GvHD

Pharmaceutical Business Review

Bristol-Myers Squibb

graft vs host disease

breakthrough status

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